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In this ongoing phase 3 study of over 6000 infants (6 to 12 weeks of age) at 11 centers in Africa, the RTS,S/AS01 vaccine had 30% efficacy in preventing the first episode of clinical malaria and 26% efficacy in preventing severe malaria over a period of 14 months. Considerable gains have been achieved in malaria control during the past decade. 1 , 2 Nonetheless, malaria remains a major public health concern. In 2010, an estimated 216 million cases of malaria and 655,000 malaria-related deaths occurred, with the vast majority of deaths occurring in African children. 1 The RTS,S/AS01 candidate malaria vaccine targets the pre-erythrocytic stage of the Plasmodium falciparum parasite. It was developed to reduce clinical and severe malaria in African children. Ideally, it would be administered through the well-established Expanded Program on Immunization (EPI). In 2011, we reported the results for the first coprimary end point from an ongoing phase . . .

Each year, about 225 million persons have malaria, with some 781,000 associated deaths. In a preliminary report of a phase 3 trial in African children, the RTS,S/AS01 malaria vaccine had about 50% efficacy against incident malaria and 34% efficacy against severe disease. Each year, malaria occurs in approximately 225 million persons worldwide, and 781,000 persons, mostly African children, die from the disease. 1 During the past decade, the scale-up of malaria-control interventions has resulted in considerable reductions in morbidity and mortality associated with malaria in parts of Africa. 2 , 3 However, malaria continues to pose a major public health threat. A malaria vaccine, deployed in combination with current malaria-control tools, could play an important role in future control and eventual elimination of malaria in Africa. 4 The RTS,S vaccine that targets the circumsporozoite protein and is given with an adjuvant system (AS01 or AS02) has . . .

•The RTS,S/AS01 malaria vaccine was assessed in a phase 3 trial in sub-Saharan Africa.•We evaluated the vaccine in a subset of children identified as HIV+ in this trial.•The safety of RTS,S/AS01 in HIV+ children was similar to that of comparator vaccines.•RTS,S/AS01 was immunogenic in HIV+ children.•Antibody levels in HIV+ children were lower than in children with unknown HIV status. 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. 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. 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). 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.