TB vaccine MVA85A trial: first volunteers enrolled in Senegal
Since 4 August 2011 volunteers are being enrolled in the Senegal site of the candidate TB vaccine MVA85A clinical trial. This study is conducted in Senegal and South Africa and designed to evaluate whether a new tuberculosis vaccine will boost immunity to the TB causing bacteria and reduce sickness from tuberculosis. Aeras and the Oxford-Emergent Tuberculosis Consortium (OECT) announced the start of this Phase IIb proof-of-concept efficacy trial of the new tuberculosis vaccine MVA85A today. The trial is primarily funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
Professor Charles Mgone, the Executive Director of EDCTP said, “The TB and HIV co-epidemic is devastating, requiring a concerted global response. EDCTP in partnership with AERAS, Oxford-Emergent Tuberculosis Consortium and others is committed to accelerate research and development of this promising vaccine against tuberculosis by co-financing the clinical trial as an essential part in its evaluation.”
The study will test the vaccine candidate in approximately 1400 adults age 18-50 who are infected with HIV. People infected with HIV are at far greater risk of developing TB disease than HIV-negative people. 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 the Laboratoire de Bacteriologie-Virologie du Centre Hospitalier Universitaire Aristide Le Dantec in Dakar, Senegal. The study has been approved by the Medicines Control Council of South Africa, the South African Department of Health, and the Comité National d’Ethique pour la Recherche en Santé (CNERS) in Senegal. The Scientific Institute of Public Health (WIV-ISP) in Belgium, which first identified the Ag85A as a possible vaccine candidate, is providing in-kind laboratory services for the study.
Further information
About Aeras
Aeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras has invented or supported the development of six TB vaccine candidates to date, five of which are currently undergoing Phase I and Phase II clinical testing in Africa, Asia and North America. Aeras receives funding from private foundations and governments. Aeras is based in Rockville, Maryland and Cape Town, South Africa.
About OETC
The Oxford-Emergent Tuberculosis Consortium Ltd (“OETC”) is a joint venture between the University of Oxford and Emergent BioSolutions company. OETC was formed with the aim of developing the MVA85A TB vaccine to meet both developed and developing country health needs.
About EDCTP
The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union member states plus Norway and Switzerland with 47 sub-Saharan African countries. The aim of the programme is to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through promoting the integration of national programmes of EDCTP European Member States and development of a genuine partnership with African counterparts.