2024
The public health impact and cost-effectiveness of the R21/Matrix-M malaria vaccine: a mathematical modelling study
Schmit N, Topazian H, Natama H, Bellamy D, Traoré O, Somé M, Rouamba T, Tahita M, Bonko M, Sourabié A, Sorgho H, Stockdale L, Provstgaard-Morys S, Aboagye J, Woods D, Rapi K, Datoo M, Lopez F, Charles G, McCain K, Ouedraogo J, Hamaluba M, Olotu A, Dicko A, Tinto H, Hill A, Ewer K, Ghani A, Winskill P. The public health impact and cost-effectiveness of the R21/Matrix-M malaria vaccine: a mathematical modelling study. The Lancet Infectious Diseases 2024, 24: 465-475. PMID: 38342107, DOI: 10.1016/s1473-3099(23)00816-2.Peer-Reviewed Original ResearchDisability-adjusted life yearsClinical malariaMalaria vaccineClinical casesVaccine introductionVaccinated childrenVaccine efficacyYears of follow-upPhase 2b trialPhase 3 trialSub-Saharan AfricaSurrogate of protectionIncremental costAntibody titresPublic health impactSerum Institute of IndiaBill &Cost-effectiveness ratioChildren aged 2Dose pricesMalaria deathsMelinda Gates FoundationNIHR Oxford Biomedical Research CentreFollow-upUK Medical Research CouncilSafety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial
Datoo M, Dicko A, Tinto H, Ouédraogo J, Hamaluba M, Olotu A, Beaumont E, Lopez F, Natama H, Weston S, Chemba M, Compaore Y, Issiaka D, Salou D, Some A, Omenda S, Lawrie A, Bejon P, Rao H, Chandramohan D, Roberts R, Bharati S, Stockdale L, Gairola S, Greenwood B, Ewer K, Bradley J, Kulkarni P, Shaligram U, Hill A, Group R, Mahamar A, Sanogo K, Sidibe Y, Diarra K, Samassekou M, Attaher O, Tapily A, Diallo M, Dicko O, Kaya M, Maguiraga S, Sankare Y, Yalcouye H, Diarra S, Niambele S, Thera I, Sagara I, Sylla M, Dolo A, Misidai N, Simando S, Msami H, Juma O, Gutapaka N, Paul R, Mswata S, Sasamalo I, Johaness K, Sultan M, Alexander A, Kimaro I, Lwanga K, Mtungwe M, Khamis K, Rugarabam L, Kalinga W, Mohammed M, Kamange J, Msangi J, Mwaijande B, Mtaka I, Mhapa M, Mlaganile T, Mbaga T, Yerbanga R, Samtouma W, Sienou A, Kabre Z, Ouedraogo W, Yarbanga G, Zongo I, Savadogo H, Sanon J, Compaore J, Kere I, Yoni F, Sanre T, Ouattara S, Provstgaard-Morys S, Woods D, Snow R, Amek N, Ngetsa C, Ochola-Oyier L, Musyoki J, Munene M, Mumba N, Adetifa U, Muiruri C, Mwawaka J, Mwaganyuma M, Ndichu M, Weya J, Njogu K, Grant J, Webster J, Lakhkar A, Ido N, Traore O, Tahita M, Bonko M, Rouamba T, Ouedraogo D, Soma R, Millogo A, Ouedraogo E, Sorgho F, Konate F, Valea I. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. The Lancet 2024, 403: 533-544. PMID: 38310910, DOI: 10.1016/s0140-6736(23)02511-4.Peer-Reviewed Original ResearchConceptsClinical malaria episodesPhase 3 trialMalaria episodesMonths age groupAdverse eventsVaccine efficacyClinical malariaMalaria vaccineDouble-blindMalaria transmissionControl vaccineAsn-Ala-Asn-ProAge groupsStandard sitesMonths of follow-upAfrican childrenPerennial malaria transmissionBurden of malariaSeasonal malaria transmissionMalaria transmission intensityPhase 2b trialInjection site painFrequent adverse eventsCo-primary endpointsVaccine-induced antibodies
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
2020
Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention
Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, Diarra M, Tapily A, Issiaka D, Sanogo K, Mahamar A, Sompougdou F, Yerbanga S, Thera I, Milligan P, Tinto H, Ofori-Anyinam O, Ouedraogo J, Greenwood B. Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01E vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention. BMJ Open 2020, 10: e035433. PMID: 32933955, PMCID: PMC7493088, DOI: 10.1136/bmjopen-2019-035433.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionClinical malariaTransmission seasonMalaria chemopreventionSeasonal vaccinationDoses of RTSWeekly active surveillancePlacebo-controlled trialPhase 3 trialMalaria transmission seasonPositive blood filmPrevalence of malariaSubsequent transmission seasonSubset of childrenCombination of vaccinationBooster doseModified intentionPrimary endpointControl vaccineFirst doseMalaria vaccineActive surveillanceCase detectionRabies vaccineHealth facilities
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