Zambia has launched phase 3 clinical trial for TB vaccine
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Loading... - CHARLES BIIRA
- 19 Sep 2024
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Zambia has launched a phase 3 clinical trial for a promising tuberculosis (TB), marking a significant step in the country’s efforts to combat the disease. The first trial site is in Lusaka, where screening of participants began on August 29. There will be four clinical trial sites in total across Zambia. The country joins Kenya and South Africa, which started phase 3 trials earlier this year.
TB remains a major public health issue in Zambia, affecting around 59,000 people annually, particularly those living in poverty with limited access to healthcare. An effective vaccine is seen as critical, especially for adolescents and adults who are most at risk of contracting pulmonary TB, the most common and transmissible form of the disease.
Dr. Monde Muyoyeta, the national principal investigator from the Centre for Infectious Diseases Research in Zambia (CIDRZ), expressed optimism about the trial's potential to confirm the positive results seen in phase 2 trials. The phase 3 trial, which involves up to 20,000 participants across seven countries, is double-blind, meaning neither participants nor investigators will know who receives the vaccine or a placebo.
The vaccine, M72/AS01E, if proven effective, could become the first new TB vaccine for adults and adolescents in over 100 years. It will take up to five years to complete the trial, after which the data will be analyzed and submitted to regulatory authorities.
Globally, TB remains one of the deadliest infectious diseases, particularly affecting people in low- and middle-income countries. In 2022, 10.6 million people contracted TB, and 1.3 million died. The Bacillus Calmette–Guérin (BCG) vaccine, developed in 1921, is the only available TB vaccine but is mainly effective in young children and offers limited protection for adults and adolescents against pulmonary TB.
The trial is sponsored by the Gates MRI, a nonprofit subsidiary of the Bill & Melinda Gates Foundation, with support from the Gates Foundation and Wellcome. If successful, this vaccine could be a major breakthrough in the global fight against TB.
