Kenya has launched the third phase of a clinical trial for the M72/AS01E tuberculosis (TB) vaccine candidate, becoming the second African nation to undertake this initiative after South Africa. This trial, which began earlier this month, aims to assess the efficacy and safety of a vaccine that could potentially prevent pulmonary TB in adolescents and adults—the most prevalent form of the disease.
The Phase 3 clinical trial, announced by the Bill & Melinda Gates Medical Research Institute (Gates MRI) in March, commenced with the enrollment of participants on July 12 in various locations across Kenya, including Kisumu, Kilifi, Machakos, and Nairobi. The Kenya Medical Research Institute (Kemri) is leading the trial, with Dr. Videlis Nduba, Senior Principal Clinical Research Scientist, serving as the national principal investigator.
“Launching this Phase 3 trial for a TB vaccine candidate in Kenya is a major step, and we are delighted to be part of the global team driving this program,” Dr. Nduba stated. He expressed optimism about the progress and the potential impact of the vaccine in combating TB, a leading cause of death worldwide.
The trial is being conducted at nine sites across Kenya and aims to enrol up to 20,000 participants, including people living with HIV. Participants will receive either the investigational M72/AS01E vaccine or a placebo in a double-blind setup, ensuring that neither the participants nor the clinical investigators know who receives the actual vaccine. This method is considered the gold standard for evaluating the efficacy and safety of new vaccines.
Following the initial rollout in South Africa, where the first doses were administered in March, the study will expand to include up to 60 trial sites across seven countries: South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam.
The World Health Organization reports that TB remains a significant global health issue, with an estimated 10.6 million people contracting the disease in 2022 and 1.3 million succumbing to it. The burden of TB is particularly high in low- and middle-income countries, where the disease is often exacerbated by poverty, poor living conditions, and undernutrition.
Evaline Kibuchi, Chief National Coordinator of the Stop TB Partnership Kenya, expressed excitement over the potential of the M72/AS01E vaccine, noting that it could be a critical tool in the fight against TB. "For a long time, TB advocates have pushed for prevention as a key strategy to end TB, and while public health interventions have been important, a vaccine is the ultimate solution," she said.
The outcomes of the Phase 3 trial are eagerly anticipated, as they could pave the way for the first new TB vaccine in over a century, offering hope for a significant reduction in TB cases and deaths worldwide.
Article by Nyokabi Wanjiku
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