Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study.
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SUBMITTER: Sridhar S
PROVIDER: S-EPMC8789245 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
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Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study.
Sridhar Saranya S Joaquin Arnel A Bonaparte Matthew I MI Bueso Agustin A Chabanon Anne-Laure AL Chen Aiying A Chicz Roman M RM Diemert David D Essink Brandon J BJ Fu Bo B Grunenberg Nicole A NA Janosczyk Helene H Keefer Michael C MC Rivera M Doris M DM Meng Ya Y Michael Nelson L NL Munsiff Sonal S SS Ogbuagu Onyema O Raabe Vanessa N VN Severance Randall R Rivas Enrique E Romanyak Natalya N Rouphael Nadine G NG Schuerman Lode L Sher Lawrence D LD Walsh Stephen R SR White Judith J von Barbier Dalia D de Bruyn Guy G Canter Richard R Grillet Marie-Helene MH Keshtkar-Jahromi Maryam M Koutsoukos Marguerite M Lopez Denise D Masotti Roger R Mendoza Sandra S Moreau Catherine C Ceregido Maria Angeles MA Ramirez Shelly S Said Ansoyta A Tavares-Da-Silva Fernanda F Shi Jiayuan J Tong Tina T Treanor John J Diazgranados Carlos A CA Savarino Stephen S
The Lancet. Infectious diseases 20220125 5
<h4>Background</h4>We evaluated our SARS-CoV-2 prefusion spike recombinant protein vaccine (CoV2 preS dTM) with different adjuvants, unadjuvanted, and in a one-injection and two-injection dosing schedule in a previous phase 1-2 study. Based on interim results from that study, we selected a two-injection schedule and the AS03 adjuvant for further clinical development. However, lower than expected antibody responses, particularly in older adults, and higher than expected reactogenicity after the s ...[more]
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