- A dose escalation/vaccination phase in which both dose levels were 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, were 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 were included.
Official Title: A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-escalation Clinical Study Evaluating Safety, Tolerability and Immunogenicity of Two Dose Levels of Recombinant Adenoviral Serotype Ad35 and Serotype Ad26 Vectors Expressing the Malaria Plasmodium Falciparum Circumsporozoite Antigen Administered as Heterologous Prime-boost Regimen, and Assessing Protective Efficacy of the Higher Dose in a Malaria Challenge Model in Unblinded Conditions
Outcomes/Next steps: Findings were presented at the 2012 Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH). Based on the outcomes of this study, MVI did not make further investments in this project.
ClinicalTrials.gov Identifier: NCT01397227