2022
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 S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. 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. The Lancet Infectious Diseases 2022, 22: 636-648. PMID: 35090638, PMCID: PMC8789245, DOI: 10.1016/s1473-3099(21)00764-7.Peer-Reviewed Original ResearchConceptsHigh-dose groupLow-dose groupMedium-dose groupGeometric mean titresAdverse eventsRecombinant protein vaccineCOVID-19 vaccineSecond vaccinationSARS-CoV-2Day 36Antigen doseAdverse reactionsProtein vaccineMedical conditionsVaccine-related serious adverse eventsHigh-risk medical conditionsInteractive response technology systemAntibody geometric mean titresPre-existing medical conditionsCandidate vaccine formulationsCoV2 preS dTMPrevious phase 1Primary immunogenicity objectivePseudovirus neutralization assayUnsolicited adverse events
2021
Qualitative assessment of anti‐SARS‐CoV‐2 spike protein immunogenicity (QUASI) after COVID‐19 vaccination in older people living with HIV
Tuan JJ, Zapata H, Critch‐Gilfillan T, Ryall L, Turcotte B, Mutic S, Andrews L, Roh ME, Friedland G, Barakat L, Ogbuagu O. Qualitative assessment of anti‐SARS‐CoV‐2 spike protein immunogenicity (QUASI) after COVID‐19 vaccination in older people living with HIV. HIV Medicine 2021, 23: 178-185. PMID: 34632695, PMCID: PMC8652674, DOI: 10.1111/hiv.13188.Peer-Reviewed Original ResearchMeSH KeywordsAgedBNT162 VaccineHIV InfectionsHumansImmunogenicity, VaccineQualitative ResearchSpike Glycoprotein, CoronavirusConceptsCOVID-19 vaccineCOVID-19 vaccinationFirst doseSeroconversion ratesSecond doseAcute respiratory syndrome coronavirus 2 infectionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionYale New Haven Health SystemPrior COVID-19 infectionSyndrome coronavirus 2 infectionSafe COVID-19 vaccineIntegrase strand transfer inhibitorsAnti-spike IgGPositive IgG responseTwo-dose seriesCoronavirus 2 infectionVaccine-induced immunityDurability of protectionCOVID-19 infectionStrand transfer inhibitorsAntiretroviral regimenBNT162b2 vaccineNew seroconversionsPositive IgGQualitative antibody