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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
Àfrica subsahariana
Malaria vaccine
HIV-positive persons
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.
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It is part of: Vaccine, 2019, vol. 38, num. 4, p. 897-906
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ISSN: 0264-410X
Appears in Collections:Articles publicats en revistes (ISGlobal)

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