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Cited by 870SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research Studiesvaccines and immunoinformatics approaches

Evidence for antibody as a protective correlate for COVID-19 vaccines

Open access
Earle, Kristen A., Ambrosino, Donna M., Fiore-Gartland, Andrew, Goldblatt, David, Gilbert, Peter B., Siber, George R., Dull, Peter, Plotkin, Stanley A.·2021·Vaccine
DOI 10.1016/j.vaccine.2021.05.063PMC PMC8142841

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Abstract

A correlate of protection (CoP) is urgently needed to expedite development of additional COVID-19 vaccines to meet unprecedented global demand. To assess whether antibody titers may reasonably predict efficacy and serve as the basis of a CoP, 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. Together with 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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  • The neutralization level is highly predictive of immune protection.

    “Recently, Khoury et al.20 and Earle et al.21 determined that the neutralization level is highly predictive of immune protection in comparing population values from vaccine efficacy and immunogenicity trials.”

    From Covid-19 Breakthrough Infections in Vaccinated Health Care Workers (2021) · cites this paper as [21]

  • Neutralization of wild type SARS-CoV-2 has been shown to predict the effectiveness of vaccines against variants.

    “However, while neutralization of wild type SARS-CoV-2 has been shown to predict the effectiveness of vaccines against variants (Earle et al., 2021; Khoury et al., 2021)”

    From mRNA-based COVID-19 vaccine boosters induce neutralizing immunity against SARS-CoV-2 Omicron variant (2022) · cites this paper as Earle et al., 2021

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Cites

  • An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

    Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022483 · Cited by 3,237 · cited 1× · see citing works

    “This suggests either relatively low neutralization assay sensitivity or non-neutralizing antibodies and T cell responses may be functionally important, which is supported by the evidence that binding antibody titers appear robust at the same post-Dose 1 time points [11,12] and that Fc functional antibody responses pla…”

  • Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant

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    “351 by vaccinated sera corresponds to a reduction in efficacy [10,14].”

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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
Elsevier BV
Published
2021-07
Volume
39
Issue
32
Pages
4423-4428
ISSN
0264-410X (ISSN-L)
DOI
10.1016/j.vaccine.2021.05.063
PMC
PMC8142841
OpenAlex
W3164547793
Cited by
870
References
2
Citations by year
2026: 41 · 2025: 65 · 2024: 94 · 2023: 167 · 2022: 351 · 2021: 149 · 2020: 1
FWCI
60.42
Type
journal article
Language
en
Open access
Licence
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 & Melinda Gates Foundation
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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