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
2018
Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial
Drugs T, Sagara I, Beavogui A, Zongo I, Soulama I, Borghini-Fuhrer I, Fofana B, Traore A, Diallo N, Diakite H, Togo A, Koumare S, Keita M, Camara D, Somé A, Coulibaly A, Traore O, Dama S, Goita S, Djimde M, Bamadio A, Dara N, Maiga H, Sidibe B, Dao F, Coulibaly M, Alhousseini M, Niangaly H, Sangare B, Diarra M, Coumare S, Kabore M, Ouattara S, Barry A, Kargougou D, Diarra A, Henry N, Soré H, Bougouma E, Thera I, Compaore Y, Sutherland C, Sylla M, Nikiema F, Diallo M, Dicko A, Picot S, Borrmann S, Duparc S, Miller R, Doumbo O, Shin J, Gil J, Björkman A, Ouedraogo J, Sirima S, Djimde A. Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial. The Lancet 2018, 391: 1378-1390. PMID: 29606364, PMCID: PMC5889791, DOI: 10.1016/s0140-6736(18)30291-5.Peer-Reviewed Original ResearchConceptsArtemisinin-based combination therapyFirst-line artemisinin-based combination therapyArtemether-lumefantrineDay 28Day 42Study drugUncomplicated malariaMalaria episodesEligible participantsIncidence ratePan African Clinical Trials RegistryUncomplicated P falciparum malariaCurrent first-line therapyAfrican Clinical Trials RegistryDeveloping Countries Clinical Trials PartnershipDihydroartemisinin-piperaquine treatmentFirst malaria episodeP falciparum malariaUncomplicated malaria episodesFirst-line therapyHistory of feverClinical Trials RegistryNon-falciparum speciesMild transient elevationUK Medical Research Council
2017
Comparison of effectiveness of two different artemisinin-based combination therapies in an area with high seasonal transmission of malaria in Burkina Faso
Sondo P, Derra K, Nakanabo S, Tarnagda Z, Kazienga A, Valea I, Sorgho H, Ouédraogo J, Guiguemdé T, Tinto H. Comparison of effectiveness of two different artemisinin-based combination therapies in an area with high seasonal transmission of malaria in Burkina Faso. Annals Of Parasitology 2017, 63: 127-131. PMID: 28822205, DOI: 10.17420/ap6302.96.Peer-Reviewed Original ResearchConceptsArtemether-lumefantrine groupsCure rateArtemether-lumefantrineHigh incidenceDifferent artemisinin-based combination therapiesMalaria transmissionPost-treatment prophylactic effectRandomized open-label trialArtemisinin-based combination therapyArtesunate-amodiaquine treatmentHigh seasonal transmissionUncorrected cure ratesOpen-label trialUncomplicated falciparum malariaMerozoite surface protein 1Surface protein 1Antimalarial regimensArtesunate-AmodiaquinePCR adjustmentLabel trialUncomplicated malariaFalciparum malariaMalaria episodesRecurrent parasitaemiaComparison of effectiveness
2015
Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial
Sagara I, Beavogui A, Zongo I, Soulama I, Borghini-Fuhrer I, Fofana B, Camara D, Somé A, Coulibaly A, Traore O, Dara N, Kabore M, Thera I, Compaore Y, Sylla M, Nikiema F, Diallo M, Dicko A, Gil J, Borrmann S, Duparc S, Miller R, Doumbo O, Shin J, Bjorkman A, Ouedraogo J, Sirima S, Djimdé A. Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial. The Lancet Infectious Diseases 2015, 16: 189-198. PMID: 26601738, PMCID: PMC4726763, DOI: 10.1016/s1473-3099(15)00318-7.Peer-Reviewed Original ResearchConceptsSubstudy analysisFirst episodeFirst treatmentArtemisinin-based combination treatmentDeveloping Countries Clinical Trials PartnershipPrimary safety endpointPyronaridine-artesunate efficacyHistory of feverIncidence of hepatotoxicityAdverse event frequencyExclusion of patientsUK Medical Research CouncilMedical Research CouncilParasitological responseSafety endpointArtemether-lumefantrineMalaria episodesTreat analysisAfrican patientsMalaria treatmentClinical trialsMalaria VentureLaboratory valuesAlanine aminotransferaseHealth facilitiesEffectiveness 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 rateAnemia And Iron Supplementation Is Not Associated with Malaria in Young Burkinabe Children
Some J, Abbeddou S, Jimenez E, Ouedraogo Z, Ouedraogo J, Brown K, Hess S. Anemia And Iron Supplementation Is Not Associated with Malaria in Young Burkinabe Children. The FASEB Journal 2015, 29 DOI: 10.1096/fasebj.29.1_supplement.757.9.Peer-Reviewed Original ResearchLipid-based nutrient supplementsRapid diagnostic testsYoung Burkinabe childrenBurkinabe childrenIron supplementationFe supplementsPositive malaria rapid diagnostic testPositive rapid diagnostic testMalaria rapid diagnostic testsRandomized clinical trialsIncidence of malariaMo of ageMalaria episodesAntimalarial treatmentSevere anemiaModerate anemiaClinical trialsAnthelminthic treatmentHome visitsMalaria diagnosisHemoglobin concentrationMalaria incidenceIron treatmentDiagnostic testsMalariaTreated Malaria Does Not Affect Physical Growth And Hemoglobin Concentration of Young Children in Burkina Faso
Some J, Abbeddou S, Jimenez E, Hess S, Ouedraogo Z, Guissou R, Vosti S, Ouedraogo J, Brown K. Treated Malaria Does Not Affect Physical Growth And Hemoglobin Concentration of Young Children in Burkina Faso. The FASEB Journal 2015, 29 DOI: 10.1096/fasebj.29.1_supplement.757.7.Peer-Reviewed Original ResearchLipid-based nutrient supplementationRapid diagnostic testsPhysical growthHemoglobin concentrationZ-scoreYoung Burkinabe childrenLength z-scoreCause of anemiaAssociation of malariaAge z-scoreYoung childrenMo of ageMalaria episodesMorbidity assessmentBurkinabe childrenMean changeMalariaDiagnostic testsDifferent dosesEarly childhoodChildrenDiarrheaFeverEpisodesFrequency categories
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
2008
Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial
Zeba A, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemdë R, Hamer D, Mokhtar N, Ouedraogo J. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutrition Journal 2008, 7: 7. PMID: 18237394, PMCID: PMC2254644, DOI: 10.1186/1475-2891-7-7.Peer-Reviewed Original ResearchConceptsSupplemented groupZinc supplementationVitamin APlacebo groupMalaria episodesSingle doseRandomized double-blind trialFirst malaria episodeRisk of feverDouble-blind trialPlacebo-controlled trialCases of feverDaily zinc supplementationNormal immune functionRisk of infectionCross-sectional surveyMalaria control strategiesClinical malariaFever episodesMalaria morbidityMalaria casesMalaria parasite detectionImmune functionBlind trialConclusionThese results