Kenyans are among trial participants for the Phase III clinical trial of a tuberculosis (TB) vaccine candidate, M72/AS01E (M72), backed by the Wellcome and the Gates Foundation, to the tune of Ksh89 billion.
In a formal statement issued on Wednesday, July 30, GlaxoSmithKline (GSK) announced that it had completed the enrolment of 20,000 trial vaccine participants from various nations, including Kenya.
''The phase III clinical trial of M72/AS01E, a tuberculosis (TB) vaccine candidate originally developed by GSK and sponsored by Gates Medical Research Institute with funding support from the Gates Foundation and Wellcome, has completed full enrollment of 20,000 participants, 11 months ahead of schedule,'' the press statement read in part.
''The trial is taking place at 54 sites across South Africa, Kenya, Malawi, Zambia, and Indonesia,'' the statement continued.
If successful, M72 might be the first new TB vaccine in more than a century to meet the WHO's target product profile, according to GSK. The disease claims over 18,000 Kenyans every year, according to the Ministry of Health, and the vaccine could provide needed cushion for many.
The trial, estimated to cost Ksh89 billion (US$550 million), is an amount co-shared by the Gates Foundation and Wellcome. Wellcome is committing up to Ksh24.3 billion (US$150 million), while the Gates Foundation will provide the remaining Ksh64.7 billion (US$400 million).
“TB remains one of the world’s deadliest infectious diseases. The development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB,'' Julia Gillard, chair of the Board of Governors at Wellcome, said.
According to GSK, the World Health Organisation (WHO) estimates that a TB vaccine with 50 per cent efficacy in adolescents and adults could prevent up to 76 million new TB cases and 8.5 million deaths by 2050.
The only TB vaccine in use today, bacille Calmette-Guérin (BCG), helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB among adolescents and adults.
GSK’s M72/AS01E vaccine candidate showed promising results in earlier Phase IIb trials, with 50 per cent efficacy in preventing active TB in infected individuals.
The current Phase III trial aims to confirm these findings at a larger scale and across multiple geographies.
Kenya has a strong track record in vaccine research and clinical trials as it seeks to help scientists find solutions to the many diseases facing humankind.
