A trial to test whether a new tuberculosis vaccine developed at Oxford University is effective in people with HIV has begun in Senegal and South Africa.
Around 1,400 adults with HIV will receive the vaccine in the trial, which will test for the first time whether the new vaccine offers protection against TB for those who are HIV positive.
The Phase IIb trial will also gather important data on the safety of the vaccine and the immune responses it generates.
‘It is great to see the vaccine candidate we initially developed at Oxford University reach this stage of clinical trials,’ said Dr Helen McShane of the Jenner Institute 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.’
Tuberculosis kills 1.7 million people per year. People with HIV are at much greater risk, and are an important group that could benefit from a new TB vaccine.
In 2008, there were an estimated 1.4 million new cases of TB among people with HIV, and TB accounted for 23 percent of AIDS-related deaths. HIV-positive people living in countries with high TB prevalence are 20 times more likely to develop the disease than those who are HIV-negative.
The BCG vaccine, the only currently-licensed vaccine against TB, is not effective in preventing the most common form of the disease, adult pulmonary TB.
The new TB vaccine was developed at the University of Oxford by Dr Helen McShane, working with Dr Sarah Gilbert and Professor Adrian Hill. It is designed to boost the body’s immune response – via cells called T cells – which has already been stimulated or primed by the BCG vaccine.
The Oxford vaccine is the most clinically advanced of any new vaccine currently being developed to combat TB. A clinical trial is well under way in South Africa to establish whether the vaccine offers protection against TB in infants. The results of that trial may be available as early as next year.
The vaccine was licensed in July 2008 to a new partnership between Oxford University and the biotech company Emergent BioSolutions, called the Oxford-Emergent Tuberculosis Consortium (OETC).
OETC is working with Aeras, a non-profit organization supporting TB vaccine development with funds from the Bill & Melinda Gates Foundation and elsewhere, to guide the development of the vaccine through late-stage clinical trials.
‘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,’ said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. ‘This trial is particularly critical because of its focus on adults living with HIV.’
‘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, the trial sponsor.
The new study in people with HIV will be led by the University of Oxford, the Medical Research Council in The Gambia, and Aeras.
The trial will be conducted at two sites: in Khayelitsha, South Africa led by the University of Cape Town; and in Dakar, Senegal by the Centre Hospitalier Universitaire Aristide Le Dantec.
Significant funding for the trial is being provided by the European and Developing Countries Clinical Trials Partnership (EDCTP). The partnership’s executive director Professor Charles Mgone 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.’