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.
Dr. Grace Kiringa study coordinator for the AERAS-402/Crucell Ad35 trials in Kenya, says “the main purpose of the study at this point is to confirm and evaluate the safety profile of this new TB vaccine. So far, in previous studies that have been done in healthy adults, adults living with HIV and in healthy infants there have been no serious adverse events reported. And so, to the best of our knowledge, the vaccine is safe. This is extremely promising and critical to finding a new vaccine that will help put an end to the TB epidemic.”
She adds that while HIV is a health priority in Kenya, it has also fueled a resurgence of TB which is now the leading cause of death in HIV patients. Dr. Kiringa notes, “The efforts to find an effective TB vaccine should be concurrent with HIV vaccine efforts because as you fight one, you also fight the other.”
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.
Prof 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.
