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Clinical Trial

Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial

Youyi Fong et al. Clin Infect Dis. .

Abstract

For COVAIL recipients of a coronavirus disease 2019 (COVID-19) Sanofi booster vaccine, neutralizing antibody titers were assessed as a correlate of risk (CoR) of COVID-19. Peak and exposure-proximal titers were inverse CoRs with covariate-adjusted hazard ratios (95% confidence intervals) 0.30 (0.11, 0.78) and 0.25 (0.07, 0.85) per 10-fold increase in weighted average titer.

Trial registration: ClinicalTrials.gov NCT05289037.

Keywords: COVID-19 booster; Omicron; correlate of risk; exposure-proximal titer; variant vaccine booster.

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Conflict of interest statement

Potential conflicts of interest . L. D. received support from Novo Nordisk (NN) via a philanthropic gift to UC Berkeley that supported conference/meeting-related travel she took in 2021 and 2022, as well as supported her tuition during her PhD from 9/2020 to 5/2023. S. C. reports grant support to her institution from NIH/NIAID for the present manuscript. N. G. R. received NIH funding to her institution for the present manuscript and her institution received funds for her to conduct research in the past 36 months from Merck, Sanofi, Pfizer, Vaccine Company, Immorna, Quidel and Lilly. In the past 36 months, N. G. R. received consulting fees from Krog; payment for virology education; support from Sanofi and Moderna to attend meetings and/or travel; participated on Moderna, Sanofi, Seqirus, Pfizer advisory boards; served on EMMES, ICON, BARDA, CyanVac Micron Safety Committees; served in advisory roles on ARLG, TMRC, CDC-Pertussis challenge, served (and is currently) an Associate Editor at Clinical Infectious Diseases; and her institution received equipment, materials, drugs, medical writing, gifts or other services from the Georgia Research Alliance. A. R. B. received support for the present manuscript from Merck, and received grants or contracts from Moderna, Pfizer, Cyanvac, and Vaccitech in the past 36 months. In the past 36 months, she also received consulting fees from GSK, Moderna, Sanofi, and Novavax; and payment for a speaker role at learning lounges for IDWeek from Moderna and Sanofi.

D. J. D. received an award to his institution from Leidos Biomed/NIH to conduct the clinical trial reported in the manuscript. A. R. F. reports in the past 36 months research grants to her institution from Janssen, Merck, CyanVac, VaxCo, BioFire Diagnostics, Moderna, Pfizer, and AstraZeneca; consulting fees from ADMA Biologics, GSK, Sanofi Pasteur, and Merck; support for attending meetings and/or travel from GSK, Moderna, and Sanofi Pasteur; and participation on a Novavax Data Safety Monitoring Board or Advisory Board. L. R. B received an NIH grant to his institution for the present manuscript; reports grants from NIH, Harvard Medical School, Wellcome Trust, and the Gates Foundation to his institution in the past 36 months; and participated in an NIH DSMB meeting in the past 36 months and an FDA AMDAC Committee in the past 36 months. L. R. B. is involved in human immunodeficiency virus (HIV) and SARS-CoV-2 vaccine clinical trials conducted in collaboration with the NIH, HIV Vaccine Trials Network (HVTN), COVID Vaccine Prevention Network (CoVPN), International AIDS Vaccine Initiative (IAVI), Crucell/Janssen, Moderna, Military HIV Research Program (MHRP), the Gates Foundation, and Harvard Medical School.

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  • Neutralizing antibody immune correlates in COVAIL trial recipients of an mRNA second COVID-19 vaccine boost.
    Zhang B, Fong Y, Dang L, Fintzi J, Chen S, Wang J, Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Graciaa DS, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Yu C, Magaret CA, Molitor C, Borate B, Busch S, Benkeser D, Netzl A, Smith DJ, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Mu J, Makowski M, Makhene MK, Nayak SU, Roberts PC, Gilbert PB, Follmann D; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Zhang B, et al. Nat Commun. 2025 Jan 17;16(1):759. doi: 10.1038/s41467-025-55931-w. Nat Commun. 2025. PMID: 39824819 Free PMC article. Clinical Trial.

References

    1. Branche AR, Rouphael NG, Diemert DJ, et al. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial. Nat Med 2023; 29:2334–46. - PMC - PubMed
    1. Fong Y, McDermott AB, Benkeser D, et al. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial. Nat Microbiol 2022; 7:1996–2010. - PMC - PubMed
    1. He Z, Fong Y. Maximum diversity weighting for biomarkers with application in HIV-1 vaccine studies. Stat Med 2019; 38:3936–46. - PMC - PubMed
    1. Johns Hopkins Coronavirus Resource Center . Region—United States. Available at: https://coronavirus.jhu.edu/region/united-states. Accessed 12 March 2024. Last updated 10 March 2023.
    1. Gilbert PB, Fong Y, Kenny A, Carone M. A controlled effects approach to assessing immune correlates of protection. Biostatistics 2023; 24:850–65. - PMC - PubMed

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