11 August 2011 - Rockville, Maryland USA/London - Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) today announced the start of a Phase IIb proof-of-concept efficacy trial of a new investigational tuberculosis (TB) vaccine that involves people living with HIV. The trial will be conducted at research sites in Senegal and South Africa with primary funding support from the European and Developing Countries Clinical Trials Partnership (EDCTP).
This is the first proof-of-concept efficacy trial in people infected with HIV using MVA85A, which is being developed by OETC (a joint venture between the University of Oxford and Emergent BioSolutions) and Aeras. It is expected that the trial will generate important safety, immunogenicity and efficacy data about this vaccine.
The trial will test the vaccine candidate in approximately 1 400 adults aged 18-50 who are living with HIV. The study will be led by the UK Medical Research Council in The Gambia, Aeras, and the University of Oxford, and conducted at two sites by the University of Cape Town (UCT) Institute of Infectious Disease and Molecular Medicine in Khayelitsha, South Africa and Laboratoire de Bacteriologie-Virologie du Centre Hospitalier Universitaire Aristide Le Dantec in Dakar, Senegal. This follows the first proof-of-concept clinical trial of the same candidate TB vaccine, which recently reached full enrollment with almost 3,000 infant participants in South Africa.