Initiation date: 2011
End date: 2012
Past project
Project description: A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model *
 
The purpose of this study was 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 was carried out in three phases:
 
  1. A dose escalation/vaccination phase in which both dose levels were 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, were 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 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

Enrollment: 36

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

View detailed study record on clinicaltrials.gov

 

Acknowledgements
This project was made possible in part through support provided by the Infectious Disease Division, Bureau for Global Health, US Agency for International Development, under the terms of Cooperative Agreement No. GHS-A-00-04-00016-00. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the US Agency for International Development. The vaccines were manufactured by Crucell Holland BV, Leiden, Netherlands under a Division of Microbiology and Infectious Diseases-supported contract N01-AI05421, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
 
*Source: https://clinicaltrials.gov/ct2/show/record/NCT01397227; last accessed November 3, 2016.