The start of a Phase IIb proof- of-concept efficacy trial of a new investigational tuberculosis (TB) vaccine that involves people living with the human immunodeficiency virus (HIV) was announced by Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC).
The trial, funded and supported primarily from the European and Developing Countries Clinical Trials Partnership (EDCTP) will be carried out at research sites in Senegal and South Africa and 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.
TB is the second highest infectious disease killer worldwide and the main cause of death for people infected with HIV. Researchers anticipate that the trial will provide important safety, immunogenicity and efficacy data about this vaccine.
The study will be directed by the UK Medical Research Council in The Gambia, Aeras, and the University of Oxford and carried out 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 in which approximately 1,400 HIV positive adults aged 18-50 will be tested with the vaccine.
The trial is the second phase of 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.
Following a recent visit to a clinical trial site of this vaccine candidate in infants in South Africa, Michael Cashman, Member of the European Parliament, was impressed with the progress and said:
"Clinical trials of new vaccines against tuberculosis must be an urgent priority on our agenda, as too many lives are lost to TB, especially among people living with HIV. I am anxious to see a new TB vaccine licensed, and I am proud that European Union Member States are investing in this critically-important work."
Professor Charles Mgone, Executive Director of EDCTP, added:
"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."
Tuberculosis claims 1.7 million lives per year with over two billion people infected worldwide, which relates to approximately one in three people on the planet.
HIV-positive people who live in countries with a high occurrence of TB are 20 times more likely to contract TB than those who are HIV-negative. According to the World Health Organization (WHO), 2008 registered an estimated 1.4 million new cases of TB among HIV-positive people, with TB being responsible for 23 percent of AIDS-related deaths.
The only vaccine currently-licensed against TB, the Bacille Calmette-Guérin (BCG) vaccine is ineffective in preventing adult pulmonary TB, which is the most common form of the disease.
Jim Connolly, President and Chief Executive Officer of Aeras, the trial sponsor, said:
"A new, more effective TB vaccine would be game-changing in international efforts to eliminate TB globally by 2050. Studies have already shown that this promising vaccine has an acceptable safety profile and stimulates strong immune responses in HIV-infected individuals."
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 have approved the study. One of the main sponsors is EDCTP, a pan-European body that supports multi-center projects, which combine clinical trials, capacity building and networking. In-kind laboratory services for the study will be provided by The Scientific Institute of Public Health (WIV-ISP) in Belgium, which first identified the antigen 85A for possible use in a vaccine candidate.
Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions said:
"Together with our partners, Emergent BioSolutions is proud to be leading the development of a new vaccine to defeat TB, one of the world's deadliest infectious diseases. This trial is particularly critical because of its focus on adults living with HIV. If we are successful, MVA85A will help make the dream of a world free from TB a reality."
Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow at the University of Oxford, added:
"It is great to see the vaccine candidate we initially developed at Oxford University reach this stage of clinical trials. In the next few years we should begin to get results on how effective the vaccine is in protecting those who are most at risk of TB. It's our hope that this vaccine will turn out to be a powerful new weapon to combat TB in the parts of the world that need it most."
Written by Petra Rattue