Long‐Term Safety and Efficacy of the RTS,S/AS02A Malaria Vaccine in Mozambican Children

Abstract

These results show evidence that RTS,S/AS02A maintained protection during the 45-month surveillance period, and they highlight the feasibility of developing an effective vaccine against malaria. In combination with other malaria-control measures, such a vaccine could greatly contribute to reducing the intolerable global burden of this disease. Trial registration. ClinicalTrials.gov identifiers NCT00197041 and NCT00323622 .

First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children

“…However, varying study designs and statistical methods have led to different interpretations of the dynamics of efficacy over time, with some studies suggesting persistent protection and others suggesting waning protection. 7,[21][22][23][24][25] Decreasing protection over time could reflect waning immunity, acquisition of natural immunity in the control group, or heterogeneity of exposure. 26 Further follow-up and evaluation of the effect of a booster dose will provide a better understanding of the relative contribution of these factors.…”

Preclinical Vaccine Study of Plasmodium vivax Circumsporozoite Protein Derived-Synthetic Polypeptides Formulated in Montanide ISA 720 and Montanide ISA 51 Adjuvants

“…43,44 Additionally, anti-CS antibodies appear to be associated with protection against natural exposure of vaccinated 45,46 and non-vaccinated human volunteers. 47,48 Although a recent study indicates that there appears to be no association between levels of anti-CS antibodies and protection, 49 a possible explanation for these discrepancies may be the different antigens used for antibody detection.…”

From the circumsporozoite protein to the RTS,S/AS candidate vaccine

“…5,6 Crucially, sustained clinical benefit against all clinical episodes of malaria [26% (95% CI: 12, 37) p ≤ 0.001] together with prevention of severe malaria [38% (95% CI: 3, 61) p = 0.045] was demonstrated over 45 months of surveillance. 57 Furthermore, at Month 45, the prevalence of P. falciparum parasites was 34% lower in recipients of RTS,S/ AS02 A than of control vaccine (12% vs. 19%, p = 0.004). As in the adult trial conducted in The Gambia, vaccine-induced primary immunization (≅20 months from first dose); primary course without boost; comparator group.…”