Major Medical Charities Finance Large-Scale Clinical Trial of New TB Vaccine: M72

Two major medical charities will contribute about 550 million dollars (505 million euros) to finance a large-scale clinical trial of what would be the first new TB vaccine in more than a century.

The vaccine, called M72will be administered from next year to 26,000 young adults in Africa and Southeast Asia who have a latent infection with the bacterium that causes tuberculosis but do not have symptoms. The Bill and Melinda Gates Foundation will contribute $400 million to the phase 3 trialwhile Wellcome Trust will contribute 150 million.

most years, tuberculosis kills more people than any other infectious disease: It is estimated that in 2021 it caused 1.6 million deaths. Cases increased during the coronavirus pandemic, and the World Health Organization warned last year of the spread of drug resistant strains.

According to Trevor Mundel, head of global health at the Gates Foundation, the trial will take several years to provide clear evidence on the efficacy of M72 to prevent the occurrence of active pulmonary tuberculosis. A smaller phase 2 study with 3,500 people in southern Africa reported in 2018 that the M72 had an efficiency of 54%.

The WHO estimates that a vaccine with 50% efficacy in preventing the onset of active disease could save between 4.6 and 8.5 million lives in 2050.

“Of course, we would be happy with 90% efficiency, but according to our models, 50% is enoughassuming that the durability is at least five years, and most vaccinologists who have analyzed the data have said that it is likely,” says Mundel.

Corixa, a US biotech company acquired the following year by GSK, first tested a prototype M72 vaccine in humans in 2004. The British pharmaceutical group further developed M72, with funding from various aid agencies, before granting the Gates Foundation a non-exclusive license to market it in a hundred low- and middle-income countries.

GSK will continue to provide its AS01E adjuvant, which enhances the vaccine stimulating the recipient’s immune system. The other critical ingredient of the M72 is a “fusion protein” derived from the tuberculosis bacterium.

Alexander Pym, Wellcome’s head of infectious diseases, explained that it had taken so long to get M72 into a large-scale clinical trial in part because the complex life cycle of the pathogen, which remains dormant in the patient for years before symptoms appearmade it a difficult target for vaccine development, and in part because of “market failure.”

“Tuberculosis is the disease of poverty par excellence”says Mundel. “Its incidence is closely related to poverty worldwide. The reality is that there is no commercial market for TB drugs, diagnostics or vaccines.”

Thomas Breuer, GSK’s head of global health, agrees. His team runs the largest R&D program aimed at combating infectious diseases in the developing world, “but at the end of the day we are not an NGO. We are a listed company,” he says, explaining the decision not to carry the vaccine beyond phase 2 trials as a corporate project.

Community groups and activists welcomed the investment in the Phase 3 trial. Mark Harrington, CEO of Treatment Action Group, states: “We hope this funding commitment will encourage governments and other funders to substantially increase investments in the portfolio of tuberculosis vaccines, which contains a number of promising candidates in addition to M72, but which is facing a serious financial shortfall.

The only vaccine against tuberculosis currently available is BCG or Bacillus Calmette-Guérin, developed in France at the beginning of the 20th century. by Albert Calmette and Camille Guérin from a weakened strain of bovine tuberculosis. It protects infants against severe systemic disease but offers little protection against pulmonary tuberculosis in adolescents and adults.

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2023-06-29 16:31:17
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