Tamar Kahn
20 October 2008
Cape Town — Local scientists have started enrolling volunteers in a phase 2 clinical trial to test the safety of a potential tuberculosis (TB) vaccine developed by Dutch pharmaceutical company Crucell and the not-for-profit Aeras Global TB Vaccine Foundation.
SA has battled with large numbers of TB patients for many years and the crisis has deepened in the past decade with the growing HIV/AIDS epidemic. HIV weakens an infected person's immune system, making them more susceptible to TB.
Vaccines are the most effective way to protect a population against a disease, but the only TB jab on the market at present works solely in childhood, and does not work against all forms of the illness. The Bacille-Calmette Guérin (BCG) vaccine is routinely given to young babies around the world. It contains a live, but weakened, form of Mycobacterium bovis, a strain of TB originally isolated from cows.
It gives babies and young children protection against meningitis, and "disseminated" TB, which affects organs such as the stomach or bones, but the vaccine does not protect people against TB of the lungs, which is the most common form in adults.
Scientists from the University of Cape Town's Lung Institute and the South African Tuberculosis Vaccine Institute are planning to start immunising volunteers in the next few weeks. The Aeras-402/Crucell Ad35 candidate vaccine, which has already been shown to be safe in a smaller phase 1 trial in healthy adults in the US, will be given to 82 adults who have recently had TB, or are being treated for the disease.
Aeras and Crucell have also launched a phase 1 clinical trial in Kenya to test the safety of the vaccine in healthy adults, all of whom had the BCG vaccine and some of whom have previously had TB.
"There are many potential uses for a new TB vaccine. Therefore, it is important to determine a candidate's safety and immune responses in those who have already been exposed or have had active TB disease," said Aeras president and CEO Jerald Sadoff.
Cape Town had been chosen as a trial site because it had a high TB burden and good research infrastructure, said Aeras clinical project physician Sean Bennett.
TB is the world's second-deadliest infectious disease, and is the leading cause of death for people infected with HIV. More than 9-million new cases were diagnosed in 2006, and 1,7-million people died from the disease. More than 337000 new cases were diagnosed in SA in 2005, the most recent year for which figures are available, an 8% increase on the previous year.
The recent global surge in TB has led to fresh efforts to find new vaccines, tests and drugs. Last week, the Global Alliance for TB Drug Development and pharmaceutical firm Sanofi-Aventis announced that they had entered into a collaborative agreement to speed up TB drug development. Sanofi-Aventis developed rifampicin, the backbone of TB treatment in the early 1960s, and markets several other TB drugs.
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