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Kenya to play part in race for TB vaccine upgrade

TB vaccine

IAVI says that a TB vaccine that is effective in children, adolescents and adults would save millions of lives.

Photo credit: Shutterstock

Kenya is among three countries taking part in a major tuberculosis (TB) vaccine trial that will upgrade a vaccine that has been in existence for almost a century.

In the country, trials will be conducted by scientists from the Kenya Medical Research Institute (Kemri) and the Centre for Respiratory Disease Research in Nairobi.

The trials will be conducted in 15 sites in South Africa, Kenya and Tanzania.

The Bacillus Calmette-Guérin (BCG) vaccine is the only approved vaccine against TB and was introduced more than 100 years ago.

The BCG vaccine provides partial protection in children, but does not prevent TB disease in adolescents or adults.

In a clinical trial conducted by the Spanish biopharmaceutical company Biofabri and non-profit scientific research organization IAVI, about 4,300 vaccine participants from 15 cites globally received their first doses on February 19, 2025.

The new MTBVAC vaccine was administered in the IMAGINE (Investigation of MTBVAC toward Accelerating Global Immunization for a Neglected Epidemic) clinical trial.

IAVI says that a TB vaccine that is effective in children, adolescents and adults would save millions of lives.

The vaccine was developed by Spanish researchers Carlos Martin of the University of Zaragoza and Dr Brigitte Gicquel of the Institut Pasteur. It was produced and licensed by Biofabri.

It is currently given as a single dose, with participants receiving a shallow injection, usually in the forearm, and then being followed for about two to three years.

The clinical trials are being conducted to help scientists understand the safety and efficacy of the vaccine to prevent active TB lung disease in adolescents and adults.

“A new and efficacious vaccine against TB, the world’s deadliest infectious disease, would have tremendous public health impact. This trial represents a very important milestone in global efforts to mitigate the terrible impact of the TB pandemic, and we are very grateful for the support of our funders and partners, and, importantly, the study volunteers who will participate in the IMAGINE trial,” said IAVI chief executive Dr Mark Feinberg.

In a press release, IAVI said that the new vaccine is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current trials.

“This is a notable difference from BCG, which is derived from Mycobacterium bovis, the bovine form of tuberculosis,” explains IAVI.

So far, the vaccine has been tested in two Phase 2 clinical trials in adults and children under the age of 28.

“It was shown to have either comparable or favourable immunogenicity and safety profiles at different doses as compared to BCG,” said the scientists.

Dr Lewis Schrager, head of IAVI’s TB vaccine development efforts, said that the ongoing clinical trial is an important new effort to develop a vaccine capable of combating the world’s deadliest disease.

“Because MTBVAC is a single-shot vaccine we are hopeful that, if proven effective, MTBVAC could prevent millions of cases of TB disease, particularly in persons living in some of the world’s most difficult-to-reach locations,” he said.

Prof Keertan Dheda of the University of Cape Town, who is also the main investigator of the IMAGINE clinical trial, reiterated the urgent need for an improved TB vaccine upgrade.

“Besides the millions of resultant deaths, TB is also associated with substantial reductions in the gross domestic product of low- and middle-income countries, given that economically active young people are often affected by the disease,” he said

“Even after effective treatment patients often suffer lung damage and scarring, and thus TB is the most common and important cause of lung disability in many TB endemic countries. Drug-resistant TB is an emerging threat to TB control that is difficult and more expensive to treat,” he added.

The study is sponsored by IAVI and funded by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank.