13 results on '"Shirley Collie"'
Search Results
2. Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study)
- Author
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Glenda Gray, Nigel Garrett, Ameena Goga, Amber Khan, Ishen Seocharan, Ian Sanne, Jonny Peter, Shirley Collie, Nonhlanhla Yende-Zuma, Barry Frank Jacobson, Elise Schapkaitz, Azwi Takalani, Jessica Opie, Tarylee Reddy, Michelle Robinson, Simbarashe Takuva, Pradeep Rowji, and Vernon Johan Louw
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Medicine - Abstract
Objective To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.Design Open label, single arm, phase 3B study.Setting Sisonke study, South Africa, 17 February to 15 June 2021.Participants The Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine.Main outcome measures Observed rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from the Clinical Practice Research Datalink GOLD database (database of longitudinal routinely collected electronic health records from UK primary care practices using Vision general practice patient management software).Results Most of the study participants were women (74.9%) and median age was 42 years (interquartile range 33-51). Twenty nine (30.6 per 100 000 person years, 95% confidence interval 20.5 to 44.0) vascular thrombotic events occurred at a median of 14 days (7-29) after vaccination. Of these 29 participants, 93.1% were women, median age 46 (37-55) years, and 51.7% had comorbidities. The observed to expected ratios for cerebral venous sinus thrombosis with thrombocytopenia and pulmonary embolism with thrombocytopenia were 10.6 (95% confidence interval 0.3 to 58.8) and 1.2 (0.1 to 6.5), respectively. Because of the small number of adverse events and wide confidence intervals, no conclusions were drawn between these estimates and the expected incidence rates in the population.Conclusions Vaccine induced immune thrombocytopenia and thrombosis after one dose of the Ad26.COV2.S vaccine was found in only a few patients in this South African population of healthcare workers. These findings are reassuring if considered in terms of the beneficial effects of vaccination against covid-19 disease. These data support the continued use of this vaccine, but surveillance is recommended to identify other incidences of venous and arterial thromboembolism and to improve confidence in the data estimates.Trial registration ClinicalTrials.gov NCT04838795.
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- 2023
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3. Assessing COVID-19 vaccine effectiveness against Omicron subvariants: Report from a meeting of the World Health Organization
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Daniel R. Feikin, Melissa M. Higdon, Nick Andrews, Shirley Collie, Maria Deloria Knoll, Jeffrey C. Kwong, Ruth Link-Gelles, Tamara Pilishvili, and Minal K. Patel
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Infectious Diseases ,General Veterinary ,General Immunology and Microbiology ,Public Health, Environmental and Occupational Health ,Molecular Medicine - Published
- 2023
4. Setting up data science research in Africa and engagement of stakeholders
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Alash’ le Abimiku, Adetifa Ifedayo, Gambo Aliyu, Waasila Jassat, Shirley Collie, Patrick Dakum, Vivek Naranbhai, Chenfeng Xiong, Manhattan Charurat, Jibreel Jumare, and Fati Murtala-Ibrahim
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General Earth and Planetary Sciences ,General Agricultural and Biological Sciences ,General Biochemistry, Genetics and Molecular Biology - Published
- 2023
5. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study
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Linda-Gail Bekker, Nigel Garrett, Ameena Goga, Lara Fairall, Tarylee Reddy, Nonhlanhla Yende-Zuma, Reshma Kassanjee, Shirley Collie, Ian Sanne, Andrew Boulle, Ishen Seocharan, Imke Engelbrecht, Mary-Ann Davies, Jared Champion, Tommy Chen, Sarah Bennett, Selaelo Mametja, Mabatlo Semenya, Harry Moultrie, Tulio de Oliveira, Richard John Lessells, Cheryl Cohen, Waasila Jassat, Michelle Groome, Anne Von Gottberg, Engelbert Le Roux, Kentse Khuto, Dan Barouch, Hassan Mahomed, Milani Wolmarans, Petro Rousseau, Debbie Bradshaw, Michelle Mulder, Jessica Opie, Vernon Louw, Barry Jacobson, Pradeep Rowji, Jonny G Peter, Azwi Takalani, Jackline Odhiambo, Fatima Mayat, Simbarashe Takuva, Lawrence Corey, Glenda E Gray, William Brumskine, Nivashnee Naicker, Disebo Makhaza, Vimla Naicker, Logashvari Naidoo, Elizabeth Spooner, Elane van Nieuwenhuizen, Kathryn Mngadi, Maphoshane Nchabeleng, James Craig Innes, Katherine Gill, Friedrich Georg Petrick, Shaun Barnabas, Sharlaa Badal-Faesen, Sheetal Kassim, Scott Hayden Mahoney, Erica Lazarus, Anusha Nana, Rebone Molobane Maboa, Philip Kotze, Johan Lombaard, Daniel Rudolf Malan, Sheena Kotze, Phuthi Mohlala, Amy Ward, Graeme Meintjes, Dorothea Urbach, Faeezah Patel, Andreas Diacon, Khatija Ahmed, Coert Grobbelaar, Pamela Mda, Thozama Dubula, Angelique Luabeya, Musawenkosi Bhekithemba Mamba, Lesley Burgess, and Rodney Dawson
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Adult ,Male ,South Africa ,Vaccines ,Ad26COVS1 ,Adolescent ,SARS-CoV-2 ,COVID-19 ,Humans ,Female ,HIV Infections ,General Medicine ,Aged - Abstract
We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (JohnsonJohnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic.In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 10Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74·9%) were female and 119 701 (25·1%) were male, with a median age of 42·0 years (33·0-51·0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83% (95% CI 75-89) to prevent COVID-19-related deaths, 75% (69-82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67% (62-71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62% [95% CI 42-76] and during delta wave was 67% [62-71], and vaccine effectiveness against COVID-19-related death during beta wave was 86% [57-100] and during delta wave was 82% [74-89]).The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally.National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The MichaelSusan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the BillMelinda Gates Foundation.
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- 2022
6. Effectiveness of Ad26.COV2.S and BNT162b2 Vaccines against Omicron Variant in South Africa
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Glenda Gray, Shirley Collie, Ameena Goga, Nigel Garrett, Jared Champion, Ishen Seocharan, Lesley Bamford, Harry Moultrie, and Linda-Gail Bekker
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South Africa ,Vaccines ,Ad26COVS1 ,SARS-CoV-2 ,COVID-19 ,Humans ,Vaccine Efficacy ,General Medicine ,BNT162 Vaccine - Published
- 2022
7. Association between regular physical activity and the protective effect of vaccination against SARS-CoV-2 in a South African case-control study
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Shirley Collie, Robin Terence Saggers, Rossella Bandini, Lizelle Steenkamp, Jared Champion, Glenda Gray, Linda-Gail Bekker, Ameena Goga, Nigel Garrett, and Jon Patricios
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Physical Therapy, Sports Therapy and Rehabilitation ,Orthopedics and Sports Medicine ,General Medicine - Abstract
BackgroundBoth vaccination and physical activity have been shown to independently decrease the likelihood of severe COVID-19 infection.ObjectiveTo assess the association between regular physical activity and vaccination against COVID-19 among healthcare workers.MethodsA test negative case–control study design was used to estimate the risk of having an associated COVID-19-related hospital admission, among individuals who were unvaccinated compared with those who were fully vaccinated with Ad26.COV2.S (>28 days after a single dose). 196 444 participant tests were stratified into three measured physical activity subgroups with low, moderate and high activity, to test the hypothesis that physical activity is an effect modifier on the relationship between vaccination and hospitalisation.ResultsVaccine effectiveness against a COVID-19-related admission among vaccinated individuals within the low activity group was 60.0% (95% CI 39.0 to 73.8), 72.1% (95% CI 55.2 to 82.6) for the moderate activity group, and 85.8% (95% CI 74.1 to 92.2) for the high activity group. Compared with individuals with low activity levels, vaccinated individuals with moderate and high activity levels had a 1.4 (95% CI 1.36 to 1.51) and 2.8 (95% CI 2.35 to 3.35) times lower risk of COVID-19 admission, respectively (p value ConclusionsRegular physical activity was associated with improved vaccine effectiveness against COVID-19 hospitalisation, with higher levels of physical activity associated with greater vaccine effectiveness. Physical activity enhances vaccine effectiveness against severe COVID-19 outcomes and should be encouraged by greater public health messaging.
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- 2022
8. Effectiveness and Durability of the BNT162b2 Vaccine against Omicron Sublineages in South Africa
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Shirley Collie, Jiren Nayager, Lesley Bamford, Linda-Gail Bekker, Matt Zylstra, and Glenda Gray
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South Africa ,SARS-CoV-2 ,Vaccination ,COVID-19 ,Humans ,Vaccine Efficacy ,General Medicine ,BNT162 Vaccine - Published
- 2022
9. Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study)
- Author
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Barry Frank Jacobson, Elise Schapkaitz, Azwi Takalani, Pradeep Frank Rowji, Vernon Louw, Jessica Opie, Linda Gail Bekker, Nigel Garrett, Ameena Goga, Tarylee Reddy, Nonhlanhla Yende Zuma, Ian Sanne, Ishen Seocharan, Jonny Peter, Michelle Robinson, Shirley Collie, Amber Khan, Simbarashe Takuva, and Glenda Gray
- Abstract
ObjectiveTo assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.DesignOpen label, single arm, phase 3B study.SettingSisonke study, South Africa, 17 February to 15 June 2021.ParticipantsThe Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine.Main outcome measuresObserved rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from the Clinical Practice Research Datalink GOLD database (database of longitudinal routinely collected electronic health records from UK primary care practices using Vision general practice patient management software).ResultsMost of the study participants were women (74.9%) and median age was 42 years (interquartile range 33-51). Twenty nine (30.6 per 100 000 person years, 95% confidence interval 20.5 to 44.0) vascular thrombotic events occurred at a median of 14 days (7-29) after vaccination. Of these 29 participants, 93.1% were women, median age 46 (37-55) years, and 51.7% had comorbidities. The observed to expected ratios for cerebral venous sinus thrombosis with thrombocytopenia and pulmonary embolism with thrombocytopenia were 10.6 (95% confidence interval 0.3 to 58.8) and 1.2 (0.1 to 6.5), respectively. Because of the small number of adverse events and wide confidence intervals, no conclusions were drawn between these estimates and the expected incidence rates in the population.ConclusionsVaccine induced immune thrombocytopenia and thrombosis after one dose of the Ad26.COV2.S vaccine was found in only a few patients in this South African population of healthcare workers. These findings are reassuring if considered in terms of the beneficial effects of vaccination against covid-19 disease. These data support the continued use of this vaccine, but surveillance is recommended to identify other incidences of venous and arterial thromboembolism and to improve confidence in the data estimates.Trial registrationClinicalTrials.govNCT04838795.
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- 2023
10. Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa
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Shirley Collie, Jared Champion, Harry Moultrie, Linda-Gail Bekker, and Glenda Gray
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South Africa ,Logistic Models ,SARS-CoV-2 ,Correspondence ,Humans ,Vaccine Efficacy ,General Medicine ,BNT162 Vaccine - Published
- 2021
11. Vaccine effectiveness against hospital admission in South African health care workers who received a homologous booster of Ad26.COV2 during an Omicron COVID19 wave: Preliminary Results of the Sisonke 2 Study
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Glenda E Gray, Shirley Collie, Nigel Garrett, Ameena Goga, Jared Champion, Matthew Zylstra, Tarylee Reddy, Nonhlanhla Yende, Ishen Seocharan, Azwi Takalani, Ian Sanne, Fatima Mayat, Jacky Odhiambo, Lesley Bamford, Harry Moultrie, Lara Fairall, and Linda-Gail Bekker
- Abstract
Following the results of the ENSEMBLE 2 study, which demonstrated improved vaccine efficacy of a two-dose regimen of Ad26.COV.2 vaccine given 2 months apart, we expanded the Sisonke study which had provided single dose Ad26.COV.2 vaccine to almost 500 000 health care workers (HCW) in South Africa to include a booster dose of the Ad26.COV.2. Sisonke 2 enrolled 227 310 HCW from the 8 November to the 17 December 2021. Enrolment commenced before the onset of the Omicron driven fourth wave in South Africa affording us an opportunity to evaluate early VE in preventing hospital admissions of a homologous boost of the Ad26.COV.2 vaccine given 6-9 months after the initial vaccination in HCW.We estimated vaccine effectiveness (VE) of the Ad26.COV2.S vaccine booster in 69 092 HCW as compared to unvaccinated individuals enrolled in the same managed care organization using a test negative design. We compared VE against COVID19 admission for omicron during the period 15 November to 20 December 2021. After adjusting for confounders, we observed that VE for hospitalisation increased over time since booster dose, from 63% (95%CI 31-81%); to 84% (95% CI 67-92%) and then 85% (95% CI: 54-95%), 0-13 days, 14-27 days, and 1-2 months post-boost.We provide the first evidence of the effectiveness of a homologous Ad26.COV.2 vaccine boost given 6-9 months after the initial single vaccination series during a period of omicron variant circulation. This data is important given the increased reliance on the Ad26.COV.2 vaccine in Africa.
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- 2021
12. Effectiveness of the Ad26.Cov2.S Vaccine in Health Care Workers in South Africa
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Linda-Gail Bekker, Nigel Garrett, Ameena Goga, Lara Fairall, Tarylee Reddy, Nonhlanhla Yende-Zuma, Reshma Kassanje, Shirley Collie, Ian Sanne, Andrew Boulle, Ishen Seocharan, Imke Engelbrecht, Mary-Ann Davies, Jared Champion, Tommy Chen, Sarah Bennett, Selaelo Mametja, Mabatlo Semenya, Harry Moultrie, Tulio de Oliveira, Richard Lessells, Cheryl Cohen, Waasila Jassat, Michelle Groome, Ann Von Gottberg, Engelbert Le Roux, Kentse Khuto, Dan H. Barouch, Mahomed Hassan, Milani Wolmarans, Petro Rousseau, Debbie Bradshaw, Michelle Mulder, Opie Jessica, Vernon Louw, Barry Jacobson, Pradeep Rowji, Jonny Peter, Azwi Takalani, Jackline Odhiambo, Fatima Mayat, Simbarashe Takuva, Lawrence Corey, and Glenda Gray
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History ,Polymers and Plastics ,Business and International Management ,Industrial and Manufacturing Engineering - Published
- 2021
13. The impact of routine pulse oximetry use on outcomes in COVID-19-infected patients at increased risk of severe disease: A retrospective cohort analysis
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Charles Feldman, Jared Champion, Guy A. Richards, Shirley Collie, Tommy Chen, Michael F. Cohen, and Noluthando Nematswerani
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Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Severity of Illness Index ,law.invention ,Cohort Studies ,South Africa ,law ,Statistical significance ,Internal medicine ,Humans ,Medicine ,Oximetry ,education ,Retrospective Studies ,Mechanical ventilation ,education.field_of_study ,Respiratory distress ,medicine.diagnostic_test ,business.industry ,Mortality rate ,Hazard ratio ,COVID-19 ,Retrospective cohort study ,General Medicine ,Middle Aged ,medicine.disease ,Respiration, Artificial ,Intensive care unit ,Comorbidity ,Hospitalization ,Intensive Care Units ,Pulse oximetry ,C-Reactive Protein ,Oxygen Saturation ,Emergency medicine ,Female ,business - Abstract
Background: A phenomenon of silent hypoxaemia has been described in patients with COVID-19 pneumonia, which is characterised by low oxygen saturation levels of < 90% in patients who appear clinically well and do not show signs of significant respiratory distress. We assessed the impact on clinical outcomes for high-risk COVID-19 patients using a pulse oximeter to monitor oxygen saturation levels in a home setting. Methods: We performed a retrospective cohort analysis using data from a large South African insurance administrator. Patients were categorised as high risk, based on age or if they had specific underlying clinical conditions, or if they were classified as high risk from predictive models based on medical scheme administrative claims data. The impact of pulse oximetry home monitoring on COVID-19 clinical outcomes were investigated by use of Cox proportional hazard models. Findings: Between 2 March 2020 and 31 October 2020, of 38 645 patients analysed, 8 113 were in the intervention group. The 60-day mortality rate for the evaluated high-risk population was 1·35%. After adjusting for the age and co-morbidity differences, the intervention group was found to have an adjusted hazard ratio (HR) of 0·52 (p
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- 2021
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