Kenya is among three African nations set to participate in a large-scale clinical trial aimed at testing a promising new tuberculosis (TB) vaccine. The trial, spearheaded by global research organization IAVI in partnership with Spanish biotech firm Biofabri, will evaluate the effectiveness of the MTBVAC vaccine in preventing TB among adolescents and adults with latent TB infections. This initiative represents a significant step in the global fight against TB, a disease that continues to claim millions of lives each year.
The clinical trial, named IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunisation for a Neglected Epidemic), is a phase 2b study expected to enroll 4,300 participants across 15 sites in Kenya, South Africa, and Tanzania. In Kenya, the trial will be conducted at the Kenya Medical Research Institute/Centre for Respiratory Disease Research in Nairobi and the Victoria Biomedical Research Institute in Kisumu. Researchers will assess the safety and efficacy of MTBVAC, which has shown promising results in earlier trials.
Tuberculosis remains one of the deadliest infectious diseases worldwide. The World Health Organization (WHO) estimates that in 2023, approximately 10.8 million people were diagnosed with TB, including 6 million men, 3.6 million women, and 1.3 million children. The disease spreads through airborne particles released when an infected person coughs, sneezes, or spits. In Kenya, the 2022 Kenya Demographic Health Survey (KDHS) found that around 1.1 percent of the population is currently living with TB. Many others carry latent TB infections, meaning they have the bacteria in their bodies but do not exhibit symptoms or spread the disease. WHO estimates that a quarter of the global population has been infected with TB bacteria, with 5-10 percent of them eventually developing active symptoms.
The only currently approved TB vaccine, the Bacillus Calmette-Guérin (BCG), provides some protection to children but has limited effectiveness in preventing TB in adolescents and adults. This limitation has spurred global efforts to develop a more effective vaccine that can offer protection to a broader age group. The MTBVAC vaccine, developed by Biofabri, has been undergoing trials for several years. It is the only TB vaccine candidate made from a live, attenuated form of Mycobacterium tuberculosis, the bacteria responsible for TB. Unlike the BCG vaccine, which is derived from a related bacterium, Mycobacterium bovis, MTBVAC has demonstrated a strong immune response in early trials and a safety profile comparable to BCG.
According to IAVI, an effective TB vaccine for children, adolescents, and adults could prevent millions of deaths worldwide. Lewis Schrager, head of IAVI’s TB vaccine development efforts, emphasized the urgency of the IMAGINE trial, stating that it represents a critical step toward addressing TB, which remains one of the world’s deadliest infectious diseases. With Africa bearing a significant burden of TB cases, the participation of Kenya, Tanzania, and South Africa in the trial highlights the region’s role in advancing global TB research and developing solutions to combat the disease.
If successful, the MTBVAC vaccine could significantly alter the trajectory of TB prevention efforts. It has the potential to reduce transmission rates, decrease TB-related deaths, and ultimately contribute to global efforts to eradicate the disease. The results of the IMAGINE trial will be closely monitored by researchers, policymakers, and healthcare professionals worldwide, as a breakthrough in TB vaccine development could lead to a major public health victory.
