The DOI matches its Crossref record; 50 of the 50 references it cites were found in a registry or an index.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial
Open accessPublished version of a preprint
Abstract
Antibody levels predict vaccine efficacy: Symptomatic COVID-19 infection can be prevented by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. A “correlate of protection” is a molecular biomarker to measure how much immunity is needed to fight infection and is key for successful global immunization programs. Gilbert et al . determined that antibodies are the correlate of protection in vaccinated individuals enrolled in the Moderna COVE phase 3 clinical trial (see the Perspective by Openshaw). By measuring binding and neutralizing antibodies against the viral spike protein, the authors found that the levels of both antibodies correlated with the degree of vaccine efficacy. The higher the antibody level, the greater the protection afforded by the messenger RNA (mRNA) vaccine. Antibody levels that predict mRNA vaccine efficacy can therefore be used to guide vaccine regimen modifications and support regulatory approvals for a broader spectrum of the population. —PNK
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“Neutralizing antibodies in the sera of the participants will be assessed since they have been identified as one of the key parameters correlating with the observed protective efficacy of the first generation SARS-CoV-2 mRNA vaccine CVnCoV27, and a licensed COVID-19 mRNA vaccine28.”
From Efficacy of an unmodified bivalent mRNA vaccine against SARS-CoV-2 variants in female small animal models (2023) · cites this paper as [28]
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Baden, L. R., El Sahly, H. M., Essink, B., Kotloff, K., Frey, S., Novak, R., Diemert, D., Spector, S. A., Rouphael, N., Creech, C. B., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2035389 · Cited by 10,119
Self-citationCryo-EM structure of the 2019-nCoV spike in the prefusion conformation
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Sensitivity analysis in observational research: Introducing the E-value
VanderWeele, T. J., & Ding, P. (2017) · Annals of Internal Medicine · doi:10.7326/m16-2607 · Cited by 6,350
Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor
Lan, J., Ge, J., Yu, J., Shan, S., Zhou, H., Fan, S., Zhang, Q., Shi, X., Wang, Q., Zhang, L., et al. (2020) · Nature · doi:10.1038/s41586-020-2180-5 · Cited by 5,983
Self-citationVoysey, M., Clemens, S. A. C., Madhi, S. A., Weckx, L. Y., Folegatti, P. M., Aley, P. K., Angus, B., Baillie, V. L., Barnabas, S. L., Bhorat, Q. E., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(20)32661-1 · Cited by 4,616
Khoury, D. S., Cromer, D., Reynaldi, A., Schlub, T. E., Wheatley, A. K., Juno, J. A., Subbarao, K., Kent, S. J., Triccas, J. A., & Davenport, M. P. (2021) · Nature Medicine · doi:10.1038/s41591-021-01377-8 · Cited by 3,742
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Research works printed but not linked: 5
- Moderna “Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June” (press release 25 May 2021); https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine.
- S. A. Plotkin P. B. Gilbert in Plotkin’s Vaccines S. A. Plotkin W. A. Orenstein P. A. Offit K. M. Edwards Eds. (Elsevier seventh ed. 2018) chap. 3.
- Regeneron “Phase 3 Prevention Trial Showed 81% Reduced Risk of Symptomatic SARS-CoV-2 Infections with Subcutaneous Administration of REGEN-COV™ (casirivimab with imdevimab)” (press release 12 April 2021); https://investor.regeneron.com/news-releases/news-release-details/phase-3-prevention-trial-showed-81-reduced-risk-symptomatic-sars.
- 10.1016/S0140-6736(21)02046-8 · DOI
- P. H. Westfall S. S. Young Resampling-Based Multiple Testing: Examples and Methods for P-Value Adjustment vol. 279 of Wiley Series in Probability and Statistics (Wiley 1993).
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Natural and Hybrid Immunity Following Four COVID-19 Waves in a South African CohortPreprint
Zar, H. J., MacGinty, R. P., Workman, L., Botha, M., Johnson, M., Hunt, A., Burd, T., Nicol, M. P., Flasche, S., Quilty, B. J., et al. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4132330
Metadata
- Authors
- Gilbert, P. B., Montefiori, D. C., McDermott, A. B., Fong, Y., Benkeser, D., Deng, W., Zhou, H., Houchens, C. R., Martins, K., Jayashankar, L., Castellino, F., Flach, B., Lin, B. C., O’Connell, S., McDanal, C., Eaton, A., Sarzotti-Kelsoe, M., Lu, Y., Yu, C., Borate, B., van der Laan, L. W. P., Hejazi, N. S., Huynh, C., Miller, J., El Sahly, H. M., Baden, L. R., Baron, M., De La Cruz, L., Gay, C., Kalams, S., Kelley, C. F., Andrasik, M. P., Kublin, J. G., Corey, L., Neuzil, K. M., Carpp, L. N., Pajon, R., Follmann, D., Donis, R. O., Koup, R. A., Immune Assays Team§, Moderna, I. T., Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§, & United States Government (USG)/CoVPN Biostatistics Team§
- Affiliations
- University of Washington (US)
- Duke University (US)
- National Institutes of Health (US)
- Fred Hutch Cancer Center (US)
- Emory University (US)
- Moderna Therapeutics (United States) (US)
- Biomedical Advanced Research and Development Authority (US)
- Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
- Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
- Brigham and Women's Hospital (US)
- Palm Beach Research Center (US)
- Keystone Vitalink Research, Greenville, SC, USA.
- University of North Carolina at Chapel Hill (US)
- Vanderbilt University Medical Center (US)
- University of Maryland, Baltimore (US)
- Moderna, Inc., Cambridge, MA, USA.
- Biomedical Advanced Research and Development Authority, Washington, DC, USA.
- Corresponding author
- Gilbert, Peter B.
- Montefiori, David C.
- McDermott, Adrian B.
- Koup, Richard A.
- ORCID
- Gilbert, Peter B.
- Montefiori, David C.
- McDermott, Adrian B.
- Fong, Youyi
- Benkeser, David
- Deng, Weiping
- Houchens, Christopher R.
- Martins, Karen
- Jayashankar, Lakshmi
- Castellino, Flora
- Lin, Bob C.
- O’Connell, Sarah
- McDanal, Charlene
- Eaton, Amanda
- Lu, Yiwen
- Yu, Chenchen
- Borate, Bhavesh
- Hejazi, Nima S.
- Miller, Jacqueline
- El Sahly, Hana M.
- Baden, Lindsey R.
- Baron, Mira
- Gay, Cynthia
- Kalams, Spyros
- Kelley, Colleen F.
- Andrasik, Michele P.
- Kublin, James G.
- Corey, Lawrence
- Neuzil, Kathleen M.
- Carpp, Lindsay N.
- Follmann, Dean
- Donis, Ruben O.
- Koup, Richard A.
- Venue
- Science
- Published
- 2022-01-07
- Volume
- 375
- Issue
- 6576
- Pages
- 43-50
- ISSN
- 0036-8075 (ISSN-L)
- 1095-9203
- PMC
- PMC8366808
- OpenAlex
- W3217661335
- Cited by
- 1,137
- References
- 47
- Citations by year
- 2026: 65 · 2025: 114 · 2024: 197 · 2023: 278 · 2022: 412
- FWCI
- 123.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Science (publishedVersion, cc-by)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (submittedVersion, cc-by-nc-nd)
- Funders
- Wellcome Trust
- National Institutes of Health (1s10od028685-01, UL1TR002384)
- National Institute of Allergy and Infectious Diseases (S10AI174104, U01AI068635, UM1AI068614, UM1AI068635, UM1AI148575, UM1AI069476, R37AI054165, UM1AI148684, UM1AI069412)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Keywords
- mRNA-1273 vaccine, COVID-19 vaccine efficacy, SARS-CoV-2, neutralizing antibodies, binding antibodies, correlates of protection, vaccine immunogenicity, vaccine approval
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