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1. Influenza vaccination stimulates maturation of the human T follicular helper cell response

Author

Schattgen, Stefan A., Turner, Jackson S., Ghonim, Mohamed A., Crawford, Jeremy Chase, Schmitz, Aaron J., Kim, Hyunjin, Zhou, Julian Q., Awad, Walid, Mettelman, Robert C., Kim, Wooseob, McIntire, Katherine M., Haile, Alem, Klebert, Michael K., Suessen, Teresa, Middleton, William D., Teefey, Sharlene A., Presti, Rachel M., Ellebedy, Ali H., and Thomas, Paul G.

Published
2024
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2. CD4+ T cells exhibit distinct transcriptional phenotypes in the lymph nodes and blood following mRNA vaccination in humans

Author

Borcherding, Nicholas, Kim, Wooseob, Quinn, Michael, Han, Fangjie, Zhou, Julian Q., Sturtz, Alexandria J., Schmitz, Aaron J., Lei, Tingting, Schattgen, Stefan A., Klebert, Michael K., Suessen, Teresa, Middleton, William D., Goss, Charles W., Liu, Chang, Crawford, Jeremy Chase, Thomas, Paul G., Teefey, Sharlene A., Presti, Rachel M., O’Halloran, Jane A., Turner, Jackson S., Ellebedy, Ali H., and Mudd, Philip A.

Published
2024
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3. A simple point-of-care assay accurately detects anti-spike antibodies after SARS-CoV-2 vaccination

Author

Greene, Sarah E, Huang, Yuefang, Kim, Wooseob, Liebeskind, Mariel J, Chandrasekaran, Vinay, Liu, Zhuoming, Deepak, Parakkal, Paley, Michael A, Lew, Daphne, Yang, Monica, Matloubian, Mehrdad, Gensler, Lianne S, Nakamura, Mary C, O'Hallaran, Jane A, Presti, Rachel M, Whelan, Sean PJ, Buchser, William J, Kim, Alfred HJ, and Weil, Gary J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Vaccine Related, Emerging Infectious Diseases, Biodefense, Biotechnology, Infectious Diseases, Clinical Research, Immunization, Prevention, Infection, Good Health and Well Being, SARS-COV-2, Antibody test, Vaccination, Immunocompromise
Abstract

ObjectiveLateral flow assays (LFA) are sensitive for detecting antibodies to SARS-CoV-2 proteins within weeks after infection. This study tested samples from immunocompetent adults, and those receiving treatments for chronic inflammatory diseases (CID), before and after mRNA SARS-CoV-2 vaccination.MethodsWe compared results obtained with the COVIBLOCK Covid-19 LFA to those obtained by anti-spike (S) ELISA.ResultsThe LFA detected anti-S antibodies in 29 of 29 (100%) of the immunocompetent and 110 of 126 (87.3%) of the CID participants after vaccination. Semiquantitative LFA scores were statistically significantly lower in samples from immunosuppressed participants, and were significantly correlated with anti-S antibody levels measured by ELISA.ConclusionsThis simple LFA test is a practical alternative to laboratory-based assays for detecting anti-S antibodies after infection or vaccination. This type of test may be most useful for testing people in outpatient or resource-limited settings.

Published
2023

4. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C. S., Kamidani, Satoshi, Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David C., Makowski, Mat, Smith, Derek J., Nayak, Seema U., Roberts, Paul C., and Beigel, John H.

Published
2023
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5. Effect of Immunosuppression on the Immunogenicity of mRNA Vaccines to SARS-CoV-2

Author

Deepak, Parakkal, Kim, Wooseob, Paley, Michael A, Yang, Monica, Carvidi, Alexander B, Demissie, Emanuel G, El-Qunni, Alia A, Haile, Alem, Huang, Katherine, Kinnett, Baylee, Liebeskind, Mariel J, Liu, Zhuoming, McMorrow, Lily E, Paez, Diana, Pawar, Niti, Perantie, Dana C, Schriefer, Rebecca E, Sides, Shannon E, Thapa, Mahima, Gergely, Maté, Abushamma, Suha, Akuse, Sewuese, Klebert, Michael, Mitchell, Lynne, Nix, Darren, Graf, Jonathan, Taylor, Kimberly E, Chahin, Salim, Ciorba, Matthew A, Katz, Patricia, Matloubian, Mehrdad, O'Halloran, Jane A, Presti, Rachel M, Wu, Gregory F, Whelan, Sean PJ, Buchser, William J, Gensler, Lianne S, Nakamura, Mary C, Ellebedy, Ali H, and Kim, Alfred HJ

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Prevention, Rare Diseases, Emerging Infectious Diseases, Immunization, Vaccine Related, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Good Health and Well Being, Public Health and Health Services
Abstract

BackgroundPatients with chronic inflammatory disease (CID) treated with immunosuppressive medications have increased risk for severe COVID-19. Although mRNA-based SARS-CoV-2 vaccination provides protection in immunocompetent persons, immunogenicity in immunosuppressed patients with CID is unclear.ObjectiveTo determine the immunogenicity of mRNA-based SARS-CoV-2 vaccines in patients with CID.DesignProspective observational cohort study.SettingTwo U.S. CID referral centers.ParticipantsVolunteer sample of adults with confirmed CID eligible for early COVID-19 vaccination, including hospital employees of any age and patients older than 65 years. Immunocompetent participants were recruited separately from hospital employees. All participants received 2 doses of mRNA vaccine against SARS-CoV-2 between 10 December 2020 and 20 March 2021. Participants were assessed within 2 weeks before vaccination and 20 days after final vaccination.MeasurementsAnti-SARS-CoV-2 spike (S) IgG+ binding in all participants, and neutralizing antibody titers and circulating S-specific plasmablasts in a subset to assess humoral response after vaccination.ResultsMost of the 133 participants with CID (88.7%) and all 53 immunocompetent participants developed antibodies in response to mRNA-based SARS-CoV-2 vaccination, although some with CID developed numerically lower titers of anti-S IgG. Anti-S IgG antibody titers after vaccination were lower in participants with CID receiving glucocorticoids (n = 17) than in those not receiving them; the geometric mean of anti-S IgG antibodies was 357 (95% CI, 96 to 1324) for participants receiving prednisone versus 2190 (CI, 1598 to 3002) for those not receiving it. Anti-S IgG antibody titers were also lower in those receiving B-cell depletion therapy (BCDT) (n = 10). Measures of immunogenicity differed numerically between those who were and those who were not receiving antimetabolites (n = 48), tumor necrosis factor inhibitors (n = 39), and Janus kinase inhibitors (n = 11); however, 95% CIs were wide and overlapped. Neutralization titers seemed generally consistent with anti-S IgG results. Results were not adjusted for differences in baseline clinical factors, including other immunosuppressant therapies.LimitationsSmall sample that lacked demographic diversity, and residual confounding.ConclusionCompared with nonusers, patients with CID treated with glucocorticoids and BCDT seem to have lower SARS-CoV-2 vaccine-induced antibody responses. These preliminary findings require confirmation in a larger study.Primary funding sourceThe Leona M. and Harry B. Helmsley Charitable Trust, Marcus Program in Precision Medicine Innovation, National Center for Advancing Translational Sciences, and National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Published
2021

6. SARS-CoV-2 Omicron boosting induces de novo B cell response in humans

Author

Alsoussi, Wafaa B., Malladi, Sameer Kumar, Zhou, Julian Q., Liu, Zhuoming, Ying, Baoling, Kim, Wooseob, Schmitz, Aaron J., Lei, Tingting, Horvath, Stephen C., Sturtz, Alexandria J., McIntire, Katherine M., Evavold, Birk, Han, Fangjie, Scheaffer, Suzanne M., Fox, Isabella F., Mirza, Senaa F., Parra-Rodriguez, Luis, Nachbagauer, Raffael, Nestorova, Biliana, Chalkias, Spyros, Farnsworth, Christopher W., Klebert, Michael K., Pusic, Iskra, Strnad, Benjamin S., Middleton, William D., Teefey, Sharlene A., Whelan, Sean P. J., Diamond, Michael S., Paris, Robert, O’Halloran, Jane A., Presti, Rachel M., Turner, Jackson S., and Ellebedy, Ali H.

Published
2023
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8. Distinct Inflammatory Profiles Distinguish COVID-19 from Influenza with Limited Contributions from Cytokine Storm

Author

Mudd, Philip A., primary, Crawford, Jeremy Chase, additional, Turner, Jackson S., additional, Souquette, Aisha, additional, Reynolds, Daniel, additional, Bender, Diane, additional, Bosanquet, James P., additional, Anand, Nitin J., additional, Striker, David A., additional, Martin, R. Scott, additional, Boon, Adrianus C. M., additional, House, Stacey L., additional, Remy, Kenneth E., additional, Hotchkiss, Richard S., additional, Presti, Rachel M., additional, O’Halloran, Jane A., additional, Powderly, William G., additional, Thomas, Paul G., additional, and Ellebedy, Ali H., additional

Published
2023
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10. mRNA vaccine boosting enhances antibody responses against SARS-CoV-2 Omicron variant in individuals with antibody deficiency syndromes

Author

Zimmerman, Ofer, Altman Doss, Alexa Michelle, Kaplonek, Paulina, Liang, Chieh-Yu, VanBlargan, Laura A., Chen, Rita E., Monroy, Jennifer Marie, Wedner, H. James, Kulczycki, Anthony, Jr., Mantia, Tarisa L., O’Shaughnessy, Caitlin C., Davis-Adams, Hannah G., Bertera, Harry L., Adams, Lucas J., Raju, Saravanan, Zhao, Fang R., Rigell, Christopher J., Dy, Tiffany Biason, Kau, Andrew L., Ren, Zhen, Turner, Jackson S., O’Halloran, Jane A., Presti, Rachel M., Fremont, Daved H., Kendall, Peggy L., Ellebedy, Ali H., Alter, Galit, and Diamond, Michael S.

Published
2022
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11. Germinal centre-driven maturation of B cell response to mRNA vaccination

Author

Kim, Wooseob, Zhou, Julian Q., Horvath, Stephen C., Schmitz, Aaron J., Sturtz, Alexandria J., Lei, Tingting, Liu, Zhuoming, Kalaidina, Elizaveta, Thapa, Mahima, Alsoussi, Wafaa B., Haile, Alem, Klebert, Michael K., Suessen, Teresa, Parra-Rodriguez, Luis, Mudd, Philip A., Whelan, Sean P. J., Middleton, William D., Teefey, Sharlene A., Pusic, Iskra, O’Halloran, Jane A., Presti, Rachel M., Turner, Jackson S., and Ellebedy, Ali H.

Published
2022
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12. Alterations in the oral microbiome in HIV-infected participants after antiretroviral therapy administration are influenced by immune status

Author

Presti, Rachel M, Handley, Scott A, Droit, Lindsay, Ghannoum, Mahmoud, Jacobson, Mark, Shiboski, Caroline H, Webster-Cyriaque, Jennifer, Brown, Todd, Yin, Michael T, and Overton, Edgar T

Subjects
Biomedical and Clinical Sciences, Dentistry, HIV/AIDS, Infectious Diseases, Dental/Oral and Craniofacial Disease, 2.1 Biological and endogenous factors, Aetiology, Infection, Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Cluster Analysis, Cohort Studies, DNA, Bacterial, DNA, Ribosomal, Female, Follow-Up Studies, HIV Infections, Humans, Male, Microbiota, Middle Aged, Phylogeny, RNA, Ribosomal, 16S, Saliva, Sequence Analysis, DNA, Young Adult, anti-HIV agents, HIV, human microbiome, saliva, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveTo characterize the oral bacterial microbiome in HIV-infected participants at baseline and after 24 weeks of EFV/FTC/TDF.DesignThirty-five participants co-enrolled in two AIDS Clinical Trials Group (ACTG) studies, A5272 and A5280, with paired saliva samples and complete data sets were assessed.MethodsPaired saliva samples were evaluated for bacterial microbiome using 16S rDNA PCR followed by Illumina sequencing. Diversity and differential abundance was compared between groups. A random forest classification scheme was used to determine the contribution of parameters in classifying participants' CD4+ T-cell count.ResultsBacterial communities demonstrated considerable variability both within participants and between timepoints, although they became more similar after 24 weeks of ART. At baseline, both the number of taxa detected and the average alpha diversity were variable between participants, but did not differ significantly based on CD4+ cell count, viral load or other factors. After 24 weeks of ART samples obtained from participants with persistently low CD4+ T-cell counts had significantly higher bacterial richness and diversity. Several differentially abundant taxa, including Porphyromonas species associated with periodontal disease, were identified, which discriminated between baseline and posttreatment samples. Analysis demonstrated that although inflammatory markers are important in untreated disease, the salivary microbiome may play an important role in CD4+ T-cell count recovery after ART.ConclusionShifts in the oral microbiome after ART initiation are complex, and may play an important role in immune function and inflammatory disease.

Published
2018

13. Reduced antibody activity against SARS-CoV-2 B.1.617.2 delta virus in serum of mRNA-vaccinated individuals receiving tumor necrosis factor-α inhibitors

Author

Chen, Rita E., Gorman, Matthew J., Zhu, Daniel Y., Carreño, Juan Manuel, Yuan, Dansu, VanBlargan, Laura A., Burdess, Samantha, Lauffenburger, Douglas A., Kim, Wooseob, Turner, Jackson S., Droit, Lindsay, Handley, Scott A., Chahin, Salim, Deepak, Parakkal, O’Halloran, Jane A., Paley, Michael A., Presti, Rachel M., Wu, Gregory F., Krammer, Florian, Alter, Galit, Ellebedy, Ali H., Kim, Alfred H.J., and Diamond, Michael S.

Published
2021
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14. SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans

Author

Turner, Jackson S., Kim, Wooseob, Kalaidina, Elizaveta, Goss, Charles W., Rauseo, Adriana M., Schmitz, Aaron J., Hansen, Lena, Haile, Alem, Klebert, Michael K., Pusic, Iskra, O'Halloran, Jane A., and Presti, Rachel M.

Subjects
Bone marrow -- Health aspects, Plasma cells -- Health aspects, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Long-lived bone marrow plasma cells (BMPCs) are a persistent and essential source of protective antibodies.sup.1-7. Individuals who have recovered from COVID-19 have a substantially lower risk of reinfection with SARS-CoV-2.sup.8-10. Nonetheless, it has been reported that levels of anti-SARS-CoV-2 serum antibodies decrease rapidly in the first few months after infection, raising concerns that long-lived BMPCs may not be generated and humoral immunity against SARS-CoV-2 may be short-lived.sup.11-13. Here we show that in convalescent individuals who had experienced mild SARS-CoV-2 infections (n = 77), levels of serum anti-SARS-CoV-2 spike protein (S) antibodies declined rapidly in the first 4 months after infection and then more gradually over the following 7 months, remaining detectable at least 11 months after infection. Anti-S antibody titres correlated with the frequency of S-specific plasma cells in bone marrow aspirates from 18 individuals who had recovered from COVID-19 at 7 to 8 months after infection. S-specific BMPCs were not detected in aspirates from 11 healthy individuals with no history of SARS-CoV-2 infection. We show that S-binding BMPCs are quiescent, which suggests that they are part of a stable compartment. Consistently, circulating resting memory B cells directed against SARS-CoV-2 S were detected in the convalescent individuals. Overall, our results indicate that mild infection with SARS-CoV-2 induces robust antigen-specific, long-lived humoral immune memory in humans. SARS-CoV-2 infection induces long-lived bone marrow plasma cells that correlate with anti-SARS-CoV-2 spike protein antibody titres in individuals who have recovered from COVID-19., Author(s): Jackson S. Turner [sup.1] , Wooseob Kim [sup.1] , Elizaveta Kalaidina [sup.2] , Charles W. Goss [sup.3] , Adriana M. Rauseo [sup.4] , Aaron J. Schmitz [sup.1] , Lena [...]

Published
2021
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15. SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses

Author

Turner, Jackson S., O’Halloran, Jane A., Kalaidina, Elizaveta, Kim, Wooseob, Schmitz, Aaron J., Zhou, Julian Q., Lei, Tingting, Thapa, Mahima, Chen, Rita E., Case, James Brett, Amanat, Fatima, Rauseo, Adriana M., Haile, Alem, Xie, Xuping, Klebert, Michael K., Suessen, Teresa, Middleton, William D., Shi, Pei-Yong, Krammer, Florian, Teefey, Sharlene A., Diamond, Michael S., Presti, Rachel M., and Ellebedy, Ali H.

Published
2021
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16. Resistance of SARS-CoV-2 variants to neutralization by monoclonal and serum-derived polyclonal antibodies

Author

Chen, Rita E., Zhang, Xianwen, Case, James Brett, Winkler, Emma S., Liu, Yang, VanBlargan, Laura A., Liu, Jianying, Errico, John M., Xie, Xuping, Suryadevara, Naveenchandra, Gilchuk, Pavlo, Zost, Seth J., Tahan, Stephen, Droit, Lindsay, Turner, Jackson S., Kim, Wooseob, Schmitz, Aaron J., Thapa, Mahima, Wang, David, Boon, Adrianus C. M., Presti, Rachel M., O’Halloran, Jane A., Kim, Alfred H. J., Deepak, Parakkal, Pinto, Dora, Fremont, Daved H., Crowe, Jr, James E., Corti, Davide, Virgin, Herbert W., Ellebedy, Ali H., Shi, Pei-Yong, and Diamond, Michael S.

Published
2021
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17. Immunoglobulin replacement products confer in vivo protection against SARS-CoV-2 XBB.1.5 Omicron variant despite poor neutralizing activity

Author

Zimmerman, Ofer, primary, Altman Doss, Alexa Michelle, additional, Ying, Baoling, additional, Liang, Chieh-Yu, additional, Mackin, Samantha R., additional, Davis-Adams, Hannah G., additional, Adams, Lucas J., additional, VanBlargan, Laura A., additional, Chen, Rita E., additional, Scheaffer, Suzanne M., additional, Desai, Pritesh, additional, Raju, Saravanan, additional, Mantia, Tarisa L., additional, O'Shaughnessy, Caitlin C., additional, Monroy, Jennifer M., additional, Wedner, H. James, additional, Rigell, Christpher J., additional, Kau, Andrew L., additional, Dy, Tiffany B., additional, Ren, Zhen, additional, Turner, Jackson S., additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Kendall, Peggy L., additional, Fremont, Daved H., additional, Ellebedy, Ali H., additional, and Diamond, Michael S., additional

Published
2024
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18. Human germinal centres engage memory and naive B cells after influenza vaccination

Author

Turner, Jackson S., Zhou, Julian Q., Han, Julianna, Schmitz, Aaron J., Rizk, Amena A., Alsoussi, Wafaa B., Lei, Tingting, Amor, Mostafa, McIntire, Katherine M., Meade, Philip, Strohmeier, Shirin, Brent, Rafael I., Richey, Sara T., Haile, Alem, Yang, Yuhe R., Klebert, Michael K., Suessen, Teresa, Teefey, Sharlene, Presti, Rachel M., Krammer, Florian, Kleinstein, Steven H., Ward, Andrew B., and Ellebedy, Ali H.

Published
2020
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19. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial.

Author

Lennox, Jeffrey L, Landovitz, Raphael J, Ribaudo, Heather J, Ofotokun, Ighovwerha, Na, Lumine H, Godfrey, Catherine, Kuritzkes, Daniel R, Sagar, Manish, Brown, Todd T, Cohn, Susan E, McComsey, Grace A, Aweeka, Francesca, Fichtenbaum, Carl J, Presti, Rachel M, Koletar, Susan L, Haas, David W, Patterson, Kristine B, Benson, Constance A, Baugh, Bryan P, Leavitt, Randi Y, Rooney, James F, Seekins, Daniel, and Currier, Judith S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Sexually Transmitted Infections, Infectious Diseases, HIV/AIDS, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adenine, Adult, Atazanavir Sulfate, Darunavir, Deoxycytidine, Drug Combinations, Drug Therapy, Combination, Emtricitabine, Female, HIV Infections, HIV Protease Inhibitors, HIV-1, Humans, Male, Oligopeptides, Organophosphonates, Pyridines, RNA, Viral, Reverse Transcriptase Inhibitors, Sulfonamides, Tenofovir, Therapeutic Equivalency, Viral Load, ACTG A5257 Team, Public Health and Health Services
Abstract

BackgroundNonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy is not suitable for all treatment-naive HIV-infected persons.ObjectiveTo evaluate 3 nonnucleoside reverse transcriptase inhibitor-sparing initial antiretroviral regimens to show equivalence for virologic efficacy and tolerability.DesignA phase 3, open-label study randomized in a 1:1:1 ratio with follow-up for at least 96 weeks. (ClinicalTrials.gov: NCT00811954).Setting57 sites in the United States and Puerto Rico.PatientsTreatment-naive persons aged 18 years or older with HIV-1 RNA levels greater than 1000 copies/mL without resistance to nucleoside reverse transcriptase inhibitors or protease inhibitors.InterventionAtazanavir, 300 mg/d, with ritonavir, 100 mg/d; raltegravir, 400 mg twice daily; or darunavir, 800 mg/d, with ritonavir, 100 mg/d, plus combination emtricitabine, 200 mg/d, and tenofovir disoproxil fumarate, 300 mg/d.MeasurementsVirologic failure, defined as a confirmed HIV-1 RNA level greater than 1000 copies/mL at or after 16 weeks and before 24 weeks or greater than 200 copies/mL at or after 24 weeks, and tolerability failure, defined as discontinuation of atazanavir, raltegravir, or darunavir for toxicity. A secondary end point was a combination of virologic efficacy and tolerability.ResultsAmong 1809 participants, all pairwise comparisons of incidence of virologic failure over 96 weeks showed equivalence within a margin of equivalence defined as -10% to 10%. Raltegravir and ritonavir-boosted darunavir were equivalent for tolerability, whereas ritonavir-boosted atazanavir resulted in a 12.7% and 9.2% higher incidence of tolerability discontinuation than raltegravir and ritonavir-boosted darunavir, respectively, primarily because of hyperbilirubinemia. For combined virologic efficacy and tolerability, ritonavir-boosted darunavir was superior to ritonavir-boosted atazanavir, and raltegravir was superior to both protease inhibitors. Antiretroviral resistance at the time of virologic failure was rare but more frequent with raltegravir.LimitationThe trial was open-label, and ritonavir was not provided.ConclusionOver 2 years, all 3 regimens attained high and equivalent rates of virologic control. Tolerability of regimens containing raltegravir or ritonavir-boosted darunavir was superior to that of the ritonavir-boosted atazanavir regimen.Primary funding sourceNational Institute of Allergy and Infectious Diseases.

Published
2014

20. Leveraging vaccination-induced protective antibodies to define conserved epitopes on influenza N2 neuraminidase

Author

Lei, Ruipeng, primary, Kim, Wooseob, additional, Lv, Huibin, additional, Mou, Zongjun, additional, Scherm, Michael J., additional, Schmitz, Aaron J., additional, Turner, Jackson S., additional, Tan, Timothy J.C., additional, Wang, Yiquan, additional, Ouyang, Wenhao O., additional, Liang, Weiwen, additional, Rivera-Cardona, Joel, additional, Teo, Chuyun, additional, Graham, Claire S., additional, Brooke, Christopher B., additional, Presti, Rachel M., additional, Mok, Chris K.P., additional, Krammer, Florian, additional, Dai, Xinghong, additional, Ellebedy, Ali H., additional, and Wu, Nicholas C., additional

Published
2023
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21. Associations of Muscle Density and Area With Coronary Artery Plaque and Physical Function

Author

Erlandson, Kristine M., primary, Umbleja, Triin, additional, Lu, Michael T., additional, Taron, Jana, additional, Ribaudo, Heather J., additional, Overton, Edgar T., additional, Presti, Rachel M., additional, Haas, David W., additional, Sax, Paul E., additional, Yin, Michael T., additional, Zhai, Bingxue Kris, additional, Louis, Rochelle, additional, Upadhyay, Namrata, additional, Eslami, Parastou, additional, Douglas, Pamela S., additional, Zanni, Markella V., additional, Fitch, Kathleen V., additional, Fulda, Evelynne S., additional, Fichtenbaum, Carl J., additional, Malvestutto, Carlos D., additional, Grinspoon, Steven K., additional, and Brown, Todd T., additional

Published
2023
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24. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study

Author

Cahn, Pedro Enrique, Cassetti, Lidia Isabel, Porteiro Barreira, Norma, Angel, Jonathan Benjamin, de Pokomandy, Alexandra, Harris, Marianne, Rachlis, Anita R., Walmsley, Sharon L., Allavena, Clotilde, Bouchaud, Oliver, Gatey, Caroline, Rami, Agathe, Casari, Salvatore, Di Perri, Giovanni, Lazzarin, Adriano, Maggiolo, Franco, Penco, Giovanni, Quirino, Tiziana, Rizzardini, Giuliano, Andrade-Villanueva, Jaime-Federico, Sierra-Madero, Juan G., Branco, Teresa, Serrao, Rosario, Teofilo, Eugenio JR., Melendez-Rivera, Ivan, Santiago, Lizette, Zorrilla, Carmen D., Belonosova, Elena, Chernova, Oksana E., Pokrovsky, Vadim, Rakhmanova, Aza Gasanovna, Tsybakova, Olga, Voronin, Eugene, Orrell, Catherine, Vally, Tasneem, Farisani, Livhuwani ML., Sebopa, Boitumelo Lucrecia, Barros, Carlos Aguado, Cano Sánchez, Alfredo, Castaño, Manuel, Falcó Ferrer, Vicens, González García, Juan J., Hernandez-Quero, Jose, Negredo Puigmal, Eugenia, Pérez Elías, María Jesús, Podzamczer Palter, Daniel, Portilla, Joaquin Sogorb, Viciana Fernández, Pompeyo, Manosuthi, Weerawat, Ruxrungtham, Kiat, Dockrell, David H., Hay, Phillip E., Johnson, Margaret A., Mackie, Nicola E., Orkin, Chloe M., Taylor, Steve, Bhatti, Laveeza, Brar, Indira, Brennan, Robert Owen, Cade, Jerry L., Casanas, Beata, Casey, Kathleen, Cunningham, Douglas, DeJesus, Edwin, Dietz, Craig, Dretler, Robin Henry, Eron, Joseph J., Jr., Felizarta, Franco Antoni B., Fife, Kenneth H., Hagins, Debbie P., Hoffman-Terry, Margaret, Jain, Mamta, Johnson, Marc Alexander, Kinder, Clifford A., Kumar, Princy N., Lewis, Stanley T., Jr., McDonald, Cheryl Kay, Meza, Armando D., Mounzer, Karam C., Newman, Cheryl L., Osiyemi, Olayemi O., Poblete, Ronald, Presti, Rachel M., Ramgopal, Moti, Rosenstock, Joel, Samuel, Rafik, Sandkovsky, Uriel Sebastian, Shon, Alyssa So Young, Skiest, Daniel J., Sloan, Louis M., Small, Catherine B., Tebas, Pablo, Van Dam, Cornelius N., Hagins, Debbie P, Porteiro, Norma, Walmsley, Sharon, Falcó, Vicenç, Man, Choy Y, Aylott, Alicia, Buchanan, Ann M, Wynne, Brian, Vavro, Cindy, Aboud, Michael, and Smith, Kimberly Y

Published
2017
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25. Spatiotemporal development of the human T follicular helper cell response to Influenza vaccination

Author

Schattgen, Stefan, primary, Turner, Jackson S, additional, Ghonim, Mohamed A, additional, Crawford, Jeremy Chase, additional, Schmitz, Aaron J, additional, Kim, Hyunjin, additional, Zhou, Julian Q, additional, Awad, Walid, additional, Kim, Wooseob, additional, McIntire, Katherine M, additional, Haile, Alem, additional, Klebert, Michael K, additional, Suessen, Teresa, additional, Middleton, William D, additional, Teefey, Sharlene A, additional, Presti, Rachel M, additional, Ellebedy, Ali, additional, and Thomas, Paul, additional

Published
2023
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26. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G, primary, Branche, Angela R, additional, Diemert, David J, additional, Falsey, Ann R, additional, Losada, Cecilia, additional, Baden, Lindsey R, additional, Frey, Sharon E, additional, Whitaker, Jennifer A, additional, Little, Susan J, additional, Kamidani, Satoshi, additional, Walter, Emmanuel B, additional, Novak, Richard M, additional, Rupp, Richard, additional, Jackson, Lisa A, additional, Babu, Tara M, additional, Kottkamp, Angelica C, additional, Luetkemeyer, Anne F, additional, Immergluck, Lilly C, additional, Presti, Rachel M, additional, Bäcker, Martín, additional, Winokur, Patricia L, additional, Mahgoub, Siham M, additional, Goepfert, Paul A, additional, Fusco, Dahlene N, additional, Atmar, Robert L, additional, Posavad, Christine M, additional, Netzl, Antonia, additional, Smith, Derek J, additional, Telu, Kalyani, additional, Mu, Jinjian, additional, McQuarrie, Lisa J, additional, Makowski, Mat, additional, Makhene, Mamodikoe K, additional, Crandon, Sonja, additional, Montefiori, David C, additional, Roberts, Paul C, additional, and Beigel, John H, additional

Published
2023
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27. Rapid Direct Detection of SARS-CoV-2 Aerosols in Exhaled Breath at the Point of Care

Author

Ghumra, Dishit P., primary, Shetty, Nishit, additional, McBrearty, Kevin R., additional, Puthussery, Joseph V., additional, Sumlin, Benjamin J., additional, Gardiner, Woodrow D., additional, Doherty, Brookelyn M., additional, Magrecki, Jordan P., additional, Brody, David L., additional, Esparza, Thomas J., additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Bricker, Traci L., additional, Boon, Adrianus C. M., additional, Yuede, Carla M., additional, Cirrito, John R., additional, and Chakrabarty, Rajan K., additional

Published
2023
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28. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G., primary, Branche, Angela R., additional, Diemert, David J., additional, Falsey, Ann R., additional, Losada, Cecilia, additional, Baden, Lindsey R., additional, Frey, Sharon E., additional, Whitaker, Jennifer A., additional, Little, Susan J., additional, Kamidani, Satoshi, additional, Walter, Emmanuel B., additional, Novak, Richard M., additional, Rupp, Richard, additional, Jackson, Lisa A., additional, Babu, Tara M., additional, Kottkamp, Angelica C., additional, Luetkemeyer, Anne F., additional, Immergluck, Lilly C., additional, Presti, Rachel M., additional, Bäcker, Martín, additional, Winokur, Patricia L., additional, Mahgoub, Siham M., additional, Goepfert, Paul A., additional, Fusco, Dahlene N., additional, Atmar, Robert L., additional, Posavad, Christine M., additional, Netzl, Antonia, additional, Smith, Derek J., additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K., additional, Crandon, Sonja, additional, Montefiori, David C., additional, Roberts, Paul C., additional, and Beigel, John H., additional

Published
2023
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29. Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Author

Rouphael, Nadine G, Branche, Angela R, Diemert, David J, Falsey, Ann R, Losada, Cecilia, Baden, Lindsey R, Frey, Sharon E, Whitaker, Jennifer A, Little, Susan J, Kamidani, Satoshi, Walter, Emmanuel B, Novak, Richard M, Rupp, Richard, Jackson, Lisa A, Babu, Tara M, Kottkamp, Angelica C, Luetkemeyer, Anne F, Immergluck, Lilly C, Presti, Rachel M, and Bäcker, Martín

Subjects
CLINICAL trials, SARS-CoV-2 Omicron variant, IMMUNE response, VACCINES, MESSENGER RNA
Abstract

We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the serological responses compared to a single variant vaccine boost. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G., Branche, Angela R., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Kamidani, Satoshi, Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Atmar, Robert L., Posavad, Christine M., Netzl, Antonia, Smith, Derek J., Telu, Kalyani, Mu, Jinjian, Makowski, Mat, Makhene, Mamodikoe K., Crandon, Sonja, Montefiori, David C., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults.

Published
2023

32. Phenotypic analysis of HIV-1 resistance to CD4 binding site broadly-neutralizing antibodies

Author

Shrader, Hannah, primary, Hait, Sabrina Helmold, additional, Lovelace, Sarah, additional, Kilner, Meaghan, additional, Shen, Chen-Hsiang, additional, Coates, Emily, additional, Gaudinski, Martin, additional, Rothwell, Ro Shauna, additional, Donaghy, Eileen, additional, Roa, Jhoanna, additional, Fichtenbaum, Carl, additional, Santana, Jorge, additional, Presti, Rachel M, additional, Bhatnager, Anjali, additional, Lynch, Rebecca, additional, Tebas, Pablo, additional, Ledgerwood, Julie, additional, Mascola, John, additional, Koup, Richard, additional, and Pegu, Amarendra, additional

Published
2023
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33. Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial

Author

Branche, Angela R, primary, Rouphael, Nadine G, additional, Losada, Cecilia, additional, Baden, Lindsey R, additional, Anderson, Evan J, additional, Luetkemeyer, Anne F, additional, Diemert, David J, additional, Winokur, Patricia L, additional, Presti, Rachel M, additional, Kottkamp, Angelica C, additional, Falsey, Ann R, additional, Frey, Sharon E, additional, Rupp, Richard, additional, Bäcker, Martín, additional, Novak, Richard M, additional, Walter, Emmanuel B, additional, Jackson, Lisa A, additional, Little, Susan J, additional, Immergluck, Lilly C, additional, Mahgoub, Siham M, additional, Whitaker, Jennifer A, additional, Babu, Tara M, additional, Goepfert, Paul A, additional, Fusco, Dahlene N, additional, Atmar, Robert L, additional, Posavad, Christine M, additional, Netzl, Antonia, additional, Smith, Derek J, additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K, additional, Crandon, Sonja, additional, Montefiori, David C, additional, Roberts, Paul C, additional, and Beigel, John H, additional

Published
2023
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34. CD4+T cells exhibit distinct transcriptional phenotypes in the lymph nodes and blood following mRNA vaccination in humans

Author

Borcherding, Nicholas, Kim, Wooseob, Quinn, Michael, Han, Fangjie, Zhou, Julian Q., Sturtz, Alexandria J., Schmitz, Aaron J., Lei, Tingting, Schattgen, Stefan A., Klebert, Michael K., Suessen, Teresa, Middleton, William D., Goss, Charles W., Liu, Chang, Crawford, Jeremy Chase, Thomas, Paul G., Teefey, Sharlene A., Presti, Rachel M., O’Halloran, Jane A., Turner, Jackson S., Ellebedy, Ali H., and Mudd, Philip A.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mRNA vaccination induce robust CD4+T cell responses. Using single-cell transcriptomics, here, we evaluated CD4+T cells specific for the SARS-CoV-2 spike protein in the blood and draining lymph nodes (dLNs) of individuals 3 months and 6 months after vaccination with the BNT162b2 mRNA vaccine. We analyzed 1,277 spike-specific CD4+T cells, including 238 defined using Trex, a deep learning-based reverse epitope mapping method to predict antigen specificity. Human dLN spike-specific CD4+follicular helper T (TFH) cells exhibited heterogeneous phenotypes, including germinal center CD4+TFHcells and CD4+IL-10+TFHcells. Analysis of an independent cohort of SARS-CoV-2-infected individuals 3 months and 6 months after infection found spike-specific CD4+T cell profiles in blood that were distinct from those detected in blood 3 months and 6 months after BNT162b2 vaccination. Our findings provide an atlas of human spike-specific CD4+T cell transcriptional phenotypes in the dLNs and blood following SARS-CoV-2 vaccination or infection.

Published
2024
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36. Persons with HIV Develop Spike-Specific Lymph Node Germinal Center Responses following SARS-CoV-2 Vaccination

Author

Quinn, Michael, primary, Parra-Rodriguez, Luis, additional, Alsoussi, Wafaa B., additional, Ayres, Chapelle, additional, Klebert, Michael K., additional, Liu, Chang, additional, Suessen, Teresa, additional, Scheaffer, Suzanne M., additional, Middleton, William D., additional, Teefey, Sharlene A., additional, Powderly, William G., additional, Diamond, Michael S., additional, Presti, Rachel M., additional, Ellebedy, Ali H., additional, Turner, Jackson S., additional, O’Halloran, Jane A., additional, and Mudd, Philip A., additional

Published
2023
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37. Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial

Author

Branche, Angela R., primary, Rouphael, Nadine G., additional, Losada, Cecilia, additional, Baden, Lindsey R., additional, Anderson, Evan J., additional, Luetkemeyer, Anne F., additional, Diemert, David J., additional, Winokur, Patricia L., additional, Presti, Rachel M., additional, Kottkamp, Angelica C., additional, Falsey, Ann R., additional, Frey, Sharon E., additional, Rupp, Richard, additional, Bäcker, Martín, additional, Novak, Richard M., additional, Walter, Emmanuel B., additional, Jackson, Lisa A., additional, Little, Susan J., additional, Immergluck, Lilly C., additional, Mahgoub, Siham M., additional, Whitaker, Jennifer A., additional, Babu, Tara M., additional, Goepfert, Paul A., additional, Fusco, Dahlene N., additional, Atmar, Robert L., additional, Posavad, Christine M., additional, Netzl, Antonia, additional, Smith, Derek J., additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K., additional, Crandon, Sonja, additional, Montefiori, David C., additional, Roberts, Paul C., additional, and Beigel, John H., additional

Published
2023
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38. SARS-CoV-2 booster vaccination rescues attenuated IgG1 memory B cell response in primary antibody deficiency patients

Author

Lin, Frank J., primary, Doss, Alexa Michelle Altman, additional, Davis-Adams, Hannah G., additional, Adams, Lucas J., additional, Hanson, Christopher H., additional, VanBlargan, Laura A., additional, Liang, Chieh-Yu, additional, Chen, Rita E., additional, Monroy, Jennifer Marie, additional, Wedner, H. James, additional, Kulczycki, Anthony, additional, Mantia, Tarisa L., additional, O’Shaughnessy, Caitlin C., additional, Raju, Saravanan, additional, Zhao, Fang R., additional, Rizzi, Elise, additional, Rigell, Christopher J., additional, Dy, Tiffany Biason, additional, Kau, Andrew L., additional, Ren, Zhen, additional, Turner, Jackson S., additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Fremont, Daved H., additional, Kendall, Peggy L., additional, Ellebedy, Ali H., additional, Mudd, Philip A., additional, Diamond, Michael S., additional, Zimmerman, Ofer, additional, and Laidlaw, Brian J., additional

Published
2022
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40. SARS-CoV-2 Omicron boosting induces de novo B cell response in humans

Author

Alsoussi, Wafaa B., primary, Malladi, Sameer K., additional, Zhou, Julian Q., additional, Liu, Zhuoming, additional, Ying, Baoling, additional, Kim, Wooseob, additional, Schmitz, Aaron J., additional, Lei, Tingting, additional, Horvath, Stephen C., additional, Sturtz, Alexandria J., additional, McIntire, Katherine M., additional, Evavold, Birk, additional, Han, Fangjie, additional, Scheaffer, Suzanne M., additional, Fox, Isabella F., additional, Parra-Rodriguez, Luis, additional, Nachbagauer, Raffael, additional, Nestorova, Biliana, additional, Chalkias, Spyros, additional, Farnsworth, Christopher W., additional, Klebert, Michael K., additional, Pusic, Iskra, additional, Strnad, Benjamin S., additional, Middleton, William D., additional, Teefey, Sharlene A., additional, Whelan, Sean P.J., additional, Diamond, Michael S., additional, Paris, Robert, additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Turner, Jackson S., additional, and Ellebedy, Ali H., additional

Published
2022
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41. Loss of Pfizer (BNT162b2) Vaccine-Induced Antibody Responses against the SARS-CoV-2 Omicron Variant in Adolescents and Adults

Author

Gupta, Sneh Lata, primary, Mantus, Grace, additional, Manning, Kelly E., additional, Ellis, Madison, additional, Patel, Mit, additional, Ciric, Caroline Rose, additional, Lu, Austin, additional, Turner, Jackson S., additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Joshi, Devyani Jaideep, additional, Ellebedy, Ali H., additional, Anderson, Evan J., additional, Rostad, Christina A., additional, Suthar, Mehul S., additional, and Wrammert, Jens, additional

Published
2022
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42. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C.S., Rostad, Christina A., Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Lee, Marina, Nayak, Seema U., Montefiori, David C., Makowski, Mat, Smith, Derek J., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

BackgroundProtection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines.MethodsThis phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID50) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination.ResultsFrom March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907).ConclusionsHigher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines.Clinicaltrials.govNCT05289037

Published
2022

43. Reactogenicity of the Messenger RNA SARS–CoV‐2 Vaccines Associated With Immunogenicity in Patients With Autoimmune and Inflammatory Disease

Author

Yang, Monica M., primary, Taylor, Kimberly E., additional, Paez, Diana, additional, Carividi, Alex, additional, Demissie, Emanuel, additional, Pawar, Niti, additional, El‐Qunni, Alia A., additional, McMorrow, Lily E., additional, Schriefer, Rebecca E., additional, Huang, Katherine, additional, Kinnett, Baylee, additional, Klebert, Michael, additional, Haile, Alem, additional, O'Halloran, Jane A., additional, Presti, Rachel M., additional, Kim, Wooseob, additional, Ellebedy, Ali H., additional, Ciorba, Matthew A., additional, Paley, Michael A., additional, Deepak, Parakkal, additional, Kim, Alfred H. J., additional, Katz, Patricia, additional, Matloubian, Mehrdad, additional, Nakamura, Mary, additional, and Gensler, Lianne S., additional

Published
2022
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46. Su1481: IMPACT OF IMMUNOSUPPRESSIVE THERAPIES ON ANTIBODY DECAY FOLLOWING MRNA VACCINATION TO SARS-COV-2 IN A PROSPECTIVE COHORT OF PATIENTS WITH CHRONIC INFLAMMATORY DISEASES

Author

Deepak, Parakkal, primary, Kim, Wooseob, additional, Paley, Michael, additional, Yang, Monica, additional, Burdess, Samantha, additional, Carvidi, Alexander B., additional, Demissie, Emanuel, additional, El-Qunni, Alia A., additional, Haile, Alem, additional, Huang, Katherine, additional, Escudero, Guadalupe Oliva, additional, McMorrow, Lily E., additional, Paez, Diana, additional, Pawar, Niti, additional, Perantie, Dana C., additional, Schriefer, Rebecca E., additional, Sides, Shannon E., additional, Thapa, Mahima, additional, Gergely, Maté, additional, Akuse, Sewuese E., additional, Klebert, Michael, additional, Mitchell, Lynne, additional, Nix, Billy D., additional, Graf, Jonathan, additional, Taylor, Kimberly E., additional, Chahin, Salim, additional, Ciorba, Matthew A., additional, Katz, Patricia, additional, Matloubian, Mehrdad, additional, O'Halloran, Jane A., additional, Presti, Rachel M., additional, Wu, Gregory F., additional, Gensler, Lianne S., additional, Nakamura, Mary C., additional, Ellebedy, Ali H., additional, and Kim, Alfred H., additional

Published
2022
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48. SARS-CoV-2 mRNA vaccination elicits a robust and persistent T follicular helper cell response in humans

Author

Mudd, Philip A., primary, Minervina, Anastasia A., additional, Pogorelyy, Mikhail V., additional, Turner, Jackson S., additional, Kim, Wooseob, additional, Kalaidina, Elizaveta, additional, Petersen, Jan, additional, Schmitz, Aaron J., additional, Lei, Tingting, additional, Haile, Alem, additional, Kirk, Allison M., additional, Mettelman, Robert C., additional, Crawford, Jeremy Chase, additional, Nguyen, Thi H.O., additional, Rowntree, Louise C., additional, Rosati, Elisa, additional, Richards, Katherine A., additional, Sant, Andrea J., additional, Klebert, Michael K., additional, Suessen, Teresa, additional, Middleton, William D., additional, Wolf, Joshua, additional, Teefey, Sharlene A., additional, O’Halloran, Jane A., additional, Presti, Rachel M., additional, Kedzierska, Katherine, additional, Rossjohn, Jamie, additional, Thomas, Paul G., additional, Ellebedy, Ali H., additional, Estepp, Jeremie H., additional, Schultz-Cherry, Stacey, additional, McGargill, Maureen A., additional, Gaur, Aditya, additional, Hoffman, James, additional, Mori, Motomi, additional, Tang, Li, additional, Tuomanen, Elaine, additional, Webby, Richard, additional, Hayden, Randall T., additional, Hakim, Hana, additional, Hijano, Diego R., additional, Allison, Kim J., additional, Allen, E. Kaitlynn, additional, Bajracharya, Resha, additional, Awad, Walid, additional, Van de Velde, Lee-Ann, additional, Clark, Brandi L., additional, Wilson, Taylor L., additional, Souquette, Aisha, additional, Castellaw, Ashley, additional, Dallas, Ronald H., additional, Gowen, Ashleigh, additional, Fabrizio, Thomas P., additional, Lin, Chun-Yang, additional, Brice, David C., additional, Cherry, Sean, additional, Roubidoux, Ericka Kirkpatrick, additional, Cortez, Valerie, additional, Freiden, Pamela, additional, Wohlgemuth, Nicholas, additional, and Whitt, Kendall, additional

Published
2022
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49. A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES Probiotic in People With HIV on Antiretroviral Therapy

Author

Presti, Rachel M, primary, Yeh, Eunice, additional, Williams, Brett, additional, Landay, Alan, additional, Jacobson, Jeffrey M, additional, Wilson, Cara, additional, Fichtenbaum, Carl J, additional, Utay, Netanya S, additional, Dube, Michael P, additional, Klingman, Karin L, additional, Estes, Jacob D, additional, Flynn, Jacob K, additional, Loftin, Amanda, additional, Brenchley, Jason M, additional, Andrade, Adriana, additional, Kitch, Douglas W, additional, and Overton, Edgar T, additional

Published
2021
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