Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial

Author:

Branche Angela1,Rouphael Nadine2,Diemert David3ORCID,Falsey Ann1,Losada Cecilia4,Baden Lindsey (R)5,Frey Sharon6,Whitaker Jennifer7,Little Susan8ORCID,Anderson Evan9ORCID,Walter Emmanuel10,Novak Richard11,Rupp Richard12,Jackson Lisa13,Babu Tara14,Kottkamp Angelica15ORCID,Luetkemeyer Annie16,Immergluck Lilly17,Presti Rachel18ORCID,Backer Martin19,Winokur Patricia20,Mahgoub Siham21,Goepfert Paul22,Fusco DahleneORCID,Malkin Elissa3ORCID,Bethony Jeff3,Walsh Edward1,Graciaa Daniel23ORCID,Samaha Hady24ORCID,Sherman Amy25ORCID,Walsh Stephen26ORCID,Abate Getahun6,Oikonomopoulou Zacharoula6,Sahly Hana El7,Martin Thomas27,Kamidani Satoshi28ORCID,Smith Michael29,Ladner Benjamin11,Porterfield Laura12ORCID,Dunstan Maya30,Wald Anna14,Davis Tamia15,Atmar Robert7ORCID,Mulligan Mark31,Lyke Kirsten32ORCID,Posavad Christine33,Meagher Megan34ORCID,Stephens David35ORCID,Neuzil Kathleen36ORCID,Abebe Kuleni37,Hill Heather38,Albert Jim39,Telu Kalyani38,Mu Jinjian38,Lewis Teri40,Giebeig Lisa40,Eaton Amanda41ORCID,Netzl Antonia42,Wilks Sam43,Tureli Sina42,Makhene Mamodikoe44,Crandon Sonja45,Montefiori David46,Makowski Mat38,Smith Derek42,Nayak Seema45,Roberts Paul44,Beigel John47ORCID

Affiliation:

1. University of Rochester

2. Emory Unviversity

3. George Washington University

4. Emory University Hope Clinic

5. Brigham & Women’s Hospital and Harvard Medical School

6. Saint Louis University

7. Baylor College of Medicine

8. Department of Medicine, University of California, San Diego, CA 92903

9. evanderson@emory.edu

10. Duke University School of Medicine

11. University of Illinois at Chicago

12. University of Texas Medical Branch

13. Kaiser Permanente Washington Health Research Institute

14. University of Washington

15. NYU Langone Manhattan

16. Zuckerberg San Francisco General Hospital UCSF

17. Morrehouse School of Medicine

18. Washington University School of Medicine

19. NYU Langone Long Island

20. University of Iowa

21. Howard University Hospital

22. Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham

23. Department of Medicine, Emory University School of Medicine

24. Emory University School of Medicine

25. Brigham and Women's Hospital

26. Harvard University

27. University of California San Diego

28. Center for Childhood Infections and Vaccines (CCIV) of Children's Healthcare of Atlanta and Emory University Department of Pediatrics

29. Duke University

30. Kaiser Permanente Washington Health

31. NYU Langone Medical Center

32. Center for Vaccine Development and Global Health, University of Maryland School of Medicine

33. Department of Laboratory Medicine and Pathology, University of Washington

34. Fred Hutchinson Cancer Center

35. Emory University

36. University of Maryland School of Medicine

37. NIH

38. The Emmes Company

39. The Emmes Company, LLC

40. 29. Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research

41. Duke University Medical Center

42. University of Cambridge

43. Centre for Pathogen Evolution, Department of Zoology, University of Cambridge

44. Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

45. Division of Microbiology and Infectious Diseases, NIAID, NIH

46. Duke

47. Leidos Biomedical Research Inc.

Abstract

Abstract Vaccine protection against COVID-19 wanes over time and has been impacted by the emergence of new variants with increasing escape of neutralization. The COVID-19 Variant Immunologic Landscape (COVAIL) randomized clinical trial (clinicaltrials.gov NCT 05289037) compares the breadth, magnitude and durability of antibody responses induced by a second COVID-19 vaccine boost with mRNA (Moderna mRNA-1273 and Pfizer-BioNTech BNT162b2), or adjuvanted recombinant protein (Sanofi CoV2 preS DTM-AS03) monovalent or bivalent vaccine candidates targeting ancestral and variant SARS-CoV-2 spike antigens (Beta, Delta and Omicron BA.1). We found that boosting with a variant strain is not associated with loss in neutralization against the ancestral strain. However, while variant vaccines compared to the prototype/wildtype vaccines demonstrated higher neutralizing activity against Omicron BA.1 and BA.4/5 subvariants for up to 3 months after vaccination, neutralizing activity was lower for more recent Omicron subvariants. Our study, incorporating both antigenic distances and serologic landscapes, can provide a framework for objectively guiding decisions for future vaccine updates.

Publisher

Research Square Platform LLC

Reference46 articles.

1. WHO. World Health Organization, Weekly Operational Update on COVID-19. https://wwwwhoint/emergencies/diseases/novel-coronavirus-2019/situation-reports 2020a;Accessed January 20, 2022..

2. JHU. COVID-19 Dashboard, Center for Systems Science and Engineering (CCSE) at Johns Hopkins University (JHU). https://coronavirus.jhu.edu/map.html.;Accessed January 20, 2022.

3. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine;Baden LR;N Engl J Med.,2021

4. Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses;Bos R;NPJ Vaccines.,2020

5. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine;Polack FP;N Engl J Med.,2020

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