Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine

  1. Odile Launay
  2. Marine Cachanado
  3. Liem B Luong Nguyen
  4. Laetitia Ninove
  5. Marie Lachâtre
  6. Inès Ben Ghezala
  7. Marc Bardou
  8. Catherine Schmidt-Mutter
  9. Renaud Felten
  10. Karine Lacombe
  11. Laure Surgers
  12. Fabrice Laine
  13. Jean-Sébastien Allain
  14. Elisabeth Botelho-Nevers
  15. Marie-Pierre Tavolacci
  16. Christian Chidiac
  17. Patricia Pavese
  18. Bertrand Dussol
  19. Stéphane Priet
  20. Dominique Deplanque
  21. Amel Touati
  22. Laureen Curci
  23. Eleine Konate
  24. Nadine Ben Hamouda
  25. Anissa Besbes
  26. Eunice Nubret
  27. Florence Capelle
  28. Laurence Berard
  29. Alexandra Rousseau
  30. Eric Tartour
  31. Tabassome Simon
  32. Xavier de Lamballerie
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Abstract

Background

Variant-adaptated vaccines against coronavirus disease 2019 (COVID-19) as boosters are needed to increase a broader protection against SARS CoV-2 variants. New adjuvanted recombinant protein vaccines as heterologous boosters could maximize the response.

Methods

In this randomized, single-blinded, multicenter trial, adults who had received two doses of Pfizer-BioNTech mRNA vaccine (BNT162b2) 3 to7 months before were randomly assigned to receive a boost of BNT162b2, Sanofi/GSK SARS-CoV-2 adjuvanted recombinant protein MV D614 (monovalent parental formulation) or SARS-CoV-2 adjuvanted recombinant protein MV B.1.351 vaccine (monovalent Beta formulation). The primary endpoint was the percentage of subjects with a ≥10-fold increase in neutralizing antibody titers for the Wuhan (D614) and B.1.351 (Beta) SARS-CoV-2 viral strains between day 0 and day 15.

Findings

The percentages of participants whose neutralizing antibody titers against the Wuhan (D614) SARS-CoV-2 strain increased by a factor ≥10 between day 0 and day 15 was 55.3% (95% CI 43.4-66.7) in MV D614 group (n=76), 76.1% (64.5-85.4) in MV B.1.351 (Beta) group (n=71) and 63.2% (51.3-73.9) in BNT162b2 group (n=76). These percentages were 44.7% (33.3-56.6), 84.5% (74.0-92.0) and 51.3% (39.6-63.0) for the B.1.351 (Beta) viral strain, respectively. Higher neutralizing antibodies rates against Delta and Omicron BA.1 variants were also elicited after Sanofi/GSK MV Beta vaccine compared to the other vaccines. Comparable reactogenicity profile was observed with the three vaccines.

Interpretation

Heterologous boosting with the Sanofi/GSK Beta formulation vaccine resulted in a higher neutralizing antibody response against Beta variant but also the original strain and Delta and Omicron BA.1 variants, compared with mRNA BNT162b2 vaccine or the Sanofi/GSK MVD614 formulation. New vaccines containing Beta spike protein may represent an interesting strategy for broader protection against SARS CoV-2 variants.

Funding

French Ministries of Solidarity and Health and Research and Sanofi

Trial registration number

<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> identifier <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT05124171">NCT05124171</ext-link> ; EudraCT identifier 2021-004550-33.

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