Aeras, OETC announce initiation of new TB vaccine Phase IIb trial in patients with HIV

Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) announce today 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). 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).

TB is a leading cause of death for people infected with HIV and the second leading infectious disease killer in the world. 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 ages 18-50 who are infected 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.

"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," said Member of the European Parliament Michael Cashman. "I recently visited a clinical trial site of this vaccine candidate in infants in South Africa, and I was impressed with the progress. 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, 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."

Tuberculosis kills 1.7 million people per year, and more than two billion people worldwide are infected with TB - approximately one out of every three people on the planet. People infected with HIV living in countries with high TB prevalence are 20 times more likely to develop TB than those who are HIV-negative. In 2008, there were an estimated 1.4 million new cases of TB among persons with HIV infection, and TB accounted for 23 percent of AIDS-related deaths, according to the World Health Organization (WHO). The Bacille Calmette-Guérin (BCG) vaccine, the only currently-licensed vaccine against TB, is not effective in preventing adult pulmonary TB, the most common form of the disease.

"A new, more effective TB vaccine would be game-changing in international efforts to eliminate TB globally by 2050," said Jim Connolly, President and Chief Executive Officer of Aeras. "Studies have already shown that this promising vaccine has an acceptable safety profile and stimulates strong immune responses in HIV-infected individuals."

Aeras is the trial sponsor, and significant funding is provided by EDCTP, a pan-European body that supports multicenter projects which combine clinical trials, capacity building and networking. This 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 antigen 85A for possible use in a vaccine candidate, is providing in-kind laboratory services for the study.

"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," said Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions.

"It is great to see the vaccine candidate we initially developed at Oxford University reach this stage of clinical trials," said Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow at the University of Oxford. "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."