Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso

Summary

The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.

Timeline

Start

2010-04

Primary completion

2011-12

Completion

2011-12

Publications

• Results Ouedraogo A, Tiono AB, Kargougou D, Yaro JB, Ouedraogo E, Kabore Y, Kangoye D, Bougouma EC, Gansane A, Henri N, Diarra A, Sanon S, Soulama I, Konate AT, Watson NL, Brown V, Hendriks J, Pau MG, Versteege I, Wiesken E, Sadoff J, Nebie I, Sirima SB. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One. 2013 Nov 11;8(11):e78679. doi: 10.1371/journal.pone.0078679. eCollection 2013.

Drugs

Indications