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
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial
Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD, team D, Antinori A, Apea V, Asmuth D, Avery A, Benson P, Bergin C, Berhe M, Brar I, Brinson C, Brunetta J, Burack J, Campbell T, Cespedes M, Clarke A, Coleman M, Coll J, Casal M, Creticos C, Crofoot G, Cruickshank F, Cua E, Daar E, de Wet J, DeJesus E, Del Romero Guerrero J, Dinges W, Doblecki-Lewis S, Donovan T, Dosekun O, Flamm J, Gallant J, Gerstoft J, Gilson R, Gladstein J, Grant R, Grossberg R, Haas B, Halperin J, Hardy W, Hare C, Hassler S, Hengel R, Henry W, Hodge T, Hosek S, Hurt C, Iandiorio M, Jessen H, Kegg S, Knecht G, Kronborg G, Krznaric I, LaMarca A, Larsen C, Larsen O, Lazzarin A, Leen C, Lucasti C, Mallon P, Mannheimer S, Markowitz M, Martorell C, Mayer K, Mills A, Molina J, Morris S, Mounzer K, Nwokolo N, Ogbuagu O, Osiyemi O, Petroll A, Philibert P, Phoenix J, Pialoux G, Podzamczer D, Post F, Prins M, Ramgopal M, Rashbaum B, Reeves I, Richmond G, Rieger A, Ruane P, Salazar L, Scarsella A, Schembri G, Scott M, Shalit P, Sinclair G, Sobieszczyk M, Spinner C, Stephens J, Szabo J, Taylor S, Thompson M, Tremblay C, Trottier B, Voskuhl G, Wade B, Wohl D, Workowski K, Yawetz S, Young B. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet HIV 2021, 8: e397-e407. PMID: 34197772, DOI: 10.1016/s2352-3018(21)00071-0.Peer-Reviewed Original ResearchConceptsTenofovir disoproxil fumaratePre-exposure prophylaxisTenofovir alafenamideDisoproxil fumarateBone mineral densityHIV infectionPlacebo tabletsMineral densityHIV preventionHIV-1 pre-exposure prophylaxisTransgender womenAdult cisgender menNon-inferior efficacyWeek 96 resultsPrimary efficacy outcomeCisgender menPhase 3 trialIncident HIV infectionHIV-1 infectionNon-inferiority trialLong-term safetyMore weight gainRenal safety biomarkersSelf-reported sexual behaviorStudy medication