2024
Safety 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 ResearchMeSH KeywordsBurkina FasoChemopreventionChildChild, PreschoolHumansInfantMalariaMalaria VaccinesMalaria, FalciparumMaliSeasonsVaccinationConceptsSeasonal 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 admissionCost of introducing and delivering malaria vaccine (RTS,S/AS01E) in areas of seasonal malaria transmission, Mali and Burkina Faso
Diawara H, Bocoum F, Dicko A, Levin A, Lee C, Koita F, Ouédraogo J, Guissou R, Yabré S, Traoré S, Morgan W, Pecenka C, Baral R. Cost of introducing and delivering malaria vaccine (RTS,S/AS01E) in areas of seasonal malaria transmission, Mali and Burkina Faso. BMJ Global Health 2023, 8: e011316. PMID: 37068848, PMCID: PMC10111920, DOI: 10.1136/bmjgh-2022-011316.Peer-Reviewed Original ResearchConceptsVaccine deliverySeasonal vaccinationMalaria vaccineMalaria transmissionSeasonal malaria transmissionRoutine Expanded ProgrammeResource use dataRoutine EPINew vaccine introductionSeasonal malariaVaccine introductionMain cost driversHealth facilitiesExpanded ProgrammeVaccine priceVaccine rolloutMass campaignsService deliveryYoung childrenVaccinationCost consequencesBurkina FasoFinancial costsVaccineDelivery approach
2022
Seasonal use case for the RTS,S/AS01 malaria vaccine: a mathematical modelling study
Thompson H, Hogan A, Walker P, Winskill P, Zongo I, Sagara I, Tinto H, Ouedraogo J, Dicko A, Chandramohan D, Greenwood B, Cairns M, Ghani A. Seasonal use case for the RTS,S/AS01 malaria vaccine: a mathematical modelling study. The Lancet Global Health 2022, 10: e1782-e1792. PMID: 36400084, DOI: 10.1016/s2214-109x(22)00416-8.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionSeasonal transmission settingsS vaccinationTransmission settingsTransmission seasonFull therapeutic coursePhase 3b trialSevere malaria outcomesUK Medical Research CouncilEstimates of casesDuration of protectionMalaria transmission intensityEntomological inoculation rateGreater absolute reductionMedical Research CouncilTransmission intensitySignificant additional protectionAge-based strategiesMalaria outcomesClinical malariaMalaria chemopreventionVaccination scheduleMalaria vaccineClinical incidenceClinical trialsThe duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone
Cairns M, Barry A, Zongo I, Sagara I, Yerbanga S, Diarra M, Zoungrana C, Issiaka D, Sienou A, Tapily A, Sanogo K, Kaya M, Traore S, Diarra K, Yalcouye H, Sidibe Y, Haro A, Thera I, Snell P, Grant J, Tinto H, Milligan P, Chandramohan D, Greenwood B, Dicko A, Ouedraogo J. The duration of protection against clinical malaria provided by the combination of seasonal RTS,S/AS01E vaccination and seasonal malaria chemoprevention versus either intervention given alone. BMC Medicine 2022, 20: 352. PMID: 36203149, PMCID: PMC9540742, DOI: 10.1186/s12916-022-02536-5.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, ProtozoanChemopreventionHumansInfantMalariaMalaria VaccinesMalaria, FalciparumPlasmodium falciparumSeasonsVaccinationConceptsDuration of protectionSeasonal malaria chemopreventionClinical malariaMalaria chemopreventionProtective efficacyDifferent vaccine delivery systemsFlexible parametric survival modelsMalaria transmission seasonOverall protective efficacyVaccine delivery systemChild clusteringBooster dosesSeasonal vaccinationMalaria vaccinationSevere malariaDelivery intervalParametric survival modelsCox regressionMalaria vaccinePrimary seriesRecent trialsIntervention groupConclusionsThe efficacyAS01ECox modelEvaluation of the Pfs25-IMX313/Matrix-M malaria transmission-blocking candidate vaccine in endemic settings
Mulamba C, Williams C, Kreppel K, Ouedraogo J, Olotu A. Evaluation of the Pfs25-IMX313/Matrix-M malaria transmission-blocking candidate vaccine in endemic settings. Malaria Journal 2022, 21: 159. PMID: 35655174, PMCID: PMC9161629, DOI: 10.1186/s12936-022-04173-y.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsHumansInsecticide ResistanceMalaria VaccinesMosquito VectorsNanoparticlesSaponinsConceptsEndemic settingsMalaria transmission-blocking vaccineHuman vaccine trialsTransmission-blocking vaccinesPublic health importanceMosquito vectorsMiddle-income settingsAnti-malarial drugsImmunological mechanismsCandidate vaccinesVaccine trialsHealthy individualsIncome settingsTransmission blockingHealth importanceMalaria controlMalaria parasitesVaccineLocal interventionsDrugsInterventionSettingSexual stagesPfs25Disease
2021
The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine
Sagara I, Zongo I, Cairns M, Yerbanga R, Mahamar A, Nikièma F, Tapily A, Sompougdou F, Diarra M, Zoungrana C, Issiaka D, Haro A, Sanogo K, Sienou A, Kaya M, Traore S, Thera I, Diarra K, Dolo A, Kuepfer I, Snell P, Milligan P, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Ouedraogo J, Dicko A, Chandramohan D, Greenwood B. The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine. Clinical Infectious Diseases 2021, 75: 613-622. PMID: 34894221, PMCID: PMC9464075, DOI: 10.1093/cid/ciab1017.Peer-Reviewed Original ResearchMeSH KeywordsAntibody FormationChildHumansInfantMalariaMalaria VaccinesMalaria, FalciparumPlasmodium falciparumSeasonsVaccinationConceptsFirst booster doseDoses of RTSBooster doseAntibody responseSeasonal vaccinationPost-vaccination antibody titersAnti-circumsporozoite antibodiesBooster antibody responseDiminished antibody responsePrimary vaccination seriesSeasonal malaria chemopreventionSecond booster doseStrong antibody responseIncidence of malariaSubset of childrenEnzyme-linked immunosorbentVaccination seriesBooster dosesMalaria chemopreventionSevere malariaMalaria vaccineAntibody titersLower incidenceVaccinationAS01ECombining malaria vaccination with chemoprevention: a promising new approach to malaria control
Greenwood B, Cairns M, Chaponda M, Chico R, Dicko A, Ouedraogo J, Phiri K, ter Kuile F, Chandramohan D. Combining malaria vaccination with chemoprevention: a promising new approach to malaria control. Malaria Journal 2021, 20: 361. PMID: 34488784, PMCID: PMC8419817, DOI: 10.1186/s12936-021-03888-8.Peer-Reviewed Original ResearchConceptsIntermittent preventive treatmentMalaria controlMalaria chemopreventionMalaria vaccinationMalaria vaccinePreventive treatmentPost-discharge malaria chemopreventionSeasonal malaria chemopreventionManagement of childrenPrevention of malariaMass drug administrationSickle cell diseaseMalaria elimination programmeClinical malariaSevere malariaSevere anemiaMalaria deathsRecent trialsCell diseaseChemopreventive regimenDrug AdministrationClinical situationsVaccinationElimination programChemopreventionSeasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention
Chandramohan D, Zongo I, Sagara I, Cairns M, Yerbanga R, Diarra M, Nikièma F, Tapily A, Sompougdou F, Issiaka D, Zoungrana C, Sanogo K, Haro A, Kaya M, Sienou A, Traore S, Mahamar A, Thera I, Diarra K, Dolo A, Kuepfer I, Snell P, Milligan P, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Ouédraogo J, Dicko A, Greenwood B. Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention. New England Journal Of Medicine 2021, 385: 1005-1017. PMID: 34432975, DOI: 10.1056/nejmoa2026330.Peer-Reviewed Original ResearchConceptsUncomplicated malariaProtective efficacyClinical malariaSevere malariaMalaria-related outcomesSeasonal malaria chemopreventionUncomplicated clinical malariaVaccine-alone groupWorld Health Organization definitionPrespecified noninferiority marginMonths of ageMalaria chemopreventionSeasonal vaccinationFirst doseHazard ratioMalaria vaccinationFebrile seizuresHospital admissionCombination groupNoninferiority marginLower incidenceAS01ChemopreventionChildren 5Organization definition
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
2017
Seasonal vaccination against malaria: a potential use for an imperfect malaria vaccine
Greenwood B, Dicko A, Sagara I, Zongo I, Tinto H, Cairns M, Kuepfer I, Milligan P, Ouedraogo J, Doumbo O, Chandramohan D. Seasonal vaccination against malaria: a potential use for an imperfect malaria vaccine. Malaria Journal 2017, 16: 182. PMID: 28464937, PMCID: PMC5414195, DOI: 10.1186/s12936-017-1841-9.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionMalaria vaccineTransmission seasonEffective malaria control measuresEffective immunological memoryMalaria transmission seasonHigh transmission seasonMass vaccination campaignMalaria control measuresHigh initial efficacyMalaria chemopreventionSeasonal vaccinationSulfadoxine-pyrimethamineMalaria infectionMalaria treatmentImmunological memoryPilot implementation projectVaccination campaignInitial efficacyFull courseMalaria transmissionVaccineEuropean Medicines AuthorityHealthcare giversMajor cause
2013
Anti-Pfs25 Human Plasma Reduces Transmission of Plasmodium falciparum Isolates That Have Diverse Genetic Backgrounds
Da D, Dixit S, Sattabonkot J, Mu J, Abate L, Ramineni B, Ouedraogo J, MacDonald N, Fay M, Su X, Cohuet A, Wu Y. Anti-Pfs25 Human Plasma Reduces Transmission of Plasmodium falciparum Isolates That Have Diverse Genetic Backgrounds. Infection And Immunity 2013, 81: 1984-1989. PMID: 23509152, PMCID: PMC3676035, DOI: 10.1128/iai.00016-13.Peer-Reviewed Original ResearchConceptsPhase 1 trialParasite isolatesMalaria transmission-blocking vaccineTransmission-reducing activityTransmission-blocking activityPlasmodium falciparum isolatesTransmission-blocking vaccinesPlasmodium falciparum parasitesLimited sequence polymorphismPfs25 antibodiesMontanide ISA51Immune plasmaNonimmune controlsRecombinant Pfs25Falciparum isolatesPfs25 geneFalciparum parasitesGenetic backgroundPatientsBurkina FasoPfs25VaccineTrialsNucleotide polymorphismsIsolates
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