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6 results on '"the Immune Assays Team"'

1. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

Author

David Benkeser, Youyi Fong, Holly E. Janes, Elizabeth J. Kelly, Ian Hirsch, Stephanie Sproule, Ann Marie Stanley, Jill Maaske, Tonya Villafana, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Victor Ayala, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, Lindsay N. Carpp, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Margaret Brewinski Isaacs, Mamodikoe Makhene, Tina Tong, Merlin L. Robb, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Corey Hoffman, Ann R. Falsey, Magdalena Sobieszczyk, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert, on behalf of the AstraZeneca AZD1222 Clinical Study Group, the Immune Assays Team, and the United States Government (USG)/CoVPN Biostatistics Team

Subjects
Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19). These analyses of SARS-CoV-2 negative participants were based on case-cohort sampling of vaccine recipients (33 COVID-19 cases by 4 months post dose two, 463 non-cases). The adjusted hazard ratio of COVID-19 was 0.32 (95% CI: 0.14, 0.76) per 10-fold increase in spike IgG concentration and 0.28 (0.10, 0.77) per 10-fold increase in nAb ID50 titer. At nAb ID50 below the limit of detection (< 2.612 IU50/ml), 10, 100, and 270 IU50/ml, vaccine efficacy was −5.8% (−651%, 75.6%), 64.9% (56.4%, 86.9%), 90.0% (55.8%, 97.6%) and 94.2% (69.4%, 99.1%). These findings provide further evidence towards defining an immune marker correlate of protection to help guide regulatory/approval decisions for COVID-19 vaccines.

Published
2023
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2. Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial

Author

Lindsay N. Carpp, Ollivier Hyrien, Youyi Fong, David Benkeser, Sanne Roels, Daniel J. Stieh, Ilse Van Dromme, Griet A. Van Roey, Avi Kenny, Ying Huang, Marco Carone, Adrian B. McDermott, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Obrimpong Amoa-Awua, Manjula Basappa, Britta Flach, Bob C. Lin, Christopher Moore, Mursal Naisan, Muhammed Naqvi, Sandeep Narpala, Sarah O’Connell, Allen Mueller, Leo Serebryannyy, Mike Castro, Jennifer Wang, Christos J. Petropoulos, Alex Luedtke, Yiwen Lu, Chenchen Yu, Michal Juraska, Nima S. Hejazi, Daniel N. Wolfe, Jerald Sadoff, Glenda E. Gray, Beatriz Grinsztejn, Paul A. Goepfert, Linda-Gail Bekker, Aditya H. Gaur, Valdilea G. Veloso, April K. Randhawa, Michele P. Andrasik, Jenny Hendriks, Carla Truyers, An Vandebosch, Frank Struyf, Hanneke Schuitemaker, Macaya Douoguih, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert, On behalf of the Immune Assays Team, the Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team, and the United States Government (USG)/CoVPN Biostatistics Team

Subjects
Science
Abstract

Abstract Assessment of immune correlates of severe COVID-19 has been hampered by the low numbers of severe cases in COVID-19 vaccine efficacy (VE) trials. We assess neutralizing and binding antibody levels at 4 weeks post-Ad26.COV2.S vaccination as correlates of risk and of protection against severe-critical COVID-19 through 220 days post-vaccination in the ENSEMBLE trial (NCT04505722), constituting ~4.5 months longer follow-up than our previous correlates analysis and enabling inclusion of 42 severe-critical vaccine-breakthrough cases. Neutralizing antibody titer is a strong inverse correlate of severe-critical COVID-19, with estimated hazard ratio (HR) per 10-fold increase 0.35 (95% CI: 0.13, 0.90). In a multivariable model, HRs are 0.31 (0.11, 0.89) for neutralizing antibody titer and 1.22 (0.49, 3.02) for anti-Spike binding antibody concentration. VE against severe-critical COVID-19 rises with neutralizing antibody titer: 63.1% (95% CI: 40.0%, 77.3%) at unquantifiable [

Published
2024
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3. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Youyi Fong, Yunda Huang, David Benkeser, Lindsay N. Carpp, Germán Áñez, Wayne Woo, Alice McGarry, Lisa M. Dunkle, Iksung Cho, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hutter, Maryam Keshtkar-Jahromi, Tatiana H. Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert, Immune Assays Team, Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team, and United States Government (USG)/CoVPN Biostatistics Team

Subjects
Science
Abstract

Authors have previously reported on the efficacy and safety of the recombinant spike protein nanoparticle vaccine, NVX-CoV2373, in healthy adults. In this work, they assess anti-spike binding IgG, anti-RBD binding IgG and neutralising antibody titer as correlates of risk and protection against COVID-19.

Published
2023
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4. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Youyi Fong, Yunda Huang, David Benkeser, Lindsay N. Carpp, Germán Áñez, Wayne Woo, Alice McGarry, Lisa M. Dunkle, Iksung Cho, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hutter, Maryam Keshtkar-Jahromi, Tatiana H. Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert, Immune Assays Team, Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team, and United States Government (USG)/CoVPN Biostatistics Team

Subjects
Science
Published
2023
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5. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial

Author

Michele P. Andrasik, Weiping Deng, Yiwen Lu, Bob C. Lin, Ruben O. Donis, Youyi Fong, Mira Baron, Lindsay N. Carpp, Lars W. P. van der Laan, Immune Assays Team, Adrian B. McDermott, Karen Martins, Lindsey R. Baden, Flora Castellino, James G. Kublin, Luis De La Cruz, Honghong Zhou, Chuong Huynh, Rolando Pajon, Amanda Eaton, David Benkeser, Mark Kutner, Dean Follmann, Marcella Sarzotti-Kelsoe, CoVPN Biostatistics Team, Hana M. El Sahly, Charlene McDanal, Jacqueline Miller, Christopher R. Houchens, Nima S. Hejazi, Kathleen M. Neuzil, Spyros A. Kalams, Bhavesh Borate, Coronavirus Efficacy (Cove) Team, David C. Montefiori, Lakshmi Jayashankar, Colleen F. Kelley, Richard A. Koup, Britta Flach, Peter B. Gilbert, Lawrence Corey, and Chenchen Yu

Subjects
medicine.medical_specialty, biology, business.industry, Hazard ratio, Vaccine efficacy, Gastroenterology, Article, Neutralization, Serology, Titer, Internal medicine, medicine, biology.protein, Cumulative incidence, Antibody, Neutralizing antibody, business
Abstract

BackgroundIn the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection.MethodsThrough case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80). Participants with no evidence of previous SARS-CoV-2 infection were included. Cox regression assessed in vaccine recipients the association of each Day 29 or 57 serologic marker with COVID-19 through 126 or 100 days of follow-up, respectively, adjusting for risk factors.ResultsDay 57 Spike IgG, RBD IgG, cID50, and cID80 neutralization levels were each inversely correlated with risk of COVID-19: hazard ratios 0.66 (95% CI 0.50, 0.88; p=0.005); 0.57 (0.40, 0.82; p=0.002); 0.42 (0.27, 0.65; pConclusionsBinding and neutralizing antibodies correlated with COVID-19 risk and vaccine efficacy and likely have utility in predicting mRNA-1273 vaccine efficacy against COVID-19.Trial registration numberCOVEClinicalTrials.govnumber,NCT04470427

Published
2021
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6. Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial

Author

Bo Zhang, Youyi Fong, Jonathan Fintzi, Eric Chu, Holly E. Janes, Avi Kenny, Marco Carone, David Benkeser, Lars W. P. van der Laan, Weiping Deng, Honghong Zhou, Xiaowei Wang, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Haiyan Chen, Isabel Reeder, Lindsay N. Carpp, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Chuong Huynh, Carl J. Fichtenbaum, Spyros Kalams, Cynthia L. Gay, Michele P. Andrasik, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Frances Priddy, Rituparna Das, Bethany Girard, Hana M. El Sahly, Lindsey R. Baden, Thomas Jones, Ruben O. Donis, Richard A. Koup, Peter B. Gilbert, Dean Follmann, On behalf of the United States Government (USG) COVID-19 Immune Assays Team, Moderna, Inc. Team, Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team, and USG/CoVPN Biostatistics Team

Subjects
Science
Abstract

Abstract In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.1 Spike-specific bAbs and nAbs as CoRs and as correlates of booster efficacy in COVE. For naive individuals, bAbs and nAbs inversely correlate with Omicron COVID-19: hazard ratios (HR) per 10-fold marker increase (95% confidence interval) are 0.16 (0.03, 0.79) and 0.31 (0.10, 0.96), respectively. In non-naive individuals the analogous results are similar: 0.15 (0.04, 0.63) and 0.28 (0.07, 1.08). For naive individuals, three vs two-dose booster efficacy correlates with predicted nAb titer at exposure, with estimates -8% (-126%, 48%), 50% (25%, 67%), and 74% (49%, 87%), at 56, 251, and 891 Arbitrary Units/ml. These results support the continued use of antibody as a surrogate endpoint.

Published
2024
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