Kenya has joined South Africa and Tanzania in a groundbreaking large-scale clinical trial aimed at testing the effectiveness of a new tuberculosis (TB) vaccine, MTBVAC. This trial, led by the global research organization IAVI and Spanish biotech firm Biofabri, represents a significant step toward finding a more effective vaccine for TB, particularly for adolescents and adults with latent TB infections.
The study, named IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunisation for a Neglected Epidemic), is a phase 2b clinical trial that will enroll 4,300 participants across 15 sites in Kenya, South Africa, and Tanzania. The goal of the trial is to evaluate the safety and efficacy of the MTBVAC vaccine, which has already shown promising immune responses in early studies.
In Kenya, the research will be conducted at the Kenya Medical Research Institute (KEMRI)/Centre for Respiratory Disease Research in Nairobi and the Victoria Biomedical Research Institute in Kisumu. These institutions will play a crucial role in assessing how the vaccine performs in local populations.
According to a statement released by IAVI on Thursday, “MTBVAC is a promising vaccine candidate being evaluated in the IMAGINE trial, a large-scale safety and efficacy trial evaluating the prevention of TB disease in adolescents and adults with latent TB infection.”
Tuberculosis remains one of the most deadly infectious diseases globally. The World Health Organization (WHO) estimates that in 2023, approximately 10.8 million people developed TB, with men making up the majority of cases (6 million), followed by 3.6 million women and 1.3 million children.
In Kenya, the 2022 Kenya Demographic Health Survey (KDHS) found that 1.1% of the population is currently living with TB. Additionally, a significant number of individuals carry latent TB infections, meaning they have the bacteria but do not exhibit symptoms or spread the disease. WHO further estimates that a quarter of the global population has been infected with TB bacteria, with 5-10% eventually developing symptoms.
Currently, the only available TB vaccine is Bacillus Calmette-Guérin (BCG), which provides some protection to children but does not effectively prevent TB in adolescents and adults. This limitation has intensified efforts to develop a more effective vaccine that can reduce TB cases across all age groups.
Dr. Lewis Schrager, who leads IAVI’s TB vaccine development program, emphasized the importance of this new vaccine trial, stating, “The IMAGINE trial is an important new effort to develop a vaccine capable of combating the world’s deadliest disease.”
While Kenya is playing a critical role in the new vaccine trial, the country is also facing an urgent shortage of the BCG vaccine, putting infants at risk of contracting TB.
The Kenya Pediatric Association has urged the government to act swiftly to address the crisis, as TB remains a significant health threat to children. In response, Kenya’s Health Director-General, Dr. Patrick Amoth, announced that 2.34 million BCG vaccine doses are expected to arrive before the end of January. This move aims to fill the vaccine gap and protect newborns from TB infection.
The development of an effective TB vaccine for adolescents and adults is critical in reducing the global TB burden. If successful, MTBVAC could provide long-term immunity and prevent millions of TB-related deaths worldwide.
IAVI noted that early trials of MTBVAC have shown strong immune responses and a safety profile comparable to the BCG vaccine. If the IMAGINE trial confirms its effectiveness, MTBVAC could become a game-changer in global TB prevention efforts.
With Kenya, South Africa, and Tanzania participating in this historic trial, the results could mark a major breakthrough in global TB control and save millions of lives in the coming years.
