University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI) and Stellenbosch's Desmond Tutu TB Centre are recruiting infants to test a new tuberculosis vaccine for newborns of HIV-positive moms, a demographic not served by the current vaccine.
Oxford-Emergent Tuberculosis Consortium, a joint venture between Emergent BioSolutions ($EBS) and Oxford University, developed the MVA85A vaccine, which has been successfully tested for safety in healthy adults, children and HIV-positive adults. Researchers plan to enroll 340 newborn infants of HIV-positive mothers at clinics in two South African cities. Half will receive MVA85A at birth and the other half a placebo. Those born without HIV will also receive the Bacillus Calmette-Guerin vaccine, the current TB shot on the market, two months later.
"If this MVA85A vaccine study is successful, it will benefit in particular those babies at risk of HIV infection, who are also at high risk of getting TB," Mark Hatherill, UCT's associate professor who is leading the study, said in a statement.
The BCG vaccine works in most healthy children, but can lead to complications in HIV-infected babies. And the current TB vaccine does not protect against lung TB, the most common form of the disease. Last year, 8.7 million people fell ill with TB and 1.4 million died from the disease, according to the World Health Organization. More than 95% of those deaths occur in low- and middle-income countries.
TB also causes one-quarter of all deaths of those living with HIV. People with compromised immune systems--those with HIV, among other diseases--have a much higher risk of falling ill. To put that in perspective, people who are co-infected with HIV and TB are 21 to 34 times more likely to become ill with TB. And last year, sub-Saharan Africa reported the greatest proportion of new cases per population, counting 260 cases per 100,000 people.
Organon Teknika manufactures the two BCG vaccines licensed in the U.S. But biotechs have been, for some time, searching for a new, more effective TB vaccine than the 90-year-old BCG used commonly today.
The Wellcome Trust, the Medical Research Council in the U.K. and the U.K.'s Department of International Development are the main funders behind SATVI's study.
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