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
2021
Hepatic safety of repeated treatment with pyronaridine‐artesunate versus artemether–lumefantrine in patients with uncomplicated malaria: a secondary analysis of the WANECAM 1 data from Bobo-Dioulasso, Burkina Faso
Compaoré Y, Zongo I, Somé A, Barry N, Nikiéma F, Kaboré T, Ouattara A, Kabré Z, Wermi K, Zongo M, Yerbanga R, Sagara I, Djimdé A, Ouédraogo J. Hepatic safety of repeated treatment with pyronaridine‐artesunate versus artemether–lumefantrine in patients with uncomplicated malaria: a secondary analysis of the WANECAM 1 data from Bobo-Dioulasso, Burkina Faso. Malaria Journal 2021, 20: 64. PMID: 33514368, PMCID: PMC7847156, DOI: 10.1186/s12936-021-03593-6.Peer-Reviewed Original ResearchConceptsHepatic adverse eventsArtemether-lumefantrineAL armAdverse eventsElevated ALTMalaria episodesUncomplicated malariaHepatic safetyDirect bilirubinPA armFirst-line anti-malarial drugHepatic safety profileUncomplicated malaria episodesElevated total bilirubinBobo-DioulassoLogistic regression modelsAnti-malarial drugsAlkaline phosphataseSubsequent malariaUnscheduled daysStudy armsSafety profileResultsA totalClinical trialsTotal bilirubin
2019
Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention
Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, Diarra M, Barry A, Tapily A, Nikiema F, Yerbanga S, Coumare S, Thera I, Traore A, Milligan P, Tinto H, Doumbo O, Ouedraogo J, Greenwood B. Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention. New England Journal Of Medicine 2019, 380: 2197-2206. PMID: 30699301, DOI: 10.1056/nejmoa1811400.Peer-Reviewed Original ResearchMeSH KeywordsAmodiaquineAnti-Bacterial AgentsAntimalarialsAzithromycinBurkina FasoChild MortalityChild, PreschoolDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationFemaleHospitalizationHumansIncidenceInfantInfant MortalityMalariaMaleMaliMass Drug AdministrationParasitemiaPyrimethamineSulfadoxineConceptsSeasonal malaria chemopreventionAddition of azithromycinMalaria transmission seasonMalaria chemopreventionHospital admissionAnnual malaria transmission seasonsUpper respiratory tract infectionNonmalarial febrile illnessesPrimary end pointRespiratory tract infectionsAntimalarial agentsLow disease burdenYears of ageMonths of ageAzithromycin groupCause mortalityPlacebo groupAdverse eventsFebrile illnessMalaria parasitemiaTract infectionsTreat analysisElective surgeryDisease burdenGastrointestinal infections
2015
Effectiveness and safety of artemether–lumefantrine versus artesunate–amodiaquine for unsupervised treatment of uncomplicated falciparum malaria in patients of all age groups in Nanoro, Burkina Faso: a randomized open label trial
Sondo P, Derra K, Diallo-Nakanabo S, Tarnagda Z, Zampa O, Kazienga A, Valea I, Sorgho H, Owusu-Dabo E, Ouedraogo J, Guiguemde T, Tinto H. Effectiveness and safety of artemether–lumefantrine versus artesunate–amodiaquine for unsupervised treatment of uncomplicated falciparum malaria in patients of all age groups in Nanoro, Burkina Faso: a randomized open label trial. Malaria Journal 2015, 14: 325. PMID: 26289949, PMCID: PMC4545998, DOI: 10.1186/s12936-015-0843-8.Peer-Reviewed Original ResearchConceptsArtemisinin-based combination therapyOpen-label trialArtemether-lumefantrineYears of ageDrug intakeLabel trialDay 28Randomized open-label trialAge groupsNanoro health districtUncomplicated falciparum malariaMerozoite surface protein 1Primary health centersSurface protein 1Mode of administrationAnti-malarial drugsParents/guardiansParasitological responseUncomplicated malariaAdverse eventsFalciparum malariaMalaria episodesOlder patientsCombination therapyCure rate
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
2007
Randomized Comparison of Amodiaquine plus Sulfadoxine-Pyrimethamine, Artemether-Lumefantrine, and Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Burkina Faso
Zongo I, Dorsey G, Rouamba N, Dokomajilar C, Séré Y, Rosenthal P, Ouédraogo J. Randomized Comparison of Amodiaquine plus Sulfadoxine-Pyrimethamine, Artemether-Lumefantrine, and Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Burkina Faso. Clinical Infectious Diseases 2007, 45: 1453-1461. PMID: 17990228, DOI: 10.1086/522985.Peer-Reviewed Original ResearchConceptsUncomplicated Plasmodium falciparum malariaPlasmodium falciparum malariaFalciparum malariaArtemether-lumefantrineRecurrent parasitemiaUncomplicated P. falciparum malariaCombination antimalarial therapyEarly treatment failureSerious adverse eventsP. falciparum malariaDrug-resistant parasitesYears of ageMonths of ageAntimalarial regimenDihydroartemisinin-PiperaquineLumefantrine regimenAdverse eventsCombination regimensSulfadoxine-pyrimethamineRandomized comparisonTreatment failureNew regimenRecurrent malariaAntimalarial therapyTreatment groups
2005
Amodiaquine, sulfadoxine-pyrimethamine, and combination therapy for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso.
Zongo I, Dorsey G, Rouamba N, Dokomajilar C, Lankoande M, Ouedraogo J, Rosenthal P. Amodiaquine, sulfadoxine-pyrimethamine, and combination therapy for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso. American Journal Of Tropical Medicine And Hygiene 2005, 73: 826-32. PMID: 16282288, DOI: 10.4269/ajtmh.2005.73.826.Peer-Reviewed Original ResearchConceptsUncomplicated falciparum malariaFalciparum malariaTreatment failureEfficacy of amodiaquineEarly treatment failureSerious adverse eventsPatients 6 monthsRisk of recrudescenceEfficacy outcomesUncomplicated malariaAdverse eventsWHO criteriaAvailable therapiesCombination therapyAntimalarial therapyClinical failureNew infectionsAmodiaquineBurkina FasoTherapyRelative efficacyMalariaBobo-DioulassoPyrimethamineTrials