{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["de Bruyn G"],"funding":["Biomedical Advanced Research and Development Authority","NIAID NIH HHS","Sanofi"],"pagination":["102109"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10391925"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["62"],"pubmed_abstract":["<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 "],"journal":["EClinicalMedicine"],"pubmed_title":["Safety 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."],"pmcid":["PMC10391925"],"funding_grant_id":["U01 AI069470","UM1 AI069470"],"pubmed_authors":["Sagot L","Bueso A","Savarino S","Purvis YF","Essink B","Adhikarla H","Ruiz MS","Menard L","Treanor J","Dellanno C","Ogbuagu O","Chin T","He C","Homlqvist C","Kimmel M","Del Campo Perez V","Hudzina K","Turet N","Brune D","Finn A","Hebert C","Kasztejna J","Rivera-Medina DM","Mohammed A","Coux F","Sobieszczyk M","Garrido J","Severance R","Birch T","Gonzalez C","Roberson R","Conrad A","Gurunathan S","Ortiz J","Lefebvre M","Whittington A","Keefer M","Toma R","White J","Laine F","Breuer T","Breymeier C","Girodet PO","Lopez D","Haney O","Ruiz Antoraz MB","Loryne L","Henderson JA","Raabe V","Roy B","Forrat R","Emmett S","Perroud AP","Tong T","Fu B","Grosbois MA","Peyton G","Nicolas JF","Ceregido MA","Tourneux S","Gelu-Maury S","Michael NL","Shi J","de Bruyn G","VAT00002 booster cohorts study team","Sridhar S","Davis Y","Costa-Araujo C","Mendoza S","Wang J","Schuerman L","Rouphael N","Canter RM","Kandasamy R","Sher LD","Maakaroun-Vermesse Z","Perez Breva L","Kaminski R","Masotti R","Hammond J","Griffin P","Holmqvist C","Lourdes MP","Park J","Jennifer B","Koutsoukos M","Ben-Ghezala I","Launay O","Hutchens M","Froget R","Rojo Conejo P","Gallais J","Fribbens C","Purvis A","Zacher J","Phillipson A","Bonaparte MI","Jackson Booth PG","Grillet MH","Tavares-Da-Silva F","Romanyak N","Chicz RM","Rivas E","Thuy TP","Malishchak C","Torres FM","Schwartz H","Joaquin A","Kresge M","Sater N","Dussol B","Mulamalla M","Rook C","Walsh S","Alvi S","Mulholland P","Moore P","Valerie B","Stevens C","Deshmukh S","Diemert D"],"additional_accession":[]},"is_claimable":false,"name":"Safety 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.","description":"<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 ","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Aug","modification":"2026-05-28T08:38:18.589Z","creation":"2024-11-19T22:40:56.838Z"},"accession":"S-EPMC10391925","cross_references":{"pubmed":["37533419"],"doi":["10.1016/j.eclinm.2023.102109"]}}