Clinical trials to test a new tuberculosis (TB) booster injection are about to begin in rural South Africa. The trials are unusual in that the test subjects will be infants.
Researchers from the South African Tuberculosis Vaccine Initiative (SATVI) hope to prove the new vaccine can increase the effectiveness of the Bacille Calmette-Guerin (BCG) vaccine, which has been used for nearly 90 years, according to PlusNews.
The traditional BCG vaccine does not provide protection against the most common form of TB, which attacks the lungs. Close to 2,800 infants are to take part in the two-year test programme, which is being conducted jointly by SATVI and the University of Cape Town. The new vaccine is produced by Dutch biopharmaceutical company Crucell N.V.
TB often attacks HIV patients and has become more widespread in South Africa as a result of the AIDS epidemic here.
Co-director of Witwatersrand University’s Perinatal HIV Research Unit, Dr Glenda Grey, said the burden for ethical treatment was higher than otherwise in the case of children and babies:
Ethics committees must also ensure that infants don't find themselves in a more vulnerable position than they already are because they participated in a trial. You have to minimise the harm and maximize the benefits.
Concerns have been raised over the $19 fee given to the parents of the infants. The tests are to be carried out in one of South Africa’s poorest areas, around Worcester in the Eastern Cape.
TB has become a major medical problem in South Africa partly because of its appearance together with HIV, but also because rural patients tend not to complete their prescribed courses of medicines. Instead, once they feel better, they stop, often to find they have become victims of Multiple Drug Resistant (MDR) TB, which is very difficult to treat, let alone cure.