An effective malaria vaccine affects the risk of malaria directly, through the vaccine-induced immune response (the primary effect), and indirectly, as a consequence of reduced exposure to malaria infection and disease, leading to slower acquisition of natural immunity (the secondary effect). The beneficial primary effect may be offset by a negative secondary effect, resulting in a smaller or nil composite effect. Reports of malaria vaccine trials usually present only the composite effect. We aimed to demonstrate how the primary and secondary effects can also be estimated from trial data.
RTS,S/AS01E malaria vaccine contains the hepatitis B virus surface antigen and may thus serve as a potential hepatitis B vaccine. To evaluate the impact of RTS,S/AS01E when implemented in the Expanded Program of Immunization, infants 8–12 weeks old were randomized to receive either RTS,S/AS01E or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type b, trivalent oral poliovirus, pneumococcal non-typeable Haemophilus influenzae protein D conjugate and human rotavirus vaccine.
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.