NIAID expands TB vaccine candidate AERAS-402/Crucell Ad35 clinical trial
The National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH) joins the TB vaccine candidate AERAS-402/Crucell Ad35 clinical trial as a partner. Following a new policy NIH is leveraging for the first time its HIV/AIDS clinical trial networks to advance a tuberculosis (TB) vaccine candidate. The current trial is expanding to additional sites in sub-Saharan Africa. It is expected to enroll up to 4,000 infants. The trial aims to evaluate the safety and efficacy of a TB vaccine candidate developed by Aeras and the Dutch biopharmaceutical company Crucell in HIV-uninfected infants and also received significant support from EDCTP and European Member States.
Dr Hassan Mahomed from the University of Cape Town in South Africa leads this project to evaluate the immunogenicity and efficacy of the AERAS-402/Crucell Ad35 TB candidate vaccine in HIV-uninfected infants in the four sites. The Perinatal HIV Research Unit (PHRU) in Soweto, South Africa is the first NIAD-supported site to join the clinical trial, and it may expand to additional NIAID field sites in sub-Saharan Africa. The clinical trial began in October 2010 and has already enrolled infants in Kenya, South Africa and Mozambique. Preliminary results are expected in late 2014.
The project ensures that for the next five years the original four trial sites will have the infrastructural capacity to conduct Phase IIB and Phase III trials of new TB vaccines. These sites are the South African Tuberculosis Vaccine Initiative (South Africa), KEMRI/CDC Field Research Station (Kenya), the Manhiça Health Research Centre (Mozambique), and the Kampala Field Site, Makerere University (Uganda).
More information:
Link to the Press release by Aeras
Link to the NIAID website