Evidence for antibody as a protective correlate for COVID-19 vaccines
Open accessPreprint — published as 10.1016/j.vaccine.2021.05.063 · Paper page
Abstract
Though eleven novel COVID-19 vaccines have demonstrated efficacy, additional affordable, scalable, and deliverable vaccines are needed to meet unprecedented global demand. With placebo-controlled efficacy trials becoming infeasible due to the roll out of licensed vaccines, a correlate of protection is urgently needed to provide a path for regulatory approval of novel vaccines. To assess whether antibody titers may reasonably predict efficacy, we evaluated the relationship between efficacy and in vitro neutralizing and binding antibodies of 7 vaccines for which sufficient data have been generated. Once calibrated to titers of human convalescent sera reported in each study, a robust correlation was seen between neutralizing titer and efficacy (ρ= 0.79) and binding antibody titer and efficacy (ρ = 0.93), despite geographically diverse study populations subject to different forces of infection and circulating variants, and use of different endpoints, assays, convalescent sera panels and manufacturing platforms. This correlation is strengthened by substituting post-hoc analyses for efficacy against the ancestral strain (D614G), where available. Together with an accumulating body of evidence from natural history studies and animal models, these results support the use of post-immunization antibody titers as the basis for establishing a correlate of protection for COVID-19 vaccines.
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An initial analysis of trials of seven vaccines suggested anti-S antibody is a reasonable correlate of protection, with rank correlations of 0.79 between neutralizing antibody titre and efficacy and 0.93 between anti-S binding antibody titre and efficacy after a complete vaccine series.
“An initial analysis from trials of seven current vaccines has suggested that anti-S antibody is a reasonable correlate of protection — a robust correlation was reported between NAb titre and vaccine efficacy (rank correlation rs = 0.79) and between anti-S binding antibody titre and efficacy (rs = 0.93) after a complete vaccine series (one or two doses, depending on the vaccine)97.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [97]
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References 16 · Cited by 870
- Authors
- Earle, K. A., Ambrosino, D. M., Fiore-Gartland, A., Goldblatt, D., Gilbert, P. B., Siber, G. R., Dull, P., & Plotkin, S. A.
- Affiliations
- Gates Foundation (US)
- Fred Hutch Cancer Center (US)
- University College London (GB)
- University of Pennsylvania (US)
- Corresponding author
- Dull, Peter
- ORCID
- Venue
- Vaccine
- Publisher
- openRxiv
- Published
- 2021-03-20
- Volume
- 39
- Issue
- 32
- Pages
- 4423-4428
- ISSN
- 0264-410X (ISSN-L)
- PMC
- PMC8142841
- OpenAlex
- W3164547793
- Cited by
- 870
- References
- 16
- Citations by year
- 2026: 41 · 2025: 65 · 2024: 94 · 2023: 167 · 2022: 351 · 2021: 149 · 2020: 1
- FWCI
- 60.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Vaccine (publishedVersion, cc-by)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Bill and Melinda Gates Foundation
- National Institute of Allergy and Infectious Diseases (UM1AI068635, R37AI054165)
- 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
- COVID-19 vaccines, correlates of protection, antibody titers, neutralizing antibodies, binding antibodies, vaccine efficacy, convalescent sera, SARS-CoV-2, vaccine development
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Serotherapy, Animals, Antibodies, Viral, Humans, Immunization, Passive, Antibodies, Neutralizing
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