A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
Summary
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: 1. a dose escalation / vaccination phase in which both dose levels will be tested 2. 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 3. 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
Timeline
- Start
- 2011-06
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.CS.01 | Unknown | 1e+10 unknown | Other |
| Subject | Ad26.CS.01 | Unknown | 5e+10 unknown | Other |
| Subject | Ad35.CS.01 | Vaccine | 1e+10 unknown | Other |
| Subject | Ad35.CS.01 | Vaccine | 5e+10 unknown | Other |