biostudies-literaturede Bruyn GBiomedical Advanced Research and Development AuthorityNIAID NIH HHSSanofi102109https://www.ebi.ac.uk/biostudies/studies/S-EPMC10391925biostudies-literatureUnknown62<h4>Background</h4>In a parallel-group, international, phase 3 study (ClinicalTrials.govNCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03).<h4>Methods</h4>Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18-55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control EClinicalMedicineSafety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study.PMC10391925U01 AI069470UM1 AI069470Sagot LBueso ASavarino SPurvis YFEssink BAdhikarla HRuiz MSMenard LTreanor JDellanno COgbuagu OChin THe CHomlqvist CKimmel MDel Campo Perez VHudzina KTuret NBrune DFinn AHebert CKasztejna JRivera-Medina DMMohammed ACoux FSobieszczyk MGarrido JSeverance RBirch TGonzalez CRoberson RConrad AGurunathan SOrtiz JLefebvre MWhittington AKeefer MToma RWhite JLaine FBreuer TBreymeier CGirodet POLopez DHaney ORuiz Antoraz MBLoryne LHenderson JARaabe VRoy BForrat REmmett SPerroud APTong TFu BGrosbois MAPeyton GNicolas JFCeregido MATourneux SGelu-Maury SMichael NLShi Jde Bruyn GVAT00002 booster cohorts study teamSridhar SDavis YCosta-Araujo CMendoza SWang JSchuerman LRouphael NCanter RMKandasamy RSher LDMaakaroun-Vermesse ZPerez Breva LKaminski RMasotti RHammond JGriffin PHolmqvist CLourdes MPPark JJennifer BKoutsoukos MBen-Ghezala ILaunay OHutchens MFroget RRojo Conejo PGallais JFribbens CPurvis AZacher JPhillipson ABonaparte MIJackson Booth PGGrillet MHTavares-Da-Silva FRomanyak NChicz RMRivas EThuy TPMalishchak CTorres FMSchwartz HJoaquin AKresge MSater NDussol BMulamalla MRook CWalsh SAlvi SMulholland PMoore PValerie BStevens CDeshmukh SDiemert DfalseSafety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study.<h4>Background</h4>In a parallel-group, international, phase 3 study (ClinicalTrials.govNCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03).<h4>Methods</h4>Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18-55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control 2023-01-01T00:00:00Z2023 Aug2026-05-28T08:38:18.589Z2024-11-19T22:40:56.838ZS-EPMC103919253753341910.1016/j.eclinm.2023.102109