Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine

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

Medienart:	Preprint

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	bioRxiv.org - (2024) vom: 30. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Beteiligte Personen:

Launay, Odile [VerfasserIn] Cachanado, Marine [VerfasserIn] Nguyen, Liem B Luong [VerfasserIn] Ninove, Laetitia [VerfasserIn] Lachâtre, Marie [VerfasserIn] Ben Ghezala, Inès [VerfasserIn] Bardou, Marc [VerfasserIn] Schmidt-Mutter, Catherine [VerfasserIn] Felten, Renaud [VerfasserIn] Lacombe, Karine [VerfasserIn] Surgers, Laure [VerfasserIn] Laine, Fabrice [VerfasserIn] Allain, Jean-Sébastien [VerfasserIn] Botelho-Nevers, Elisabeth [VerfasserIn] Tavolacci, Marie-Pierre [VerfasserIn] Chidiac, Christian [VerfasserIn] Pavese, Patricia [VerfasserIn] Dussol, Bertrand [VerfasserIn] Priet, Stéphane [VerfasserIn] Deplanque, Dominique [VerfasserIn] Touati, Amel [VerfasserIn] Curci, Laureen [VerfasserIn] Konate, Eleine [VerfasserIn] Hamouda, Nadine Ben [VerfasserIn] Besbes, Anissa [VerfasserIn] Nubret, Eunice [VerfasserIn] Capelle, Florence [VerfasserIn] Berard, Laurence [VerfasserIn] Rousseau, Alexandra [VerfasserIn] Tartour, Eric [VerfasserIn] Simon, Tabassome [VerfasserIn] de Lamballerie, Xavier [VerfasserIn]

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Themen:	570 Biology

doi:	10.1101/2022.05.25.22274904

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PPN (Katalog-ID):	XBI036125024