2023
Seasonal vaccination with RTS,S/AS01E vaccine with or without seasonal malaria chemoprevention in children up to the age of 5 years in Burkina Faso and Mali: a double-blind, randomised, controlled, phase 3 trial
Dicko A, Ouedraogo J, Zongo I, Sagara I, Cairns M, Yerbanga R, Issiaka D, Zoungrana C, Sidibe Y, Tapily A, Nikièma F, Sompougdou F, Sanogo K, Kaya M, Yalcouye H, Dicko O, Diarra M, Diarra K, Thera I, Haro A, Sienou A, Traore S, Mahamar A, Dolo A, Kuepfer I, Snell P, Grant J, Webster J, Milligan P, Lee C, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Chandramohan D, Greenwood B. Seasonal vaccination with RTS,S/AS01E vaccine with or without seasonal malaria chemoprevention in children up to the age of 5 years in Burkina Faso and Mali: a double-blind, randomised, controlled, phase 3 trial. The Lancet Infectious Diseases 2023, 24: 75-86. PMID: 37625434, DOI: 10.1016/s1473-3099(23)00368-7.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionPhase 3 trialClinical malariaAlone groupMalaria Vaccine InitiativeMalaria chemopreventionSeasonal vaccinationProtective efficacyCombined groupPATH Malaria Vaccine InitiativeGlobal Health TrialsPrimary trial endpointSeasonal malaria transmissionSingle intervention groupSupplementary Materials sectionBougouni DistrictCause deathModified intentionProtocol populationControl vaccineMalaria vaccinationMalarial anemiaSevere malariaBlood transfusionHospital admission
2012
A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants
Agnandji S, Lell B, Fernandes J, Abossolo B, Methogo B, Kabwende A, Adegnika A, Mordmüller B, Issifou S, Kremsner P, Sacarlal J, Aide P, Lanaspa M, Aponte J, Machevo S, Acacio S, Bulo H, Sigauque B, Macete E, Alonso P, Abdulla S, Salim N, Minja R, Mpina M, Ahmed S, Ali A, Mtoro A, Hamad A, Mutani P, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Bihoun B, Guiraud I, Kaboré B, Sombié O, Guiguemdé R, Ouédraogo J, Hamel M, Kariuki S, Oneko M, Odero C, Otieno K, Awino N, McMorrow M, Muturi-Kioi V, Laserson K, Slutsker L, Otieno W, Otieno L, Otsyula N, Gondi S, Otieno A, Owira V, Oguk E, Odongo G, Woods J, Ogutu B, Njuguna P, Chilengi R, Akoo P, Kerubo C, Maingi C, Lang T, Olotu A, Bejon P, Marsh K, Mwambingu G, Owusu-Agyei S, Asante K, Osei-Kwakye K, Boahen O, Dosoo D, Asante I, Adjei G, Kwara E, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Mahende C, Liheluka E, Malle L, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng H, Rettig T, Bawa J, Sylverken J, Sambian D, Sarfo A, Agyekum A, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Tembo T, Tegha G, Tsidya M, Kilembe J, Chawinga C, Ballou W, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Olivier A, Vekemans J, Carter T, Kaslow D, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P. A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants. New England Journal Of Medicine 2012, 367: 2284-2295. PMID: 23136909, PMCID: PMC10915853, DOI: 10.1056/nejmoa1208394.Peer-Reviewed Original ResearchConceptsPhase 3 trialVaccine efficacySevere malariaWeeks of ageProtocol populationTreat populationClinical malariaCandidate malaria vaccine RTSOngoing phase 3 trialsAnti-circumsporozoite antibodiesMalaria vaccine RTSCoprimary end pointsSerious adverse eventsGeometric mean titersMonths of ageComparator vaccineAdverse eventsFirst doseFirst vaccinationMalaria episodesThird doseMean titersCox regressionMalaria vaccineAfrican infants
2011
First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
Agnandji S, Lell B, Soulanoudjingar S, Fernandes J, Abossolo B, Conzelmann C, Methogo B, Doucka Y, Flamen A, Mordmüller B, Issifou S, Kremsner P, Sacarlal J, Aide P, Lanaspa M, Aponte J, Nhamuave A, Quelhas D, Bassat Q, Mandjate S, Macete E, Alonso P, Abdulla S, Salim N, Juma O, Shomari M, Shubis K, Machera F, Hamad A, Minja R, Mtoro A, Sykes A, Ahmed S, Urassa A, Ali A, Mwangoka G, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Tahita M, Kaboré W, Ouédraogo S, Sandrine Y, Guiguemdé R, Ouédraogo J, Hamel M, Kariuki S, Odero C, Oneko M, Otieno K, Awino N, Omoto J, Williamson J, Muturi-Kioi V, Laserson K, Slutsker L, Otieno W, Otieno L, Nekoye O, Gondi S, Otieno A, Ogutu B, Wasuna R, Owira V, Jones D, Onyango A, Njuguna P, Chilengi R, Akoo P, Kerubo C, Gitaka J, Maingi C, Lang T, Olotu A, Tsofa B, Bejon P, Peshu N, Marsh K, Owusu-Agyei S, Asante K, Osei-Kwakye K, Boahen O, Ayamba S, Kayan K, Owusu-Ofori R, Dosoo D, Asante I, Adjei G, Adjei G, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Kilavo H, Mahende C, Liheluka E, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng H, Rettig T, Bawa J, Sylverken J, Sambian D, Agyekum A, Owusu L, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Msika A, Jumbe A, Chome N, Nyakuipa D, Chintedza J, Ballou W, Bruls M, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Vekemans J, Carter T, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P. First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children. New England Journal Of Medicine 2011, 365: 1863-1875. PMID: 22007715, DOI: 10.1056/nejmoa1102287.Peer-Reviewed Original ResearchConceptsSevere malariaVaccine efficacyProtocol populationMonths of ageOlder age categoriesTreat populationClinical malariaAge categoriesCandidate malaria vaccine RTSOngoing phase 3 studiesAfrican childrenMalaria vaccine RTSPrimary end pointSerious adverse eventsPhase 3 studyPhase 3 trialDoses of vaccineWeeks of ageComparator vaccineAdverse eventsFirst doseConvulsive seizuresMalaria vaccineFirst episodeStudy group