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): 897-906, 2020 01 22.
Article
de En
| MEDLINE
| ID: mdl-31708182
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 (pâ¯=â¯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.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Vaccins synthétiques
/
Infections à VIH
/
Vaccination
/
Paludisme à Plasmodium falciparum
/
Vaccins contre le paludisme
Type d'étude:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limites:
Female
/
Humans
/
Infant
/
Male
Pays/Région comme sujet:
Africa
Langue:
En
Journal:
Vaccine
Année:
2020
Type de document:
Article