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
2022
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
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 ResearchConceptsDuration 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 modelImpact of seasonal RTS,S/AS01E vaccination plus seasonal malaria chemoprevention on the nutritional status of children in Burkina Faso and Mali
Grant J, Sagara I, Zongo I, Cairns M, Yerbanga R, Diarra M, Zoungrana C, Issiaka D, Nikièma F, Sompougdou F, Tapily A, Kaya M, Haro A, Sanogo K, Sienou A, Traore S, Thera I, Yalcouye H, Kuepfer I, Snell P, Milligan P, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Chandramohan D, Greenwood B, Dicko A, Ouédraogo J. Impact of seasonal RTS,S/AS01E vaccination plus seasonal malaria chemoprevention on the nutritional status of children in Burkina Faso and Mali. Malaria Journal 2022, 21: 59. PMID: 35193608, PMCID: PMC8864823, DOI: 10.1186/s12936-022-04077-x.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionMalaria chemopreventionSevere wastingHigh burdenTransmission seasonCombined groupNutritional statusMalaria transmission seasonNutritional status indicatorsPrevalence of stuntingIncidence of malariaCross-sectional surveyMalaria vaccinationSevere malariaRecent trialsStudy populationAS01ELow prevalenceAnthropometric measurementsChronic malnutritionTreatment groupsChance findingStudy childrenResultsIn 2017Prevalence
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 ResearchConceptsFirst 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 incidenceVaccinationAS01EEffectiveness of seasonal malaria chemoprevention (SMC) treatments when SMC is implemented at scale: Case–control studies in 5 countries
Cairns M, Ceesay S, Sagara I, Zongo I, Kessely H, Gamougam K, Diallo A, Ogboi J, Moroso D, Van Hulle S, Eloike T, Snell P, Scott S, Merle C, Bojang K, Ouedraogo J, Dicko A, Ndiaye J, Milligan P. Effectiveness of seasonal malaria chemoprevention (SMC) treatments when SMC is implemented at scale: Case–control studies in 5 countries. PLOS Medicine 2021, 18: e1003727. PMID: 34495978, PMCID: PMC8457484, DOI: 10.1371/journal.pmed.1003727.Peer-Reviewed Original ResearchMeSH KeywordsAfrica, WesternAge FactorsAmodiaquineAntimalarialsCase-Control StudiesChild, PreschoolCommunicable Disease ControlDrug CombinationsFemaleHumansIncidenceInfantMalaria, FalciparumMaleParasite LoadPlasmodium falciparumProgram EvaluationPyrimethamineRisk AssessmentRisk FactorsSeasonsSulfadoxineTime FactorsTreatment OutcomeConceptsSeasonal malaria chemopreventionCase-control studyClinical malariaOdds ratioClinical trialsNational Malaria Control ProgrammeClinical malaria incidenceIndividual case-control studiesIncidence rate ratiosHigh protective efficacyConditional logistic regressionMalaria control activitiesMalaria control programmesPersonal protectionCase-control designChemoprevention treatmentMalaria chemopreventionSevere malariaSMC treatmentMean agePrimary exposureProtective efficacyResidual confoundingHealth facilitiesParasite densityCombining 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
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