Kenyans receive the first TB vaccine in 100 years

The first group of Kenyans has received what is likely to be the first TB vaccine in about 100 years.

The first doses were given on July 22 in Kisumu, Kilifi, Machakos and Nairobi.

However, it is still under trial and may not be widely available to the public before 2030.

It is administered as two intramuscular injections given a month apart.

Currently, the only TB vaccine available is BCG for children developed in 1921.

BCG protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium.

Kenya Medical Research Institute is leading the trial for the new vaccine in Kenya, currently in Phase 3, almost the last stage before consideration for adoption.

The new vaccine is for adults and will be trialed in nine clinical sites.

“Launching 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 that helps drive this programme,” said Dr Videlis Nduba, Senior Research Scientist at Kemri and the national principal investigator for the trial in Kenya.

“Unfortunately, TB is a disease that remains present in our communities and we have a strong commitment to play our part in addressing this public health challenge.”

The vaccine candidate is called M72/AS01E  and has been in development since the early 2000s.

It was originally designed and clinically evaluated by the GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative and was funded by GSK and in part by the Bill & Melinda Gates Foundation.

In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E.

“The M72 is a vaccine that helps to prevent TB infected individuals from progressing to active infection. Prior phase 2 clinical trial results indicated the vaccine is promising,” Kemri said.

In GSK’s Phase 2b trial, M72/AS01E provided approximately 50 per cent protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in TB-infected HIV-negative adults. The developers said this was unprecedented in decades of TB vaccine research.

The World Health Organization estimates that over a 25-year period, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion (Sh5.3 trillion) for TB affected households.

In Kenya alone, around 128,000 people are diagnosed with TB every year.

The current trial is sponsored by the Gates MRI, a nonprofit organisation and subsidiary of the Bill & Melinda Gates Foundation. The Gates Foundation and Wellcome came together to fund the trial through the Gates MRI. 

At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in Kenya, South Africa, Zambia, Malawi, Mozambique, Indonesia and Vietnam.

The first doses were given in South Africa in March, where TB takes a heavy toll.

The investigators expect the trial to take at least five years to complete.

“We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB," said Trevor Mundel, president, Global Health, Bill & Melinda Gates Foundation.

"The start of the Gates MRI’s M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world’s most vulnerable communities.”