132 results on '"Yitshak Kreiss"'
Search Results
2. Humoral Immunity of Unvaccinated COVID-19 Recovered vs. Naïve BNT162b2 Vaccinated Individuals: A Prospective Longitudinal Study
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Gili Joseph, Carmit Cohen, Carmit Rubin, Havi Murad, Victoria Indenbaum, Keren Asraf, Yael Weiss-Ottolenghi, Gabriella Segal-Lieberman, Yitshak Kreiss, Yaniv Lustig, and Gili Regev-Yochay
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immunoglobulin G ,antibodies ,neutralizing ,immunity ,humoral ,COVID-19 ,Biology (General) ,QH301-705.5 - Abstract
To study the differences in the immune response to SARS-CoV-2 infection compared to the response to vaccination, we characterized the humoral immune kinetics of these situations. In this prospective longitudinal study, we followed unvaccinated COVID-19-recovered individuals (n = 130) and naïve, two-dose BNT162b2-vaccinated individuals (n = 372) who were age- and BMI-matched for six months during the first pandemic year. Anti-RBD-IgG, neutralizing antibodies (NAbs), and avidity were assessed monthly. For recovered patients, data on symptoms and the severity of the disease were collected. Anti-RBD-IgG and NAbs titers at peak were higher after vaccination vs. after infection, but the decline was steeper (peak log IgG: 3.08 vs. 1.81, peak log NAbs: 5.93 vs. 5.04, slopes: −0.54 vs. −0.26). Peak anti-RBD-IgG and NAbs were higher in recovered individuals with BMI > 30 and in older individuals compared to individuals with BMI < 30, younger population. Of the recovered, 42 (36%) experienced long-COVID symptoms. Avidity was initially higher in vaccinated individuals compared with recovered individuals, though with time, it increased in recovered individuals but not among vaccinated individuals. Here, we show that while the initial antibody titers, neutralization, and avidity are lower in SARS-CoV-2-recovered individuals, they persist for a longer duration. These results suggest differential protection against COVID-19 in recovered-unvaccinated vs. naïve-vaccinated individuals.
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- 2023
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3. Remote ischemic preconditioning improves tissue oxygenation in a porcine model of controlled hemorrhage without fluid resuscitation
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Gal Yaniv, Arik Eisenkraft, Lilach Gavish, Linn Wagnert-Avraham, Dean Nachman, Jacob Megreli, Gil Shimon, Daniel Rimbrot, Ben Simon, Asaf Berman, Matan Cohen, David Kushnir, Ruth Shaylor, Baruch Batzofin, Shimon Firman, Amir Shlaifer, Michael Hartal, Yuval Heled, Elon Glassberg, Yitshak Kreiss, and S. David Gertz
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Medicine ,Science - Abstract
Abstract Remote ischemic preconditioning (RIPC) involves deliberate, brief interruptions of blood flow to increase the tolerance of distant critical organs to ischemia. This study tests the effects of limb RIPC in a porcine model of controlled hemorrhage without replacement therapy simulating an extreme field situation of delayed evacuation to definitive care. Twenty-eight pigs (47 ± 6 kg) were assigned to: (1) control, no procedure (n = 7); (2) HS = hemorrhagic shock (n = 13); and (3) RIPC + HS = remote ischemic preconditioning followed by hemorrhage (n = 8). The animals were observed for 7 h after bleeding without fluid replacement. Survival rate between animals of the RIPC + HS group and those of the HS group were similar (HS, 6 of 13[46%]-vs-RIPC + HS, 4 of 8[50%], p = 0.86 by Chi-square). Animals of the RIPC + HS group had faster recovery of mean arterial pressure and developed higher heart rates without complications. They also had less decrease in pH and bicarbonate, and the increase in lactate began later. Global oxygen delivery was higher, and tissue oxygen extraction ratio lower, in RIPC + HS animals. These improvements after RIPC in hemodynamic and metabolic status provide essential substrates for improved cellular response after hemorrhage and reduction of the likelihood of potentially catastrophic consequences of the accompanying ischemia.
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- 2021
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4. Author Correction: Immunogenicity and efficacy of fourth BNT162b2 and mRNA1273 COVID-19 vaccine doses; three months follow-up
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Michal Canetti, Noam Barda, Mayan Gilboa, Victoria Indenbaum, Michal Mandelboim, Tal Gonen, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Ram Doolman, Ella Mendelson, Dror Harats, Laurence S. Freedman, Yitshak Kreiss, Yaniv Lustig, and Gili Regev-Yochay
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Science - Published
- 2023
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5. Sleep Difficulties Among COVID-19 Frontline Healthcare Workers
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Rony Cleper, Nimrod Hertz-Palmor, Mariela Mosheva, Ilanit Hasson-Ohayon, Rachel Kaplan, Yitshak Kreiss, Arnon Afek, Itai M. Pessach, Doron Gothelf, and Raz Gross
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sleep ,sleep difficulties ,COVID-19 ,health care workers (HCW) ,COVID-19 outbreak ,sleep disorders ,Psychiatry ,RC435-571 - Abstract
ObjectiveTo identify COVID-19 work-related stressors and experiences associated with sleep difficulties in HCW, and to assess the role of depression and traumatic stress in this association.MethodsA cross-sectional study of HCW using self-report questionnaires, during the first peak of the pandemic in Israel (April 2020), conducted in a large tertiary medical center in Israel. Study population included 189 physicians and nurses working in designated COVID-19 wards and a comparison group of 643 HCW. Mean age of the total sample was 41.7 ± 11.1, 67% were female, 42.1% physicians, with overall mean number of years of professional experience 14.2 ± 20. The exposure was working in COVID-19 wards and related specific stressors and negative experiences. Primary outcome measurement was the Insomnia Severity Index (ISI). Secondary outcomes included the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5); the Patient Health Questionnaire-9 (PHQ-9) for depression; the anxiety module of the Patient-Reported Outcomes Measurement Information System (PROMIS); Pandemic-Related Stress Factors (PRSF) and witnessing patient suffering and death.ResultsCompared with non-COVID-19 HCW, COVID-19 HCW were more likely to be male (41.3% vs. 30.7%) and younger (36.91 ± 8.81 vs. 43.14 ± 11.35 years). COVID-19 HCW reported higher prevalence of sleep difficulties: 63% vs. 50.7% in the non-COVID group (OR 1.62, 95% CI 1.15–2.29, p = 0.006), mostly difficulty maintaining sleep: 26.5% vs. 18.5% (OR 1.65, 95% CI 1.11–2.44, p = 0.012). Negative COVID-19 work-related experiences, specifically witnessing patient physical suffering and death, partially explained the association. Although past psychological problems and current depression and PTSD were associated with difficulty maintaining sleep, the main association remained robust also after controlling for those conditions in the full model.Conclusion and RelevanceCOVID-19 frontline HCW were more likely to report sleep difficulties, mainly difficulty maintaining sleep, as compared with non-COVID-19 HCW working at the same hospital. Negative patient-care related experiences likely mediated the increased probability for those difficulties. Future research is needed to elucidate the long-term trajectories of sleep difficulties among HCW during large scale outbreaks, and to identify risk factors for their persistence.
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- 2022
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6. The Use of Rapid COVID-19 Antigen Test in the Emergency Department as a Decision-Support Tool
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Lilac Meltzer, Sharon Amit, Mayan Gilboa, Ilana Tal, Bella Mechnik, Avi Irony, Hindi Engelrad, Avi Epstein, Yael Frenkel-Nir, Yuval Levy, Yitshak Kreiss, and Gili Regev-Yochay
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COVID-19 ,SARS-CoV-19 ,antigen ,rapid tests ,emergency department ,triage ,Biology (General) ,QH301-705.5 - Abstract
The emergency department (ED) is the initial point of contact between hospital staff and patients potentially infected with SARS-CoV-2, thus, prevention of inadvertent exposure to other patients is a top priority. We aimed to assess whether the introduction of antigen-detecting rapid diagnostic tests (Ag-RDTs) to the ED affected the likelihood of unwanted SARS-CoV-2 exposures. In this retrospective single-center study, we compared the rate of unwarranted exposure of uninfected adult ED patients to SARS-CoV-2 during two separate research periods; one before Ag-RDTs were introduced, and one with Ag-RDT used as a decision-support tool. The introduction of Ag-RDTs to the ED significantly decreased the relative risk of SARS-CoV-2-negative patients being incorrectly assigned to the COVID-19 designated site (“red ED”), by 97%. There was no increase in the risk of SARS-CoV-2-positive patients incorrectly assigned to the COVID-19-free site (“green ED”). In addition, duration of ED admission was reduced in both the red and the green ED. Therefore, implementing the Ag-RDT-based triage protocol proved beneficial in preventing potential COVID-19 nosocomial transmission.
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- 2023
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7. Reduced Neutralization Efficacy against Omicron Variant after Third Boost of BNT162b2 Vaccine among Liver Transplant Recipients
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Yana Davidov, Victoria Indenbaum, Michal Mandelboim, Keren Asraf, Tal Gonen, Keren Tsaraf, Oranit Cohen-Ezra, Mariya Likhter, Ital Nemet, Limor Kliker, Orna Mor, Ram Doolman, Carmit Cohen, Arnon Afek, Yitshak Kreiss, Gili Regev-Yochay, Yaniv Lustig, and Ziv Ben-Ari
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BNT162b2 vaccine ,neutralizing antibody ,third vaccine dose ,liver transplant recipients ,Omicron ,Microbiology ,QR1-502 - Abstract
The immune responses of liver transplant (LT) recipients after the third boost of the BNT162b2mRNA vaccine improved. This study evaluates the durability of the immune response of LT recipients after the third boost, its predictors, and the impact of emerging variants. The receptor-binding domain IgG was determined at median times of 22 (first test) and 133 days (second test) after the administration of the third boost. IgG antibody titers > 21.4 BAU/mL were defined as a positive response. The neutralization efficacies of the vaccine against the wild-type, Omicron, and Delta variants were compared in the first test. The 59 LT recipients were of a median age of 61 years (range 25–82); 53.5% were male. Following administration of the third dose, the positive immune response decreased from 81.4% to 76.3% between the first and second tests, respectively, (p < 0.0001). The multivariate analysis identified CNI monotherapy (p = 0.02) and hemoglobin > 12 g/dL (p = 0.02) as independent predictors of a maintained positive immune response 133 days after the third dose. The geometric mean titers of Omicron neutralization were significantly lower than the wild-type and Delta virus (21, 137, 128, respectively; p < 0.0001). The immune response after the third BNT162b2mRNA vaccine dose decreased significantly in LT recipients. Further studies are required to evaluate the efficacy of the fourth vaccine dose and the durability of the immune response.
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- 2023
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8. High Immune Response Rate to the Fourth Boost of the BNT162b2 Vaccine against the Omicron Variants of Concern among Liver Transplant Recipients
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Yana Davidov, Victoria Indenbaum, Nofar Atari, Limor Kliker, Keren Tsaraf, Keren Asraf, Oranit Cohen-Ezra, Mariya Likhter, Orna Mor, Ram Doolman, Yael Weiss-Ottolenghi, Tammy Hod, Arnon Afek, Yitshak Kreiss, Yaniv Lustig, Gili Regev-Yochay, Michal Mandelboim, and Ziv Ben-Ari
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BNT162b2 mRNA ,fourth dose ,liver transplant recipients ,breakthrough infection ,immune response ,side effects BNT162b2 mRNA vaccine ,Microbiology ,QR1-502 - Abstract
The immune response of liver transplant (LT) recipients to a third dose of the BNT162b2 mRNA vaccine significantly waned after four months. We aimed to evaluate the immune response and breakthrough infection rates of a fourth dose against the Omicron variants among LT recipients. LT recipients who had no past or active SARS-CoV-2 infection and received three doses of the BNT162b2mRNA vaccine were included. Of the 73 LT recipients, 50 (68.5%) received a fourth dose. The fourth dose was associated with a significantly higher positive immune response than the third dose. Receptor-binding domain (RBD) IgG and Omicron BA.1 and BA.2 neutralizing antibodies were determined at a median of 132 and 29 days after the third and fourth vaccines. They were 345 binding antibody units per milliliter (BAU/mL) vs. 2118 BAU/mL (p < 0.0001), 10 vs. 87 (p < 0.0001), and 15 vs. 149 (p = 0.001), respectively. Breakthrough infections were documented among nine (18%) LT recipients after the fourth dose and among seven (30.4%) patients following the third dose (p = 0.2); 93.5% of breakthrough infections were mild. The infection rate after the fourth dose was higher among diabetic vs. nondiabetic recipients (33.3% vs. 6.9%, respectively; p = 0.02). Further studies are needed to evaluate additional factors influencing the breakthrough infection rate among LT recipients.
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- 2022
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9. Real-World Immunogenicity and Reactogenicity of Two Doses of Pfizer-BioNTech COVID-19 Vaccination in Children Aged 5–11 Years
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Gili Joseph, Elisheva Klein, Yaniv Lustig, Yael Weiss-Ottolenghi, Keren Asraf, Victoria Indenbaum, Sharon Amit, Or Kriger, Mayan Gilboa, Yuval Levy, Itai M. Pessach, Yitshak Kreiss, Gili Regev-Yochay, and Michal Stein
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COVID-19 ,antibodies ,children ,vaccines ,immunogenicity ,reactogenicity ,Medicine - Abstract
There are limited data concerning the immunogenicity and reactogenicity of COVID-19 vaccines in children. A total of 110 children, 5–11 years old were vaccinated with two doses (with a 3-week interval between doses) of the Pfizer-BioNTech COVID-19 vaccine and were followed for 21, 90, and 180 days after vaccination for immunogenicity, adverse events, and breakthrough infections. Ninety days after the first vaccine dose, the GeoMean (CI 95%) of IgG ascended to 1291.0 BAU (929.6–1790.2) for uninfected children and 1670.0 BAU (1131.0–2466.0) for Infected children. One hundred and eighty days after receiving the first dose of the vaccine, the titers decreased to 535.5 BAU (288.4–993.6) for the uninfected children, while only a small decline was detected among infected children—1479.0 (878.2–2490.0). The neutralizing antibodies titer almost did not change over time in the uninfected children, and even elevated for the infected children. Of the 110 vaccinated children, 75.5% were infected, with only mild COVID-19 infection symptoms. Child vaccination was found to be safe, with mild, mostly local, and of short duration, reported AEs. No serious adverse events (SAEs) were reported after vaccination. The durability of two doses of vaccine in children is longer, thus a booster may not be needed as early as in adults.
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- 2022
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10. Decreased infectivity following BNT162b2 vaccination: A prospective cohort study in Israel
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Gili Regev-Yochay, Sharon Amit, Moriah Bergwerk, Marc Lipsitch, Eyal Leshem, Rebecca Kahn, Yaniv Lustig, Carmit Cohen, Ram Doolman, Arnona Ziv, Ilya Novikov, Carmit Rubin, Irena Gimpelevich, Amit Huppert, Galia Rahav, Arnon Afek, and Yitshak Kreiss
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Public aspects of medicine ,RA1-1270 - Abstract
Background: BNT162b2 was shown to be 92% effective in preventing COVID-19. Prioritizing vaccine rollout, and achievement of herd immunity depend on SARS-CoV-2 transmission reduction. The vaccine's effect on infectivity is thus a critical priority. Methods: Among all 9650 HCW of a large tertiary medical center in Israel, we calculated the prevalence of positive SARS-CoV-2 qRT-PCR cases with asymptomatic presentation, tested following known or presumed exposure and the infectious subset (N-gene-Ct-value
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- 2021
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11. Buying Time with COVID-19 Outbreak Response, Israel
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Eyal Leshem, Arnon Afek, and Yitshak Kreiss
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containment ,Israel ,COVID-19 ,travel restrictions ,respiratory infections ,severe acute respiratory syndrome coronavirus 2 ,Medicine ,Infectious and parasitic diseases ,RC109-216 - Abstract
Israel's response during the containment phase of the COVID-19 outbreak in early 2020 led to a delay in sustained community transmission and effective mitigation. During February–April 2020, a total of 15,981 confirmed cases resulted in 223 deaths. A total of 179,003 persons reported electronically to self-quarantine and were entitled to paid sick leave.
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- 2020
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12. Anxiety and Depression Symptoms in COVID-19 Isolated Patients and in Their Relatives
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Shirel Dorman-Ilan, Nimrod Hertz-Palmor, Ayelet Brand-Gothelf, Ilanit Hasson-Ohayon, Noam Matalon, Raz Gross, Wendy Chen, Ayelet Abramovich, Arnon Afek, Amitai Ziv, Yitshak Kreiss, Itai M. Pessach, and Doron Gothelf
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anxiety ,depression ,COVID-19 ,patients ,relatives ,children ,Psychiatry ,RC435-571 - Abstract
Background: While focusing on the management and care of COVID-19 patients, the mental health of these patients and their relatives is being overlooked. The aim of the current study was to measure anxiety and depression, and to assess their association with socio-demographic and pandemic-related stress factors in COVID-19 patients and their relatives during the initial stage of hospitalization.Methods: We assessed isolated hospitalized patients (N = 90) and their relatives (adults and children, N = 125) by phone, 25–72 h following patients' admission. The quantitative measures included the Anxiety and Depression modules of the Patient-Reported Outcomes Measurement Information System (PROMIS) and pandemic-related stress factors. Qualitative measures included questions exploring worries, sadness, and coping modes.Results: Both patients and relatives suffer from high levels of anxiety and related pandemic worries, with lower levels of depressive symptoms. Compared to adult relatives, child relatives reported significantly lower anxiety. The multivariable logistic regression analysis revealed an increased risk for anxiety among females and a decreased risk among ultra-orthodox participants. While increased anxiety among patients was associated with feelings of isolation, increased anxiety among relatives was associated with a feeling of not being protected by the hospital.Conclusions: Patients and relatives experience similar high anxiety levels which are more robust in women and lower in ultra-orthodox participants. Our findings indicate that anxiety symptoms of both patients and adult relatives should be addressed.
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- 2020
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13. Qual a Contribuiçao do Tilt Training (treinamento postural) na Prevençao da Síncope Vasovagal?
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Osnat GUREVITZ, Alon BARSHESHET, David BAR-LEV, Eyal ZIMLICHMAN, Gail F. ROSENFELD, Michal BENDERLY, David LURIA, Howard AMITAL, Yitshak KREISS, Michael ELDAR, and Michael GLIKSON
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clinico, técnicas nao-invasivas - teste de head-up tilt, síncope vasovagal, síncope, prevençao, treinamento postural ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Histórico: A síncope vasovagal é um dos quadros clínicos mais comuns em adultos jovens. Estudos anteriores demonstram a eficiência do tilt training (treinamento postural) no tratamento desse transtorno clínico. Realizou-se um estudo prospectivo e randomizado com o objetivo de avaliar a contribuiçao do tilt training no tratamento de adultos jovens acometidos pela síncope vasovagal. Métodos: Quarenta e seis soldados, 25 dos quais do sexo masculino, média de idade de 19,4 ± 0,8 anos e diagnóstico clínico de síncope vasovagal pelo tilt test, foram divididos aleatoriamente em dois grupos: um grupo controle e outro submetido a tilt training diariamente, por três meses. Nos dois grupos, os participantes foram instruídos a aumentar a ingestao de líquidos e sal e evitar situaçoes indutoras da síncope, tais como permanecer em pé por períodos longos. Resultados: A adesao ao programa de treinamento, caracterizada pela realizaçao de 50% ou mais das sessoes diárias de tilt training, foi de 91% durante o primeiro mês, caindo para 58% nos três meses. Os que realizaram o treinamento apresentaram uma média (distância interquartílica) de 5,0 episódios de síncope (0,5 a 16,0) durante um ano de acompanhamento, enquanto o grupo controle apresentou média de 2,0 episódios (0 a 6,0; P = 0,737). Após a randomizaçao, nao houve diferença significativa no tempo de ocorrência do primeiro episódio de síncope entre os dois grupos: média de 1,0 por mês (0,5 a 2,0) no grupo em tratamento e 0,8 (0,5 a 2,0) no grupo controle (P = 0,336). Conclusoes: A realizaçao diária do tilt training, aliada às modificaçoes de estilo de vida, nao produziu melhora no resultado do tratamento de adultos jovens com síncope vasovagal. Verificou-se ainda a dificuldade de obter boa adesao ao programa de treinamento postural.
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- 2008
14. Correlates of protection against COVID-19 infection and intensity of symptomatic disease in vaccinated individuals exposed to SARS-CoV-2 in households in Israel (ICoFS): a prospective cohort study
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Gili Regev-Yochay, Yaniv Lustig, Gili Joseph, Mayan Gilboa, Noam Barda, Ilana Gens, Victoria Indenbaum, Osnat Halpern, Shiri Katz-Likvornik, Tal Levin, Yara Kanaaneh, Keren Asraf, Sharon Amit, Carmit Rubin, Arnona Ziv, Ravit Koren, Michal Mandelboim, Noam H Tokayer, Lilac Meltzer, Ram Doolman, Ella Mendelson, Sharon Alroy-Preis, and Yitshak Kreiss
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Microbiology (medical) ,Infectious Diseases ,Virology ,Microbiology - Published
- 2023
15. Humoral Immunity of Unvaccinated COVID-19 Recovered vs. Naïve BNT162b2 Vaccinated Individuals: A Prospective Longitudinal Study
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Regev-Yochay, Gili Joseph, Carmit Cohen, Carmit Rubin, Havi Murad, Victoria Indenbaum, Keren Asraf, Yael Weiss-Ottolenghi, Gabriella Segal-Lieberman, Yitshak Kreiss, Yaniv Lustig, and Gili
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immunoglobulin G ,antibodies ,neutralizing ,immunity ,humoral ,COVID-19 ,infection ,BNT162b2 vaccine - Abstract
To study the differences in the immune response to SARS-CoV-2 infection compared to the response to vaccination, we characterized the humoral immune kinetics of these situations. In this prospective longitudinal study, we followed unvaccinated COVID-19-recovered individuals (n = 130) and naïve, two-dose BNT162b2-vaccinated individuals (n = 372) who were age- and BMI-matched for six months during the first pandemic year. Anti-RBD-IgG, neutralizing antibodies (NAbs), and avidity were assessed monthly. For recovered patients, data on symptoms and the severity of the disease were collected. Anti-RBD-IgG and NAbs titers at peak were higher after vaccination vs. after infection, but the decline was steeper (peak log IgG: 3.08 vs. 1.81, peak log NAbs: 5.93 vs. 5.04, slopes: −0.54 vs. −0.26). Peak anti-RBD-IgG and NAbs were higher in recovered individuals with BMI > 30 and in older individuals compared to individuals with BMI < 30, younger population. Of the recovered, 42 (36%) experienced long-COVID symptoms. Avidity was initially higher in vaccinated individuals compared with recovered individuals, though with time, it increased in recovered individuals but not among vaccinated individuals. Here, we show that while the initial antibody titers, neutralization, and avidity are lower in SARS-CoV-2-recovered individuals, they persist for a longer duration. These results suggest differential protection against COVID-19 in recovered-unvaccinated vs. naïve-vaccinated individuals.
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- 2023
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16. Rapid Antigen Tests For Safe School Opening in the COVID-19 Pandemic Era
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Miki Goldenfeld, Carmit Cohen, Mayan Gilboa, Itai M. Pessach, Bella Mehnick, Ilana Tal, Lilac Meltzer, Sharon Amit, Tal Gonen, Arnon Afek, Yitshak Kreiss, and Gili Regev-Yochay
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Microbiology (medical) ,COVID-19 Testing ,Schools ,Infectious Diseases ,SARS-CoV-2 ,Pediatrics, Perinatology and Child Health ,COVID-19 ,Humans ,Pandemics - Abstract
Since the beginning of the Sever Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic, school closure as a mitigating measure was at the center of a public and professional debate. While the negative effects of school closure cannot be ignored, accumulating data suggested that it is necessary for reducing community transmission. Our study presents an optional strategy for safe school opening during a pandemic, implemented in selected Israeli high schools by a special task force constructed by the Sheba Medical Center (SMC).The study took place between November 2020 and April 2021. Three schools from different areas of Israel were enrolled. The participants were asked to undergo bi-weekly SARS-CoV-2 rapid diagnostic antigen tests (Ag-RDT). Those who tested positive were requested to self-isolate, whereas their school contacts were tested daily by Ag-RDT. Participants with a previously documented SARS-CoV-2 infection or who were found to be SARS-CoV-2 seropositive upon enrollment were exempted from screening.Of a total of 361 participants who enrolled in the study, 12.3% were found to be seropositive. Fourteen SARS-CoV-2 cases were detected (3.5%), 12 of them in one single school located in an endemic area for SARS-CoV-2. The 14 cases resulted in 84 days of COVID-19-related absence from school, comparing with 1775 potential days of COVID-19-related absence under a strategy implementing self-isolation instead of testing.Safe continuation of academic routine during the pandemic is possible when using rapid Ag-RDT as a screening tool, while allowing swab collection by trained students and teachers.
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- 2022
17. Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up
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Noam Barda, Yaniv Lustig, Victoria Indenbaum, Daniel Zibly, Gili Joseph, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Limor Kliker, Bayan Abd Elkader, Eytan Ben-Ami, Michal Canetti, Ravit Koren, Shiri Katz-Likvornik, Osnat Halpern, Ella Mendelson, Ram Doolman, Dror Harats, Yitshak Kreiss, Michal Mandelboim, and Gili Regev-Yochay
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Microbiology (medical) ,Infectious Diseases ,General Medicine - Published
- 2023
18. Early Immunogenicity and Safety of the Third Dose of BNT162b2 Messenger RNA Coronavirus Disease 2019 Vaccine Among Adults Older Than 60 Years: Real-World Experience
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Ital Nemet, Gili Regev-Yochay, Victoria Indenbaum, Ella Mendelson, Yitshak Kreiss, Limor Kliker, Carmit Cohen, Erez Bar-Haim, Mayan Gilboa, Ram Doolman, Sharon Amit, Carmit Rubin, Galia Rahav, Hanaa Jaber, Yaniv Lustig, Keren Asraf, and Michal Mandelboim
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Male ,COVID-19 Vaccines ,Health Personnel ,T cell ,Antibodies, Viral ,Neutralization ,Immunogenicity, Vaccine ,Immune system ,medicine ,Humans ,Immunology and Allergy ,RNA, Messenger ,Neutralizing antibody ,BNT162 Vaccine ,Aged ,Aged, 80 and over ,Messenger RNA ,biology ,SARS-CoV-2 ,business.industry ,Immunogenicity ,Age Factors ,COVID-19 ,Middle Aged ,Antibodies, Neutralizing ,Titer ,Infectious Diseases ,medicine.anatomical_structure ,Immunoglobulin G ,Immunology ,biology.protein ,Female ,Antibody ,business - Abstract
Background Despite high vaccine coverage, an increase in breakthrough coronavirus disease 2019 (COVID-19) infections, prompted administration of a third BNT162b2 dose to people aged >60 years in Israel since July 2021. Here, we report real-world immunogenicity following third dose. Methods Overall, 208 healthcare workers aged >60 years were included. Paired pre– and post–second and/or third dose immunoglobulin G (IgG) and neutralizing antibody titers were compared. A subpopulation of low responders to the second dose was also tested for T-cell activation. For 25 paired serum samples, we tested neutralization of wild-type vs neutralization of Delta and Lambda variants, pre– and post–third dose. Active surveillance of vaccine adverse events was conducted through surveys. Results A pronounced immune response was observed following the third dose, including a 33-fold and 51-fold increase in IgG and neutralizing antibody, respectively. The neutralizing antibody levels post–third dose were 9.34 times higher than post–second dose (geometric mean titer, 2598 [95% confidence interval {CI}, 2085–3237] vs 207 [95% CI, 126–339]). Nine previously low responders had a significant antibody increase post–third dose, and 7 of 9 showed increase in T-cell activation. Additionally, sera obtained post–third dose highly and comparably neutralized the wild-type and Delta and Lambda variants. Of 1056 responders to the adverse-event survey, none had serious events. Conclusions We demonstrate a rapid and broad immune response to the third BNT162b2 dose in individuals >60 years of age.
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- 2021
19. Six-Month Follow-up after a Fourth BNT162b2 Vaccine Dose
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Michal Canetti, Noam Barda, Mayan Gilboa, Victoria Indenbaum, Keren Asraf, Tal Gonen, Yael Weiss-Ottolenghi, Sharon Amit, Ram Doolman, Ella Mendelson, Laurence S. Freedman, Yitshak Kreiss, Yaniv Lustig, and Gili Regev-Yochay
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Immunization, Secondary ,Humans ,COVID-19 ,General Medicine ,Antibodies, Viral ,BNT162 Vaccine ,Follow-Up Studies - Published
- 2022
20. Omicron BA.2.75 variant is efficiently neutralised following BA.1 and BA.5 breakthrough infection in vaccinated individuals, Israel, June to September 2022
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Nofar, Atari, Limor, Kliker, Neta, Zuckerman, Bayan Abd, Elkader, Yael, Weiss-Ottolenghi, Ella, Mendelson, Yitshak, Kreiss, Gili, Regev-Yochay, and Michal, Mandelboim
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SARS-CoV-2 ,Epidemiology ,Virology ,Public Health, Environmental and Occupational Health ,Humans ,COVID-19 ,Israel ,Antibodies, Viral ,Antibodies, Neutralizing - Abstract
We evaluated neutralising antibody titres against wild type (WT) SARS-CoV-2 and four Omicron variants (BA.1, BA.2, BA.5 and BA.2.75) in fully vaccinated (three doses of Comirnaty vaccine) healthcare workers (HCW) in Israel who had breakthrough BA.1/BA5 infections. Omicron breakthrough infections in vaccinated individuals resulted in increased neutralising antibodies against the WT and Omicron variants compared with vaccinated uninfected HCW. HCW who recovered from BA.1 or BA.5 infections showed similar neutralising antibodies levels against BA.2.75.
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- 2022
21. Covid-19 Breakthrough Infections in Vaccinated Health Care Workers
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Gili Regev-Yochay, Victoria Indenbaum, Carmit Rubin, Adina Bar-Chaim, Yaniv Lustig, Michal Mandelboim, Einav G Levin, Moriah Bergwerk, Neta S. Zuckerman, Tal Gonen, Sharon Amit, Yitshak Kreiss, Marc Lipsitch, Malka Zavitan, Carmit Cohen, and Ilana Tal
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Adult ,Male ,medicine.medical_specialty ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Health Personnel ,viruses ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,MEDLINE ,Treatment failure ,Internal medicine ,Health care ,Humans ,Medicine ,RNA, Messenger ,Treatment Failure ,Israel ,BNT162 Vaccine ,Asymptomatic Diseases ,SARS-CoV-2 ,Reverse Transcriptase Polymerase Chain Reaction ,business.industry ,Extramural ,Case-control study ,COVID-19 ,virus diseases ,General Medicine ,Middle Aged ,Myocarditis ,COVID-19 Nucleic Acid Testing ,Case-Control Studies ,Original Article ,Female ,business - Abstract
Background Despite the high efficacy of the BNT162b2 messenger RNA vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rare breakthrough infections have been reported, including infections among health care workers. Data are needed to characterize these infections and define correlates of breakthrough and infectivity. Methods At the largest medical center in Israel, we identified breakthrough infections by performing extensive evaluations of health care workers who were symptomatic (including mild symptoms) or had known infection exposure. These evaluations included epidemiologic investigations, repeat reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assays, antigen-detecting rapid diagnostic testing (Ag-RDT), serologic assays, and genomic sequencing. Correlates of breakthrough infection were assessed in a case–control analysis. We matched patients with breakthrough infection who had antibody titers obtained within a week before SARS-CoV-2 detection (peri-infection period) with four to five uninfected controls and used generalized estimating equations to predict the geometric mean titers among cases and controls and the ratio between the titers in the two groups. We also assessed the correlation between neutralizing antibody titers and N gene cycle threshold (Ct) values with respect to infectivity. Results Among 1497 fully vaccinated health care workers for whom RT-PCR data were available, 39 SARS-CoV-2 breakthrough infections were documented. Neutralizing antibody titers in case patients during the peri-infection period were lower than those in matched uninfected controls (case-to-control ratio, 0.361; 95% confidence interval, 0.165 to 0.787). Higher peri-infection neutralizing antibody titers were associated with lower infectivity (higher Ct values). Most breakthrough cases were mild or asymptomatic, although 19% had persistent symptoms (>6 weeks). The B.1.1.7 (alpha) variant was found in 85% of samples tested. A total of 74% of case patients had a high viral load (Ct value
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- 2021
22. The National Israeli Field Hospital in Ukraine: Innovative adaptation to a unique scenario
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Elhanan Bar-On, Asaf Vivante, David Dagan, Yoel Har Even, Galia Barkai, Ariel Furer, Michael Bass, Michal Kirshenbaum, Omer Niv, Leonid Barski, Adam Lee Goldstein, Rami Sagi, Danny Moshayov, Shani Brosh, Michal Mekel, Eldad Katorza, and Yitshak Kreiss
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Health Policy ,Public Health, Environmental and Occupational Health ,Humans ,Israel ,Ukraine ,Delivery of Health Care ,Mobile Health Units - Published
- 2022
23. Comparing immunogenicity and efficacy of two different mRNA-based COVID-19 vaccines as a fourth dose; six-month follow-up, Israel, 27 December 2021 to 24 July 2022
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Noam Barda, Michal Canetti, Mayan Gilboa, Victoria Indenboim, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Daniel Zibly, Ram Doolman, Ella Mendelson, Dror Harats, Laurence S. Freedman, Yitshak Kreiss, Yaniv Lustig, and Gili Regev-Yochay
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COVID-19 Vaccines ,Epidemiology ,SARS-CoV-2 ,Virology ,Immunoglobulin G ,Public Health, Environmental and Occupational Health ,COVID-19 ,Humans ,RNA, Messenger ,Israel ,Follow-Up Studies - Abstract
We assess the immunogenicity and efficacy of Spikevax and Comirnaty as fourth dose COVID-19 vaccines. Six months post-fourth-dose, IgG levels were higher than pre-fourth dose at 1.58-fold (95% CI: 1.27–1.97) in Spikevax and 1.16-fold (95% CI: 0.98–1.37) in Comirnaty vaccinees. Nearly 60% (159/274) of vaccinees contracted SARS-CoV-2. Infection hazard ratios (HRs) for Spikevax (0.82; 95% CI: 0.62–1.09) and Comirnaty (0.86; 95% CI: 0.65–1.13) vaccinees were similar, as were substantial-disease HRs, i.e. 0.28 (95% CI: 0.13–0.62) and 0.51 (95% CI: 0.27–0.96), respectively.
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- 2022
24. Durability of Immune Response After COVID-19 Booster Vaccination and Association With COVID-19 Omicron Infection
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Mayan Gilboa, Gili Regev-Yochay, Michal Mandelboim, Victoria Indenbaum, Keren Asraf, Ronen Fluss, Sharon Amit, Ella Mendelson, Ram Doolman, Arnon Afek, Laurence S. Freedman, Yitshak Kreiss, and Yaniv Lustig
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Adult ,Male ,SARS-CoV-2 ,Vaccination ,Immunity ,COVID-19 ,RNA-Directed DNA Polymerase ,General Medicine ,Middle Aged ,Antibodies, Viral ,Antibodies, Neutralizing ,Immunoglobulin G ,Leukocytes, Mononuclear ,Humans ,Female ,Longitudinal Studies ,Prospective Studies ,BNT162 Vaccine - Abstract
ImportanceThe BNT162b2 two-dose vaccine (BioNTech/Pfizer) has high effectiveness that wanes within several months. The third dose is effective in mounting a significant immune response, but its durability is unknown.ObjectiveTo compare antibody waning after second and third doses and estimate the association of antibody kinetics with susceptibility to infection with the Omicron variant of SARS-CoV-2.Design, Setting, and ParticipantsIn a prospective longitudinal cohort study in a tertiary medical center in Israel, health care workers who received the BNT162b2 vaccine were followed up monthly for IgG and neutralizing antibody levels. Linear mixed models were used to compare antibody titer waning of second and third doses and to assess whether antibody dynamics were associated with Omicron transmission. Avidity, T cell activation, and microneutralization of sera against different variants of concern were assessed for a subgroup.ExposureVaccination with a booster dose of the BNT162b2 vaccine.Main Outcomes and MeasuresThe primary outcome was the rate of antibody titer change over time, and the secondary outcome was SARS-CoV-2 Omicron variant infection, as confirmed by reverse transcriptase–polymerase chain reaction.ResultsOverall, 4868 health care workers (mean [SD] age, 46.9 [13.7] years; 3558 [73.1%] women) and 3972 health care workers (mean [SD] age, 48.5 [14.1] years; 996 [74.9%] women) were followed up for 5 months after their second and third vaccine doses, respectively. Waning of IgG levels was slower after the third compared with the second dose (1.32%/d [95% CI, 1,29%/d to 1.36%/d] vs 2.26% [95% CI, 2.13%/d 2.38%/d]), as was waning of neutralizing antibody levels (1.32%/d [95% CI, 1.21%/d to 1.43%/d] vs 3.34%/d [95% CI, 3.11%/d to 3.58%/d]). Among 2865 health care workers assessed for Omicron incidence during an additional 2 months of follow-up, lower IgG peak (ratio of means 0.86 [95% CI, 0.80-0.91]) was associated with Omicron infection, and among participants aged 65 years and older, faster waning of IgG and neutralizing antibodies (ratio of mean rates, 1.40; [95% CI, 1.13-1.68] and 3.58 [95% CI, 1.92-6.67], respectively) were associated with Omicron infection. No waning in IgG avidity was observed 112 days after the third dose. Live neutralization of Omicron was lower compared with previous strains, with a geometric mean titer at the peak of 111 (95% CI, 75-166), compared with 942 (95% CI, 585-1518) for WT, 410 (95% CI, 266-634) for Delta; it demonstrated similar waning to 26 (95% CI, 16-42) within 4 months. Among 77 participants tested for T cell activity, mean (SD) T cell activity decreased from 98 (5.4) T cells/106 peripheral blood mononuclear cells to 59 (9.3) T cells/106 peripheral blood mononuclear cells.Conclusions and RelevanceThis study found that the third vaccine dose was associated with greater durability than the second dose; however, Omicron was associated with greater resistance to neutralization than wild type and Delta variants of concern. Humoral response dynamics were associated with susceptibility to Omicron infection.
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- 2022
25. Immune Response and Clinical Outcomes of BNT162b2 and mRNA1273 Fourth Dose COVID-19 Vaccines; Three Months Follow-up
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Michal Canetti, Noam Barda, Mayan Gilboa, Victoria Indenbaum, Michal Mandelboim, Tal Gonen, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Ram Doolman, Ella Mendelson, Dror Harats, Laurence S Freedman, Yitshak Kreiss, Yaniv Lustig, and Gili Regev-Yochay
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mRNA ,booster ,BNT162b2 ,vaccine efficacy ,mRNA1273 ,immunogenicity ,COVID-19 vaccine ,fourth dose - Abstract
Booster doses for the ongoing COVID-19 pandemic are under consideration in many countries. We report a three-month follow-up of 700 participants in a fourth vaccine dose study, comparing BNT162b2 and mRNA1273, administered four months after a third BNT162b2 dose. Waning of the immune response was evident during follow-up, with an 11% (ß=0.89, 95% CI, 0.88–0.9) and 21% (ß=0.79, 95% CI, 0.76–0.82) multiplicative decay per week of IgG and neutralizing antibodies, respectively, in the mRNA1273 group, and of 14% (ß=0.86, 95% CI, 0.86–0.87) and 26% (ß=0.74, 95% CI, 0.72–0.76), respectively, in the BNT162b2 group. Direct neutralization of Omicron variants was low relative to ancestral strains. Cumulatively over the study period, both vaccines showed little efficacy against infection but were highly efficacious against substantial disease [89% [(IRR 0.11, 95% CI, 0.02–0.37) and 71% (IRR 0.29, 95% CI, 0.13–0.57) for mRNA1273 and BNT162b2, respectively]. These results are informative for further boosting policy-making.
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- 2022
26. Factors Associated With Protection From SARS-CoV-2 Omicron Variant Infection and Disease Among Vaccinated Health Care Workers in Israel
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Mayan Gilboa, Tal Gonen, Noam Barda, Shelly Cohn, Victoria Indenbaum, Yael Weiss-Ottolenghi, Sharon Amit, Keren Asraf, Gili Joseph, Tal Levin, Yara Kanaaneh, Alex Aydenzon, Michal Canetti, Laurence Freedman, Neta Zuckerman, Ella Mendelson, Ram Doolman, Yitshak Kreiss, Gili Regev-Yochay, and Yaniv Lustig
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General Medicine - Abstract
ImportanceA correlation between antibody levels and risk of infection has been demonstrated for the wild-type, Alpha, and Delta SARS-COV-2 variants. High rates of breakthrough infections by the Omicron variant emphasized the need to investigate whether the humoral response elicited by mRNA vaccines is also associated with reduced risk of Omicron infection and disease.ObjectiveTo investigate whether the high antibody levels in individuals who have received at least 3 doses of an mRNA vaccine are associated with reduced risk of Omicron infection and disease.Design, Setting, and ParticipantsThis prospective cohort study used serial real time–polymerase chain reaction (RT-PCR) and serological test data from January and May 2022 to assess the association of preinfection immunoglobin G (IgG) and neutralizing antibody titers with incidence of Omicron variant infection, incidence of symptomatic disease, and infectivity. Participants included health care workers who had received 3 or 4 doses of an mRNA COVID-19 vaccine. Data were analyzed from May to August 2022.ExposuresLevels of SARS-CoV-2 anti–receptor binding domain IgG and neutralizing antibodies.Main Outcomes and MeasuresThe main outcomes were incidence of Omicron infection, incidence of symptomatic disease, and infectivity. Outcomes were measured using SARS-COV-2 PCR and antigen testing and daily online surveys regarding symptomatic disease.ResultsThis study included 3 cohorts for 3 different analyses: 2310 participants were included in the protection from infection analysis (4689 exposure events; median [IQR] age, 50 [40-60] years; 3590 [76.6%] among female health care workers), 667 participants (median [IQR] age, 46.28 (37.44,54.8); 516 [77.4%] female) in the symptomatic disease analysis, and 532 participants (median [IQR] age, 48 [39-56] years; 403 [75.8%] female) in the infectivity analysis. Lower odds of infection were observed for each 10-fold increase in preinfection IgG (odds ratio [OR], 0.71; 95% CI, 0.56-0.90) and for each 2-fold increase in neutralizing antibody titers (OR, 0.89; 95% CI, 0.83-0.95). The odds of substantial symptomatic disease were reduced for each 10-fold increase in IgG levels (OR, 0.48; 95% CI, 0.29-0.78) and for each 2-fold increase in neutralizing antibodies levels (OR, 0.86; 95% CI, 0.76-0.96). Infectivity, assessed by mean cycle threshold value, was not significantly decreased with increasing IgG or neutralizing antibodies titers.Conclusions and RelevanceIn this cohort study of vaccinated health care workers, IgG and neutralizing antibody titer levels were associated with protection against infection with the Omicron variant and against symptomatic disease.
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- 2023
27. COVID-19 vaccination and BA.1 breakthrough infection induce neutralising antibodies which are less efficient against BA.4 and BA.5 Omicron variants, Israel, March to June 2022
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Limor, Kliker, Neta, Zuckerman, Nofar, Atari, Noam, Barda, Mayan, Gilboa, Ital, Nemet, Bayan, Abd Elkader, Ilana S, Fratty, Hanaa, Jaber, Ella, Mendelson, Sharon, Alroy-Preis, Yitshak, Kreiss, Gili, Regev-Yochay, and Michal, Mandelboim
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Vaccines ,COVID-19 Vaccines ,SARS-CoV-2 ,Epidemiology ,Virology ,Vaccination ,Public Health, Environmental and Occupational Health ,COVID-19 ,Humans ,Israel ,Antibodies, Viral ,Antibodies, Neutralizing - Abstract
This work evaluated neutralising antibody titres against wild type (WT) SARS-CoV-2 and four Omicron variants (BA.1, BA.2, BA.4 and BA.5) in healthcare workers who had breakthrough BA.1 infection. Omicron breakthrough infection in individuals vaccinated three or four times before infection resulted in increased neutralising antibodies against the WT virus. The fourth vaccine dose did not further improve the neutralising efficiency over the third dose against all Omicron variants, especially BA.4 and BA.5. An Omicron-specific vaccine may be indicated.
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- 2022
28. Establishing a COVID-19 treatment centre in Israel at the initial stage of the outbreak: challenges, responses and lessons learned
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Gili Regev-Yochay, Galia Barkai, Hindy Englard, Eldad Katorza, Asaf Biber, Arnon Afek, Gad Segal, Yitshak Kreiss, Amir Grinberg, Avinoah Irony, Elhanan Bar-On, Assaf Luttinger, and Galia Rahav
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Telemedicine ,disaster planning and response ,Coronavirus disease 2019 (COVID-19) ,global health ,infectious diseases ,Critical Care and Intensive Care Medicine ,Hospitals, Special ,Workflow ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,Israel ,Personal Protective Equipment ,Patient isolation ,Infection Control ,SARS-CoV-2 ,business.industry ,COVID-19 ,030208 emergency & critical care medicine ,General Medicine ,medicine.disease ,major incident ,Triage ,Referral centre ,Emergency Medicine ,Report from the Front ,Medical emergency ,planning ,Emergency Service, Hospital ,business ,Personal protection equipment ,viral - Abstract
Anticipating the need for a COVID-19 treatment centre in Israel, a designated facility was established at Sheba Medical Center—a quaternary referral centre. The goals were diagnosis and treatment of patients with COVID-19 while protecting patients and staff from infection and ensuring operational continuity and treatment of patients with non-COVID. Options considered included adaptation of existing wards, building a tented facility and converting a non-medical structure. The option chosen was a non-medical structure converted to a hospitalisation facility suited for COVID-19 with appropriate logistic and organisational adaptations. Operational principles included patient isolation, unidirectional workflow from clean to contaminated zones and minimising direct contact between patients and caregivers using personal protection equipment (PPE) and a multimodal telemedicine system. The ED was modified to enable triage and treatment of patients with COVID-19 while maintaining a COVID-19-free environment in the main campus. This system enabled treatment of patients with COVID-19 while maintaining staff safety and conserving the operational continuity and the ability to continue delivery of treatment to patients with non-COVID-19.
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- 2021
29. The association between witnessing patient death and mental health outcomes in frontline COVID‐19 healthcare workers
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Rony Cleper, Itai M. Pessach, Ilanit Hasson-Ohayon, Doron Gothelf, Nimrod Hertz-Palmor, Raz Gross, Yitshak Kreiss, Rachel Kaplan, and Mariela Mosheva
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medicine.medical_specialty ,Health Personnel ,Anxiety ,stress ,03 medical and health sciences ,0302 clinical medicine ,COVID‐19 ,Outcome Assessment, Health Care ,Health care ,medicine ,Humans ,Israel ,Risk factor ,Psychiatry ,Research Articles ,Depression (differential diagnoses) ,Depression ,SARS-CoV-2 ,business.industry ,Traumatic stress ,COVID-19 ,PTSD ,Odds ratio ,Mental health ,Confidence interval ,030227 psychiatry ,Psychiatry and Mental health ,Clinical Psychology ,Cross-Sectional Studies ,medicine.symptom ,business ,mental health ,030217 neurology & neurosurgery ,Research Article - Abstract
Background Healthcare workers (HCW) treating coronavirus disease 2019 (COVID‐19) patients face high levels of psychological stress. We aimed to compare mental health outcomes, risk and protective factors for posttraumatic stress symptoms (PTSS), probable depression, and anxiety between HCW working in COVID‐19 and non‐COVID‐19 wards. Methods A self‐report survey, administered in a large tertiary hospital in Israel during the peak of the COVID‐19 outbreak was completed by 828 HCW (42.2% physicians, 57.8% nurses. Patient‐Reported Outcomes Measurement Information System; the Patient Health Questionnaire‐9; the Primary Care‐Post Traumatic Stress Disorder Screen for DSM‐5 (PC‐PTSD‐5) were used for assessing anxiety, depression, and PTSS, respectively. Pandemic‐related stress factors, negative experiences, and potential protective factors were also assessed. Results Median PC‐PTSD scores differed significantly between study teams (χ 2 [5] = 17.24; p = .004). Prevalence of probable depression and anxiety were similar in both groups. Risk factors for mental health outcomes included mental exhaustion, anxiety about being infected and infecting family. Overall, higher proportion of the COVID‐19 team witnessed patient deaths as compared to the non‐COVID‐19 team (50.2% vs. 24.7%). Witnessing patient death at the COVID‐19 wards was associated with a four‐fold increased likelihood of PTSS (odds ratio [OR] = 3.97; 95% confidence interval [CI], 1.58–9.99; p = .0007), compared with the non‐COVID‐19 wards (OR 0.91; 95% CI, 0.51–1.61; p = .43). Conclusions Witnessing patient death appears to be a risk factor for PTSS unique to HCW directly engaged in treating patients with COVID‐19. Our findings suggest that helping HCW cope with COVID‐19 related deaths might reduce their risk of posttraumatic stress.
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- 2021
30. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron
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Gili Regev-Yochay, Tal Gonen, Mayan Gilboa, Michal Mandelboim, Victoria Indenbaum, Sharon Amit, Lilac Meltzer, Keren Asraf, Carmit Cohen, Ronen Fluss, Asaf Biber, Ital Nemet, Limor Kliker, Gili Joseph, Ram Doolman, Ella Mendelson, Laurence S. Freedman, Dror Harats, Yitshak Kreiss, and Yaniv Lustig
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Vaccines, Synthetic ,COVID-19 Vaccines ,SARS-CoV-2 ,Immunization, Secondary ,COVID-19 ,Humans ,Vaccine Efficacy ,General Medicine ,mRNA Vaccines - Published
- 2022
31. Real World Performance of SARS-CoV-2 Antigen Rapid Diagnostic Tests in Various Clinical Settings
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Gili Regev-Yochay, Or Kriger, Michael J. Mina, Sharon Beni, Carmit Rubin, Bella Mechnik, Sabrina Hason, Elad Biber, Bian Nadaf, Yitshak Kreiss, and Sharon Amit
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Microbiology (medical) ,Infectious Diseases ,Epidemiology - Abstract
Objective: To assess the validity of Antigen rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 as decision support tool in various hospital-based clinical settings. Design: Retrospective cohort study among symptomatic and asymptomatic patients and Healthcare workers (HCW). Setting: A large tertiary teaching medical center serving as a major COVID-19 hospitalizing facility. Participants and Methods: Ag-RDTs’ performance was assessed in three clinical settings: 1. Symptomatic patients and HCW presenting at the Emergency Departments 2. Asymptomatic patients screened upon hospitalization 3. HCW of all sectors tested at the HCW clinic following exposure. Results: We obtained 5172 samples from 4595 individuals, who had both Ag-RDT and quantitative real-time PCR (qRT-PCR) results available. Of these, 485 samples were positive by qRT-PCR. The positive percent agreement (PPA) of Ag-RDT was greater for lower cycle threshold (Ct) values, reaching 93% in cases where Ct-value was Conclusions: Ag-RDT are highly sensitive to the infectious stage of COVID-19 manifested by either high viral load (lower Ct) or proximity to infection, whether patient is symptomatic or asymptomatic. Thus, this simple-to-use and inexpensive detection method can be used as a decision support tool in various in-hospital clinical settings, assisting patient flow and maintaining sufficient hospital staffing.
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- 2022
32. 4th Dose COVID mRNA Vaccines’ Immunogenicity & Efficacy Against Omicron VOC
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Gili Regev-Yochay, Tal Gonen, Mayan Gilboa, Michal Mandelboim, Victoria Indenbaum, Sharon Amit, Lilac Meltzer, Keren Asraf, Carmit Cohen, Ronen Fluss, Asaf Biber, Ital Nemet, Limor Kliker, Gili Joseph, Ram Doolman, Ella Mendelson, Laurence S. Freedman, Dror Harats, Yitshak Kreiss, and Yaniv Lustig
- Abstract
BACKGROUNDFollowing the emergence of the Omicron variant of concern, we investigated immunogenicity, efficacy and safety of BNT162b2 or mRNA1273 fourth dose in an open-label, clinical intervention trial.METHODSPrimary end-points were safety and immunogenicity and secondary end-points were vaccine efficacy in preventing SARS-CoV-2 infections and COVID-19 symptomatic disease. The two intervention arms were compared to a matched control group. Eligible participants were healthcare-workers (HCW) vaccinated with three BNT162b2 doses, and whose IgG antibody levels were ≤700 BAU (40-percentile). IgG and neutralizing titers, direct neutralization of live VOCs, and T-cell activation were assessed. All participants were actively screened for SARS-CoV-2 infections on a weekly basis.RESULTSOf 1050 eligible HCW, 154 and 120 were enrolled to receive BNT162b2 and mRNA1273, respectively, and compared to 426 age-matched controls. Recipients of both vaccine types had a ∼9-10-fold increase in IgG and neutralizing titers within 2 weeks of vaccination and an 8-fold increase in live Omicron VOC neutralization, restoring titers to those measured after the third vaccine dose. Breakthrough infections were common, mostly very mild, yet, with high viral loads. Vaccine efficacy against infection was 30% (95%CI:-9% to 55%) and 11% (95%CI:-43% to +43%) for BNT162b2 and mRNA1273, respectively. Local and systemic adverse reactions were reported in 80% and 40%, respectively.CONCLUSIONSThe fourth COVID-19 mRNA dose restores antibody titers to peak post-third dose titers. Low efficacy in preventing mild or asymptomatic Omicron infections and the infectious potential of breakthrough cases raise the urgency of next generation vaccine development.Trial registration numberclicaltrials.gov: NCT05231005, NCT05230953
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- 2022
33. Superior immunogenicity and effectiveness of the third compared to the second BNT162b2 vaccine dose
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Yaniv Lustig, Tal Gonen, Lilac Meltzer, Mayan Gilboa, Victoria Indenbaum, Carmit Cohen, Sharon Amit, Hanaa Jaber, Ram Doolman, Keren Asraf, Carmit Rubin, Ronen Fluss, Ella Mendelson, Laurence Freedman, Gili Regev-Yochay, and Yitshak Kreiss
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Vaccines ,COVID-19 Vaccines ,Immunogenicity, Vaccine ,SARS-CoV-2 ,Immunoglobulin G ,Immunology ,Immunology and Allergy ,COVID-19 ,Humans ,Prospective Studies ,Antibodies, Viral ,BNT162 Vaccine - Abstract
As the effectiveness of a two-dose messenger RNA (mRNA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine regimen decreases with time, a third dose has been recommended. Here, we assessed immunogenicity, vaccine effectiveness and safety of the third BNT162b2 vaccine dose in a prospective cohort study of 12,413 healthcare workers (HCWs). Anti-RBD immunoglobulin G (IgG) levels were increased 1.7-fold after a third dose compared with following the second dose. Increased avidity from 61.1% (95% confidence interval (CI), 56.1-66.7) to 96.3% (95% CI, 94.2-98.5) resulted in a 6.1-fold increase in neutralization titer. Peri-infection humoral markers of 13 third-dose Delta variant of concern (VOC) breakthrough cases were lower compared with 52 matched controls. Vaccine effectiveness of the third dose relative to two doses was 85.6% (95% CI, 79.2-90.1). No serious adverse effects were reported. These results suggest that the third dose is superior to the second dose in both quantity and quality of IgG antibodies and safely boosts protection from infection.
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- 2022
34. Application of information technology within a field hospital deployment following the January 2010 Haiti earthquake disaster.
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Gad Levy, Nehemia Blumberg, Yitshak Kreiss, Nachman Ash, and Ofer Merin
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- 2010
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35. Kinetics of cellular and humoral responses to third BNT162B2 COVID-19 vaccine over six months in heart transplant recipients - implications for the omicron variant
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Yael Peled, Arnon Afek, Yitshak Kreiss, Galia Rahav, Ital Nemet, Limor Kliker, Victoria Indenbaum, Eilon Ram, Jacob Lavee, Amit Segev, Shlomi Matezki, Leonid Sternik, Ehud Raanani, Yaniv Lustig, Jignesh K. Patel, and Michal Mandelboim
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Pulmonary and Respiratory Medicine ,AIDS Vaccines ,Transplantation ,Mice, Inbred BALB C ,COVID-19 Vaccines ,SARS-CoV-2 ,SAIDS Vaccines ,COVID-19 ,Antibodies, Viral ,Mice ,Influenza Vaccines ,BCG Vaccine ,Respiratory Syncytial Virus Vaccines ,Animals ,Heart Transplantation ,Humans ,Surgery ,Papillomavirus Vaccines ,Cardiology and Cardiovascular Medicine ,BNT162 Vaccine ,Diphtheria-Tetanus-Pertussis Vaccine ,Measles-Mumps-Rubella Vaccine - Abstract
The durability of the immune response following the 3-dose BNT162b2 vaccination is unknown. The complexity of the situation is enhanced by the threat that highly transmissible variants may further accelerate the decline in the protection afforded by mRNA vaccines.One hundred and three 3-dose-vaccinated heart transplant recipients were longitudinally assessed for the kinetics of variant-specific neutralization (Cohort 1, n = 60) and SARS-CoV-2-specific-T-cell response (Cohort 2, n = 54) over 6 months. Neutralization and T-cell responses were compared between paired samples at 2 time points, using the Kruskal-Wallis test followed by Dunn's multiple comparison test for continuous variables and McNemar's test for dichotomous variables. The Bonferroni method of p values adjustment for multiple comparison was applied.The third dose induced high neutralization of the wild-type virus and delta variant (geometric mean titer [GMT], 137.2 [95% CI, 84.8-221.9] and 80.6, [95% CI, 49.3-132.0], respectively), and to a lesser degree of the omicron variant (GMT, 10.3 [95% CI, 5.9-17.9]). At 6 months, serum neutralizing activity declined but was still high for the wild-type virus and for the delta variant (GMTs 38.1 [95% CI, 21.2-69.4], p = 0.011; and 28.9 [95% CI, 16.6-52.3], p = 0.022, respectively), but not for the omicron variant (GMT 5.9 [95% CI, 3.4-9.8], p = 0.463). The percentages of neutralizing sera against the wild-type virus, delta and omicron variants increased from 70%, 65%, and 38%, before the third dose, to 93% (p0.001), 88% (p0.001), and 48% (p = 0.021) at 3 weeks after, respectively; and remained high through the 6 months for the wild-type (80%, p = 0.06) and delta (77%, p = 0.102). The third dose induced the development of a sustained SARS-CoV-2-specific-T-cell population, which persisted through 6 months.The third BNT162b2 dose elicited a durable SARS-CoV-2-specific T-cell response and induced effective and durable neutralization of the wild-type virus and the delta variant, and to a lesser degree of the omicron variant.
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- 2022
36. Correlates of Protection of BNT162b2 Against COVID-19 Infection and Intensity of Symptomatic Disease; the Israeli COVID-19 Family Study (ICoFS)
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Gili Regev-Yochay, Yaniv Lustig, Gili Joseph, Mayan Gilboa, Noam Barda, Ilana Gens, Victoria Indenbaum, Osnat Halpern, Shiri Katz-Likvornik, Tal Levin, Yara Kanaaneh, Keren Asraf, Sharon Amit, Carmit Rubin, Arnona Ziv, Ravit Koren, Michal Mandelboim, Noam H. Tokayer, Lilac Meltzer, Ram Doolman, Ella Mendelson, Sharon Alroy-Preis, and Yitshak Kreiss
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- 2022
37. Third BNT162b2 Vaccination Neutralization of SARS-CoV-2 Omicron Infection
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Ital Nemet, Limor Kliker, Yaniv Lustig, Neta S. Zuckerman, Oran Erster, Carmit Cohen, Yitshak Kreiss, Sharon Alroy-Preis, Gili Regev-Yochay, Ella Mendelson, and Michal Mandelboim
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COVID-19 Vaccines ,SARS-CoV-2 ,Immunization, Secondary ,COVID-19 ,Humans ,Vaccine Efficacy ,General Medicine ,Antibodies, Neutralizing ,BNT162 Vaccine - Abstract
Using isolates of SARS-CoV-2 WT, Beta, Delta and most importantly Omicron we studied the capability of the BNT162b2 vaccine given in two or three doses to neutralize major SARS-CoV-2 variants of concern (VOC).We demonstrate low neutralization efficiency against delta and wild-type for vaccines with more than 5 months following the second BNT162b2 dose, with no neutralization efficiency against Omicron. We demonstrate the importance of a third dose, by showing a 100-fold increase in neutralization efficiency of Omicron following a third dose, with a 4-fold reduced neutralization compared to that against the Delta VOC. The durability of the effect of the third dose is yet to be determined.
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- 2021
38. Superior immunogenicity and effectiveness of the 3rd BNT162b2 vaccine dose
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Yaniv Lustig, Tal Gonen, Lilac Melzer, Mayan Gilboa, Victoria Indenbaum, Carmit Cohen, Sharon Amit, Hanaa Jaber, Ram Doolman, Keren Asraf, Carmit Rubin, Ronen Fluss, Ella Mendelson, Laurence Freedman, Gili Regev-Yochay, and Yitshak Kreiss
- Abstract
In a prospective cohort study involving 12,413 Health Care Workers (HCW), we assessed immunogenicity, vaccine-effectiveness (VE) and safety of the third BNT162b2 vaccine dose. One month after third dose, anti-RBD-IgG were induced 1.7-folds compared to one month after the second. A significant increase in avidity from 61.1% (95%CI:56.1-66.7) to 96.3% (95%CI:94.2-98.5) resulted in a 6.1-folds neutralizing antibodies induction. Linear mixed model demonstrated that the third dose elicited a greater response among HCW≥60 or those with ≥two comorbidities who had a lower response following the second dose. VE of the third dose relative to two doses was 85.6% (95% CI, 79.2-90.1%). No serious adverse effects were reported. These results suggest that the third dose is superior to the second dose in both quantity and quality of IgG-antibodies and safely boosts protection from SARS-CoV-2 infection by generating high avidity antibodies to levels that are not significantly different between healthy and vulnerable populations.
- Published
- 2021
39. Sleep Difficulties Among COVID-19 Frontline Healthcare Workers
- Author
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Rony Cleper, Nimrod Hertz-Palmor, Mariela Mosheva, Ilanit Hasson-Ohayon, Rachel Kaplan, Yitshak Kreiss, Arnon Afek, Itai M. Pessach, Doron Gothelf, and Raz Gross
- Subjects
Psychiatry and Mental health - Abstract
ObjectiveTo identify COVID-19 work-related stressors and experiences associated with sleep difficulties in HCW, and to assess the role of depression and traumatic stress in this association.MethodsA cross-sectional study of HCW using self-report questionnaires, during the first peak of the pandemic in Israel (April 2020), conducted in a large tertiary medical center in Israel. Study population included 189 physicians and nurses working in designated COVID-19 wards and a comparison group of 643 HCW. Mean age of the total sample was 41.7 ± 11.1, 67% were female, 42.1% physicians, with overall mean number of years of professional experience 14.2 ± 20. The exposure was working in COVID-19 wards and related specific stressors and negative experiences. Primary outcome measurement was the Insomnia Severity Index (ISI). Secondary outcomes included the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5); the Patient Health Questionnaire-9 (PHQ-9) for depression; the anxiety module of the Patient-Reported Outcomes Measurement Information System (PROMIS); Pandemic-Related Stress Factors (PRSF) and witnessing patient suffering and death.ResultsCompared with non-COVID-19 HCW, COVID-19 HCW were more likely to be male (41.3% vs. 30.7%) and younger (36.91 ± 8.81 vs. 43.14 ± 11.35 years). COVID-19 HCW reported higher prevalence of sleep difficulties: 63% vs. 50.7% in the non-COVID group (OR 1.62, 95% CI 1.15–2.29, p = 0.006), mostly difficulty maintaining sleep: 26.5% vs. 18.5% (OR 1.65, 95% CI 1.11–2.44, p = 0.012). Negative COVID-19 work-related experiences, specifically witnessing patient physical suffering and death, partially explained the association. Although past psychological problems and current depression and PTSD were associated with difficulty maintaining sleep, the main association remained robust also after controlling for those conditions in the full model.Conclusion and RelevanceCOVID-19 frontline HCW were more likely to report sleep difficulties, mainly difficulty maintaining sleep, as compared with non-COVID-19 HCW working at the same hospital. Negative patient-care related experiences likely mediated the increased probability for those difficulties. Future research is needed to elucidate the long-term trajectories of sleep difficulties among HCW during large scale outbreaks, and to identify risk factors for their persistence.
- Published
- 2021
40. Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients
- Author
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Yitshak Kreiss, Gili Regev-Yochay, Eyal Leshem, Arnon Afek, and Sharon Amit
- Subjects
medicine.medical_specialty ,2019-20 coronavirus outbreak ,Medical staff ,Coronavirus disease 2019 (COVID-19) ,Infectious disease transmission ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Retrospective cohort study ,General Medicine ,Virology ,Correspondence ,Pandemic ,Epidemiology ,medicine ,business - Published
- 2021
41. Third dose of the BNT162b2 vaccine in heart transplant recipients: Immunogenicity and clinical experience
- Author
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Leonid Sternik, Arnon Afek, Anat Wieder-Finesod, Shlomi Matezki, Yaniv Lustig, Amit Segev, Victoria Indenbaum, Galia Rahav, Michal Mandelboim, Ehud Raanani, Itzchak Levy, Jacob Lavee, Eilon Ram, Yitshak Kreiss, Yael Peled, and Rebecca Halperin
- Subjects
Pulmonary and Respiratory Medicine ,Male ,medicine.medical_treatment ,COVID-19 pandemic ,Booster dose ,Antibodies, Viral ,Drug Administration Schedule ,Cohort Studies ,Immune system ,Immunogenicity, Vaccine ,medicine ,Humans ,Adverse effect ,BNT162 Vaccine ,Aged ,Heart transplantation ,Transplantation ,BNT162b2 vaccine ,biology ,business.industry ,SARS-CoV-2 ,Immunogenicity ,COVID-19 ,Middle Aged ,Original Clinical Science ,Booster ,Hear transplantation ,Titer ,Tolerability ,Immunology ,Antibody Formation ,biology.protein ,Heart Transplantation ,Surgery ,Female ,Antibody ,Cardiology and Cardiovascular Medicine ,business - Abstract
BACKGROUND The repeated waves of the COVID-19 pandemic have highlighted the necessity to optimize vaccine responses in immunocompromised populations. We investigated the safety and immunogenicity of a third, booster, dose of the Pfizer BNT162b2 vaccine in heart transplant (HT) patients. METHODS The cohort comprised 96 adult HT patients who received a third homologous dose of the BNT162b2 vaccine 168 days after the second dose. The vaccine-induced antibody responses of both receptor-binding domain (RBD) IgG and neutralizing antibodies were assessed in all patients, with a positive antibody response being defined as the presence of either IgG anti-RBD or neutralizing antibodies. For a subset of patients, T cell response was also studied. RESULTS The third dose was associated with a low rate of adverse events, mostly mild pain at the injection site. No serious adverse events were recorded, and there were no episodes of rejection. At 18 days following the third dose of the vaccine, the positive antibody response increased from 23% to 67%, with a corresponding increase in neutralizing capacity. The third dose elicited SARS-CoV-2 neutralization titers >9-fold and IgG anti-RBD antibodies >3-fold of the range achieved after the two primary doses. Mycophenolate use, lower eGFR and higher C-reactive protein were independently associated with a reduced likelihood of generating an immune response. Importantly, a specific T-cell response following the third dose was evident in the majority of transplant recipients. CONCLUSIONS An homologous third booster dose of the BNT162b2 vaccine gave overall consistent tolerability and a good safety profile, while eliciting humoral and cellular immune responses.
- Published
- 2021
42. Decreased infectivity following BNT162b2 vaccination: A prospective cohort study in Israel
- Author
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Amit Huppert, Arnon Afek, Yaniv Lustig, Galia Rahav, Arnona Ziv, Sharon Amit, Eyal Leshem, Yitshak Kreiss, Carmit Rubin, Ilya Novikov, Ram Doolman, Rebecca Kahn, Gili Regev-Yochay, Moriah Bergwerk, Irena Gimpelevich, Carmit Cohen, and Marc Lipsitch
- Subjects
Infectivity ,medicine.medical_specialty ,business.industry ,Transmission (medicine) ,Health Policy ,Incidence (epidemiology) ,Asymptomatic ,Herd immunity ,Vaccination ,Oncology ,Internal medicine ,Internal Medicine ,medicine ,Viral shedding ,medicine.symptom ,Public aspects of medicine ,RA1-1270 ,Prospective cohort study ,business ,Research Paper - Abstract
Background: BNT162b2 was shown to be 92% effective in preventing COVID-19. Prioritizing vaccine rollout, and achievement of herd immunity depend on SARS-CoV-2 transmission reduction. The vaccine's effect on infectivity is thus a critical priority. Methods: Among all 9650 HCW of a large tertiary medical center in Israel, we calculated the prevalence of positive SARS-CoV-2 qRT-PCR cases with asymptomatic presentation, tested following known or presumed exposure and the infectious subset (N-gene-Ct-value
- Published
- 2021
43. Is Now the Time for the Fourth BNT162b2 Dose for Residents of Long-term Care Facilities?
- Author
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Galia Rahav, Nimrod Maimon, Rebeca Halperin, Ital Nemet, Yitshak Kreiss, Arnon Afek, and Michal Mandelboim
- Subjects
Aging ,Homes for the Aged ,Humans ,Geriatrics and Gerontology ,Long-Term Care ,BNT162 Vaccine ,Aged ,Nursing Homes ,Skilled Nursing Facilities - Published
- 2022
44. BNT162b2 COVID-19 vaccine and correlates of humoral immune responses and dynamics: a prospective, single-centre, longitudinal cohort study in health-care workers
- Author
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Laurence S. Freedman, Carmit Cohen, Amit Huppert, Sharon Amit, Liraz Olmer, Ram Doolman, Yitshak Kreiss, Gili Regev-Yochay, Ella Mendelson, Einav Sapir, Arnona Ziv, Victoria Indenbaum, Michal Mandelboim, Ronen Fluss, Carmit Rubin, and Yaniv Lustig
- Subjects
Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,COVID-19 Vaccines ,Adolescent ,Health Personnel ,medicine.medical_treatment ,Antibodies, Viral ,Serology ,Young Adult ,03 medical and health sciences ,Immunogenicity, Vaccine ,0302 clinical medicine ,Immunity ,Internal medicine ,medicine ,Humans ,Longitudinal Studies ,Prospective Studies ,030212 general & internal medicine ,Israel ,Young adult ,Prospective cohort study ,Pandemics ,BNT162 Vaccine ,Aged ,Aged, 80 and over ,biology ,SARS-CoV-2 ,business.industry ,Vaccination ,Comment ,COVID-19 ,Immunosuppression ,Articles ,Middle Aged ,Antibodies, Neutralizing ,Immunity, Humoral ,Policy ,030228 respiratory system ,biology.protein ,Population study ,Female ,Antibody ,business ,Follow-Up Studies - Abstract
Summary Background Concurrent with the Pfizer–BioNTech BNT162b2 COVID-19 vaccine roll-out in Israel initiated on Dec 19, 2020, we assessed the early antibody responses and antibody kinetics after each vaccine dose in health-care workers of different ages and sexes, and with different comorbidities. Methods We did a prospective, single-centre, longitudinal cohort study at the Sheba Medical Centre (Tel-Hashomer, Israel). Eligible participants were health-care workers at the centre who had a negative anti-SARS-CoV-2 IgG assay before receiving the first dose of the intramuscular vaccine, and at least one serological antibody test after the first dose of the vaccine. Health-care workers with a positive SARS-CoV-2 PCR test before vaccination, a positive anti-SARS-CoV-2 IgG serology test before vaccination, or infection with COVID-19 after vaccination were excluded from the study. Participants were followed up weekly for 5 weeks after the first vaccine dose; a second dose was given at week 3. Serum samples were obtained at baseline and at each weekly follow-up, and antibodies were tested at 1–2 weeks after the first vaccine dose, at week 3 with the administration of the second vaccine dose, and at weeks 4–5 (ie, 1–2 weeks after the second vaccine dose). Participants with comorbidities were approached to participate in an enriched comorbidities subgroup, and at least two neutralising assays were done during the 5 weeks of follow-up in those individuals. IgG assays were done for the entire study population, whereas IgM, IgA, and neutralising antibody assays were done only in the enriched comorbidities subgroup. Concentrations of IgG greater than 0·62 sample-to-cutoff (s/co) ratio and of IgA greater than 1·1 s/co, and titres of neutralising antibodies greater than 10 were considered positive. Scatter plot and correlation analyses, logistic and linear regression analyses, and linear mixed models were used to investigate the longitudinal antibody responses. Findings Between Dec 19, 2020, and Jan 30, 2021, we obtained 4026 serum samples from 2607 eligible, vaccinated participants. 342 individuals were included in the enriched comorbidities subgroup. The first vaccine dose elicited positive IgG and neutralising antibody responses at week 3 in 707 (88·0%) of 803 individuals, and 264 (71·0%) of 372 individuals, respectively, which were rapidly increased at week 4 (ie, 1 week after the second vaccine dose) in 1011 (98·4%) of 1027 and 357 (96·5%) of 370 individuals, respectively. Over 4 weeks of follow-up after vaccination, a high correlation (r=0·92) was detected between IgG against the receptor-binding domain and neutralising antibody titres. First-dose induced IgG response was significantly lower in individuals aged 66 years and older (ratio of means 0·25, 95% CI 0·19–0·31) and immunosuppressed individuals (0·21, 0·14–0·31) compared with individuals aged 18·00–45·99 years and individuals with no immunosuppression, respectively. This disparity was partly abrogated following the second dose. Overall, endpoint regression analysis showed that lower antibody concentrations were consistently associated with male sex (ratio of means 0·84, 95% CI 0·80–0·89), older age (ie, ≥66 years; 0·64, 0·58–0·71), immunosuppression (0·44, 0·33–0·58), and other specific comorbidities: diabetes (0·88, 0·79–0·98), hypertension (0·90, 0·82–0·98), heart disease (0·86, 0·75–1·00), and autoimmune diseases (0·82, 0·73–0·92). Interpretation BNT162b2 vaccine induces a robust and rapid antibody response. The significant correlation between receptor-binding domain IgG antibodies and neutralisation titres suggests that IgG antibodies might serve as a correlate of neutralisation. The second vaccine dose is particularly important for older and immunosuppressed individuals, highlighting the need for timely second vaccinations and potentially a revaluation of the long gap between doses in some countries. Antibody responses were reduced in susceptible populations and therefore they might be more prone to breakthrough infections. Funding Sheba Medical Center, Israel Ministry of Health.
- Published
- 2021
45. Remote ischemic preconditioning improves tissue oxygenation in a porcine model of controlled hemorrhage without fluid resuscitation
- Author
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Elon Glassberg, Daniel Rimbrot, Jacob Megreli, Baruch Batzofin, Linn Wagnert-Avraham, Arik Eisenkraft, Ben Simon, Gil Shimon, Matan Cohen, Yitshak Kreiss, Lilach Gavish, Amir Shlaifer, Shimon Firman, S. David Gertz, Asaf Berman, Ruth Shaylor, David Kushnir, Michael Hartal, Dean Nachman, Yuval Heled, and Gal Yaniv
- Subjects
Male ,Mean arterial pressure ,Resuscitation ,Swine ,Science ,medicine.medical_treatment ,Ischemia ,Hemodynamics ,Shock, Hemorrhagic ,030204 cardiovascular system & hematology ,Article ,03 medical and health sciences ,Medical research ,0302 clinical medicine ,Heart Rate ,medicine ,Animals ,Arterial Pressure ,Ischemic Preconditioning ,Signs and symptoms ,Multidisciplinary ,business.industry ,030208 emergency & critical care medicine ,Recovery of Function ,Blood flow ,medicine.disease ,Survival Analysis ,Oxygen ,Disease Models, Animal ,Shock (circulatory) ,Anesthesia ,Medicine ,Ischemic preconditioning ,Female ,medicine.symptom ,business ,Fluid replacement - Abstract
Purpose Remote Ischemic preconditioning (RIPC) involves deliberate, brief interruptions of blood flow to increase the tolerance of distant critical organs to ischemia. This study tests the effects of limb RIPC in a porcine model of controlled hemorrhage without replacement therapy simulating an extreme field situation of delayed evacuation to definitive care.Methods Twenty-eight pigs (47±6kg) were assigned to: (1) control, no procedure (n=7); (2) HS=hemorrhagic shock (n=13); and (3) RIPC+HS=remote ischemic preconditioning followed by hemorrhage (n=8). The animals were observed for 7 hours after bleeding without fluid replacement. Results Survival rate between animals that underwent RIPC before bleeding and those bled without prior RIPC were similar (HS, 6 of 13[46%]-vs-RIPC+HS, 4 of 8[50%], p=0.86 by Chi-square). Animals with prior RIPC had faster recovery of mean arterial pressure and developed higher heart rates without complications. Those with RIPC had less decrease in pH and bicarbonate, and the increase in lactate began later. Global oxygen delivery was higher, and tissue oxygen extraction ratio lower, in animals bled after RIPC. Conclusions These improvements after RIPC in hemodynamic and metabolic status provide essential substrates for improved cellular response after hemorrhage and reduction of the likelihood of potentially catastrophic consequences of the accompanying ischemia.
- Published
- 2021
46. Challenges in the homecoming of released prisoners of war: Israeli defense force preparations—A case study of freed prisoners of war from the Yom Kippur War and Second Lebanon War
- Author
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Ofir Levi, Eyal Fruchter, and Yitshak Kreiss
- Subjects
Political science ,Public Health, Environmental and Occupational Health ,Emergency Medicine ,Homecoming ,Ancient history ,General Nursing ,Prisoners of war - Published
- 2018
47. Real World Performance of SARS-CoV-2 Antigen Rapid Diagnostic Tests in Various Clinical Settings
- Author
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Michael J. Mina, Sharon Amit, Carmit Rubin, Gili Regev-Yochay, Bian Nadaf, Bella Mechnik, Or Kriger, Elad Biber, Sabrina Hason, Sharon Beni, and Yitshak Kreiss
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Diagnostic test ,Clinical settings ,Disease ,Asymptomatic ,Antigen ,Internal medicine ,medicine ,medicine.symptom ,Stage (cooking) ,business - Abstract
BackgroundSeveral uses of Antigen rapid diagnostic tests (Ag-RDT) have been suggested. Analytical studies reported high specificity yet with lower sensitivity for detecting SARS-CoV-2 compared to qRT-PCR. Here, we present the use of these tests as a decision support tool in several settings.MethodsSamples were collected for both Ag-RDT and qRT-PCR in three different clinical settings; 1. Symptomatic patients presenting at the Emergency Departments 2. Asymptomatic patients screened upon hospitalization and 3. Health-care workers (HCW) following SARS-CoV-2 exposure. Positive percent agreement (PPA), negative percent agreement (NPA), positive predictive value (PPV) and negative predictive value (NPV) were calculated. To estimate the association between Ct value, Ag-RDT and the number of days since SARS-CoV-2 exposure or symptomatic COVID-19, a mixed model was applied.ResultsA total of 5172 samples were obtained from 4595 individuals, with Ag-RDT and qRT-PCR results. Of these, 485 samples were positive by qRT-PCR. The PPA of Ag-RDT was greater for lower Ct values, reaching 93% in cases where Ct value was lower than 25 and 85% where Ct value was lower than 30. PPA was similar between symptomatic and asymptomatic individuals. The NPV and PPV were 96.8% and 99.1%, respectively. We observed a significant correlation between Ct value and time from infection onset (pConclusionsAg-RDT can be used as a decision support tool in various clinical settings and play a major role in early detection of SARS-CoV-2 infected individuals, highly specific and with high sensitivity to the infectious stage of disease, whether symptomatic or asymptomatic.
- Published
- 2021
48. Decreased Infectivity Following BNT162b2 Vaccination
- Author
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Yaniv Lustig, Marc Lipsitch, Yitshak Kreiss, Arnona Ziv, Amit Huppert, Gimpelevich I, Ram Doolman, Gili Regev-Yochay, Moriah Bergwerk, Eyal Leshem, Sharon Amit, Cindy Cohen, Carmit Rubin, Ilia Novikov, Galia Rahav, Rebecca Kahn, and Arnon Afek
- Subjects
Infectivity ,medicine.medical_specialty ,business.industry ,Rate ratio ,Asymptomatic ,Herd immunity ,Vaccination ,Antigen ,Relative risk ,Internal medicine ,Cohort ,Medicine ,medicine.symptom ,business - Abstract
Background: BNT162b2 was shown to be 92% effective in preventing COVID-19. Prioritizing vaccine rollout, and achievement of herd immunity depend on SARS-CoV-2 transmission reduction. The vaccine’s effect on infectivity is thus a critical priority. Methods: In a cohort of all 9650 HCW of a large single tertiary medical center, we calculated the prevalence of positive SAR-CoV-2 qRT-PCR cases with an asymptomatic presentation, tested following known or presumed exposure and the infectious subset (N-gene-Ct-value
- Published
- 2021
49. BNT162b2 Vaccine-Induced Immune Responses and Dynamics Vary Among Age Groups, Sex and Co-Morbidities: A Longitudinal Prospective Cohort Study
- Author
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Carmit Rubin, Victoria Indenbaum, Einav Sapir, Laurence S. Freedman, Amit Huppert, Ronen Fluss, Liraz Olmer, Yaniv Lustig, Ella Mendelson, Ram Doolman, Yitshak Kreiss, Gili Regev-Yochay, Carmit Cohen, Sharon Amit, Arnona Ziv, and Michal Mandelboim
- Subjects
biology ,business.industry ,medicine.medical_treatment ,Immunosuppression ,Neutralization ,Vaccination ,Titer ,Immune system ,Immunology ,biology.protein ,medicine ,Antibody ,Prospective cohort study ,Neutralizing antibody ,business - Abstract
Background: Concurrent to BNT162b2 vaccine rollout in Israel, we performed a longitudinal prospective cohort study to assess the early antibody response and antibody kinetics after each vaccine dose among health care workers (HCW) of different ages, gender and co-morbidities. Methods: Overall 2,607 vaccinated HCW were followed for five weeks after vaccination and Immunoglobulin (Ig)M, IgA, IgG and neutralizing antibodies were measured by Beckman-coulter SARS-CoV-2 RBD IgG, ELISA-RBD and pseudo-virus neutralization assays. Scatter plot and correlation analyses, logistic and linear regression analyses and linear mixed models were used to investigate the longitudinal antibody response. Findings: The first vaccine dose elicited low IgG and neutralizing antibody response in the majority of HCW which were rapidly induced 10 and 32 folds, respectively following the second vaccine dose. High (r=0.92) correlation was detected between IgG and neutralizing titers. First dose induced IgG response was significantly lower in older (>65, Ratio of means=0.25 95%CI 0.19-0.31) and immunosuppressed (0.21 95%CI 0.14-0.31) individuals. Yet, this was partially abrogated following the second dose. Overall, lower antibody levels were consistently associated with males (0.84 95%CI 0.80-0.89), older age (>65, 0.64 95%CI 0.58-0.71), immunosuppression (0.44 95%CI 0.33-0.58), and other specific comorbidities (diabetes (0.88 95%CI 0.79-0.98), hypertension (0.90 95%CI 0.82-0.98), heart disease (0.86 95%CI 0.75-0.99) and autoimmune diseases (0.82 95%CI 0.73-0.92). Interpretation: BNT162b2 vaccine induces a strong and rapid antibody response. The significant correlation between IgG antibodies and neutralization titers, suggest that IgG antibodies may serve as a correlate of neutralization. The second vaccine dose is significantly more important for older and immunosuppressed individuals. Antibody responses were reduced in vulnerable populations and therefore they may be more prone to breakthrough infections. Declaration of interests: None to declare. Ethics statement: The protocol and informed consent were approved by the Institutional review 125 board of the Sheba Medical Center. Written informed consent was obtained from all 126 participants. Funding: MOH and Sheba medical Center, Israel
- Published
- 2021
50. COVID-19 vaccine efficacy data: solid enough to delay second dose? – Authors' reply
- Author
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Gili Regev-Yochay, Sharon Amit, Arnon Afek, Eyal Leshem, and Yitshak Kreiss
- Subjects
Vaccines ,2019-20 coronavirus outbreak ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Diagnostic Tests, Routine ,SARS-CoV-2 ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,MEDLINE ,COVID-19 ,Diagnostic test ,General Medicine ,Vaccine efficacy ,Virology ,Correspondence ,Humans ,Medicine ,business ,BNT162 Vaccine - Published
- 2021
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