Via de deurmat: January
Aeras Newsletter
Phase II Clinical Trial in Kenya Advances
Sixty-four infants have been enrolled, to date, in a Phase II tuberculosis vaccine clinical trial in the Siaya District, Nyanza Province of Western Kenya. The candidate vaccine is AERAS-402/Crucell Ad35, and is designed as a booster to the currently available TB vaccine. The Kenya study is led by KEMRI/CDC, a joint research project of the Kenya Medical Research Institute and the Centers for Disease Control and Prevention.
The trial in Kenya is the first phase of a multi-center clinical trial co-sponsored by Aeras and is designed to evaluate dosing regimens for the second phase of the trial. The second phase is designed to evaluate the efficacy of the candidate vaccine and includes expansion of the study into additional African research locations. Significant support for this Phase II trial comes from the European and Developing Country Clinical Trials Partnership (EDCTP) through a consortium of African research institutes, which includes KEMRI/CDC.
Professor Charles Mgone, the EDCTP Executive Director, commenting on the project noted that, "it underpins the principle of EDCTP working in partnership with the European Commission, Member States, Product Development Partners and other Public and Private Partnerships to facilitate advancements in clinical research to fight HIV/AIDs, Malaria and Tuberculosis." EDCTP is currently funding 18 projects on TB vaccines and diagnostics. Aeras is a contributing partner on four of these projects.