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Title: | 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 |
Author: | Otieno, Lucas Guerra Mendoza, Yolanda Adjei, Samuel Agbenyega, Tsiri Agnandji, Selidji Todagbe Aide, Pedro Carlos Paulino Akoo, Pauline Ansong, Daniel Asante, Kwaku Poku Berkley, James A. Gesase, Samwel Hamel, Mary J. Hoffman, Irving Kaali, Seyram Kamthunzi, Portia Kariuki, Simon Kremsner, Simon 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 |
Keywords: | Vacuna de la malària Persones seropositives Infants Àfrica subsahariana Malaria vaccine HIV-positive persons Children Sub-Saharan Africa |
Issue Date: | 22-Jan-2020 |
Publisher: | Elsevier |
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 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. |
Note: | Reproducció del document publicat a: http://dx.doi.org/10.1016/j.vaccine.2019.10.077 |
It is part of: | Vaccine, 2019, vol. 38, num. 4, p. 897-906 |
URI: | http://hdl.handle.net/2445/148352 |
Related resource: | http://dx.doi.org/10.1016/j.vaccine.2019.10.077 |
ISSN: | 0264-410X |
Appears in Collections: | Articles publicats en revistes (ISGlobal) |
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