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dc.contributor.authorOtieno, Lucas-
dc.contributor.authorGuerra Mendoza, Yolanda-
dc.contributor.authorAdjei, Samuel-
dc.contributor.authorAgbenyega, Tsiri-
dc.contributor.authorAgnandji, Selidji Todagbe-
dc.contributor.authorAide, Pedro-
dc.contributor.authorAkoo, Pauline-
dc.contributor.authorAnsong, Daniel-
dc.contributor.authorAsante, Kwaku Poku-
dc.contributor.authorBerkley, James A.-
dc.contributor.authorGesase, Samwel-
dc.contributor.authorHamel, Mary J.-
dc.contributor.authorHoffman, Irving-
dc.contributor.authorKaali, Seyram-
dc.contributor.authorKamthunzi, Portia-
dc.contributor.authorKariuki, Simon-
dc.contributor.authorKremsner, Simon-
dc.contributor.authorLanaspa, Miguel-
dc.contributor.authorLell, Bertrand-
dc.contributor.authorLievens, Marc-
dc.contributor.authorLusingu, John-
dc.contributor.authorMalabeja, Anangisye-
dc.contributor.authorMasoud, Nahya Salim-
dc.contributor.authorMtoro, Ali Takadir-
dc.contributor.authorNjuguna, Patricia-
dc.contributor.authorOfori-Anyinam, Opokua-
dc.contributor.authorOtieno, Godfrey Allan-
dc.contributor.authorOtieno, Walter-
dc.contributor.authorOwusu-Agyei, Seth-
dc.contributor.authorSchuerman, Lode-
dc.contributor.authorSorgho, Hermann-
dc.contributor.authorTanner, Marcel-
dc.contributor.authorTinto, Halidou-
dc.contributor.authorValea, Innocent-
dc.contributor.authorVandoolaeghe, Pascale-
dc.contributor.authorSacarlal, Jahit-
dc.contributor.authorOneko, Martina-
dc.description.abstractBackground: We assessed the safety and immunogenicity of the RTS,S/AS01 malaria vaccine in a subset of children identified as HIV-infected during a large phase III randomized controlled trial conducted in seven sub-Saharan African countries. Methods: Infants 6–12 weeks and children 5–17 months old were randomized to receive 4 RTS,S/AS01 doses (R3R group), 3 RTS,S/AS01 doses plus 1 comparator vaccine dose (R3C group), or 4 comparator vaccine doses (C3C group) at study months 0, 1, 2 and 20. Infants and children with WHO stage III/IV HIV disease were excluded but HIV testing was not routinely performed on all participants; our analyses included children identified as HIV-infected based on medical history or clinical suspicion and confirmed by polymerase chain reaction or antibody testing. Serious adverse events (SAEs) and anticircumsporozoite (CS) antibodies were assessed. Results: Of 15459 children enrolled in the trial, at least 1953 were tested for HIV and 153 were confirmed as HIV-infected (R3R: 51; R3C: 54; C3C: 48). Among these children, SAEs were reported for 92.2% (95% CI: 81.1–97.8) in the R3R, 85.2% (72.9–93.4) in the R3C and 87.5% (74.8–95.3) in the C3C group over a median follow-up of 39.3, 39.4 and 38.3 months, respectively. Fifteen HIV-infected participants in each group (R3R: 29.4%, R3C: 27.8%, C3C: 31.3%) died during the study. No deaths were considered vaccinationrelated. In a matched case-control analysis, 1 month post dose 3 anti-CS geometric mean antibody concentrations were 193.3 EU/mL in RTS,S/AS01-vaccinated HIV-infected children and 491.5 EU/mL in RTS,S/ AS01-vaccinated immunogenicity controls with unknown or negative HIV status (p = 0.0001). Conclusions: The safety profile of RTS,S/AS01 in HIV-infected children was comparable to that of the comparator (meningococcal or rabies) vaccines. RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status.-
dc.format.extent10 p.-
dc.relation.isformatofReproducció del document publicat a:
dc.relation.ispartofVaccine, 2019, vol. 38, num. 4, p. 897-906-
dc.rightscc by (c) GlaxoSmithKline Biologicals S.A., 2019-
dc.subject.classificationVacuna de la malària-
dc.subject.classificationPersones seropositives-
dc.subject.classificationÀfrica subsahariana-
dc.subject.otherMalaria vaccine-
dc.subject.otherHIV-positive persons-
dc.subject.otherSub-Saharan Africa-
dc.titleSafety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa-
Appears in Collections:Articles publicats en revistes (ISGlobal)

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