Otieno, Lucas; Guerra Mendoza, Yolanda; Adjei, Samuel; Agbenyega, Tsiri; Agnandji, Selidji Todagbe; Aide, Pedro; Akoo, Pauline; Ansong, Daniel; Asante, Kwaku Poku; Berkley, James A; +27 more... Gesase, Samwel; Hamel, Mary J; Hoffman, Irving; Kaali, Seyram; Kamthunzi, Portia; Kariuki, Simon; Kremsner, Peter; Lanaspa, Miguel; Lell, Bertrand; Lievens, Marc; Lusingu, John; Malabeja, Anangisye; Masoud, Nahya Salim; Mtoro, Ali Takadir; Njuguna, Patricia; Ofori-Anyinam, Opokua; Otieno, Godfrey Allan; Otieno, Walter; Owusu-Agyei, Seth; Schuerman, Lode; Sorgho, Hermann; Tanner, Marcel; Tinto, Halidou; Valea, Innocent; Vandoolaeghe, Pascale; Sacarlal, Jahit; Oneko, Martina; (2019) Safety 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. Vaccine, 38 (4). pp. 897-906. ISSN 0264-410X DOI: https://doi.org/10.1016/j.vaccine.2019.10.077
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Abstract
BACKGROUND: 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 anti-circumsporozoite (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 vaccination-related. 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT00866619.
Item Type | Article |
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Faculty and Department | Faculty of Infectious and Tropical Diseases > Dept of Disease Control |
PubMed ID | 31708182 |
Elements ID | 141412 |