# name
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

# metadata.dc.description.abstract[].value
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.

# metadata.dc.rights[].value
cc by (c) GlaxoSmithKline Biologicals S.A., 2019

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
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