Ad26.CS.01(Crucell Holland BV)

The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the protective efficacy of the higher dose level in an experimental malaria challenge.
The study will be in 3 phases:
a dose escalation / vaccination phase in which both dose levels will be tested
a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01 5x10^10 vp dose level, together with six infectivity control subjects, will be exposed to experimental challenge with Plasmodium falciparum
a long term follow up phase in which all subjects who received active vaccine from both dose levels and/or malaria challenge will be included