2024
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial
Ogbuagu O, Molina J, Chetchotisakd P, Ramgopal M, Sanchez W, Brunetta J, Castelli F, Crofoot G, Hung C, Ronot-Bregigeon S, Margot N, Wang H, Dvory-Sobol H, Rhee M, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clinical Infectious Diseases 2024, ciae423. PMID: 39206943, DOI: 10.1093/cid/ciae423.Peer-Reviewed Original ResearchMultidrug-resistant HIV-1Optimized background regimenHIV-1 RNA <CD4 cell countHIV-1Food & Drug AdministrationAdverse eventsTreatment of HIV-1 infectionRates of virologic suppressionCD4 cell count <Treatment-related adverse eventsMulti-drug resistant HIV-1Cell countTreatment-experienced peopleCell count <HIV-1 infectionHIV-1 RNAPhase 2/3 trialsImportant treatment optionInjection site reactionsResistant HIV-1US Food & Drug AdministrationBackground regimenVirologic suppressionStudy drug
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