Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

Author:

Gilbert Peter B.123ORCID,Montefiori David C.4ORCID,McDermott Adrian B.5ORCID,Fong Youyi12,Benkeser David6,Deng Weiping7,Zhou Honghong7,Houchens Christopher R.8ORCID,Martins Karen8ORCID,Jayashankar Lakshmi8ORCID,Castellino Flora8,Flach Britta5,Lin Bob C.5,O’Connell Sarah5,McDanal Charlene4,Eaton Amanda4ORCID,Sarzotti-Kelsoe Marcella4,Lu Yiwen1,Yu Chenchen1,Borate Bhavesh1,van der Laan Lars W. P.1,Hejazi Nima S.19,Huynh Chuong8,Miller Jacqueline7ORCID,El Sahly Hana M.10ORCID,Baden Lindsey R.11,Baron Mira12ORCID,De La Cruz Luis13,Gay Cynthia14,Kalams Spyros15,Kelley Colleen F.16ORCID,Andrasik Michele P.1ORCID,Kublin James G.1ORCID,Corey Lawrence117ORCID,Neuzil Kathleen M.18ORCID,Carpp Lindsay N.1ORCID,Pajon Rolando7,Follmann Dean19ORCID,Donis Ruben O.8ORCID,Koup Richard A.5ORCID, , , ,

Affiliation:

1. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

2. Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

3. Department of Biostatistics, University of Washington, Seattle, WA, USA.

4. Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.

5. Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

6. Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.

7. Moderna, Inc., Cambridge, MA, USA.

8. Biomedical Advanced Research and Development Authority, Washington, DC, USA.

9. Division of Biostatistics, School of Public Health, University of California Berkeley, Berkeley, CA, USA.

10. Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.

11. Brigham and Women’s Hospital, Boston, MA, USA.

12. Palm Beach Research Center, West Palm Beach, FL, USA.

13. Keystone Vitalink Research, Greenville, SC, USA.

14. Department of Medicine, Division of Infectious Diseases, UNC HIV Cure Center, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.

15. Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

16. Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine and the Grady Health System, Atlanta, GA, USA.

17. Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.

18. Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.

19. Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

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

Publisher

American Association for the Advancement of Science (AAAS)

Subject

Multidisciplinary

Reference53 articles.

1. World Health Organization “Coronavirus Disease (COVID-19): COVID-19 vaccine EUL issued” (2021); https://extranet.who.int/pqweb/vaccines/covid-19-vaccines.

2. US Food and Drug Administration (FDA) “COVID-19 Vaccines: COVID-19 Vaccines Authorized for Emergency Use” (2021); www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines#news [last updated 11 March 2021].

3. US Food and Drug Administration “FDA Approves First COVID-19 Vaccine: Approval Signifies Key Achievement for Public Health” (FDA news release 23 August 2021); www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

4. C. Weller “Four reasons why we need multiple vaccines for Covid-19” (Wellcome Opinion 6 June 2021); https://wellcome.org/news/four-reasons-why-we-need-multiple-vaccines-covid-19.

5. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment

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