- Assess the safety and reactogenicity of Ad35.CS.01/Ad26.CS.01 in malaria-naïve adults by monitoring for occurrence of solicited signs and symptoms, occurrence of unsolicited symptoms, and the occurrence of serious adverse events during the study period.
- Quantify humoral immune response via antibody titer, and evaluate experimental human malaria infection as a reliable and reproducible model in assessing malaria vaccine candidates.
Outcomes/Next steps: Findings were presented at the 2012 Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH).
Ad35.CS.01/Ad26.CS.01 was found to be well-tolerated, with low systemic reactogenicity in subjects. Although the vaccine was immunogenic, it demonstrated suboptimal efficacy after challenge. However, the experimental human malaria infection model induced highly reproducible infection in all subjects, thereby demonstrating its potential as a useful tool in assessing malaria vaccine candidates.
Based on the outcomes of this study, the PATH Malaria Vaccine Initiative did not make further investments.