Tuberculosis, caused by bacterium Mycobacterium tuberculosis, is one of the world’s deadliest diseases. Although the BCG, a 100-year-old vaccine, has played a key role, it has been only partially effective.
Now, a century later, two of the world’s wealthiest charities, the Bill & Melinda Gates Foundation and Wellcome, said they would fund a late-stage trial of a new TB vaccine known as m72. Reportedly, it will cost $550m, of which the Gates Foundation will contribute $400m.
If proven effective, M72 could potentially become the first new vaccine to help prevent pulmonary TB, a form of active TB, in more than 100 years.
“Despite being curable, TB remains one of the leading causes of death in South Africa. In the area where I live and work, more than half of all people have had, or will have, TB at some point in their lives. The consequences are devastating, both at a personal and a community level. M72 offers us new hope for a TB-free future,” said Nomathamsanqa Majozi, head of public engagement at Africa Health Research Institute in a statement.
The BCG vaccine helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults. Currently, it is the only TB vaccine.
gsk, a big pharmaceutical firm, acquired M72 from Corixa, an American company, in 2005. According to media reports, early trials reveal that it was about 50 percent effective in preventing tb in the lungs of those with a latent infection. Reportedly, no other vaccine has worked for this group.
“The Phase III clinical trial to assess the candidate vaccine’s efficacy at preventing progression from latent TB infection to pulmonary TB will be sponsored by the Bill & Melinda Gates Medical Research Institute (the Gates MRI), a nonprofit organization and subsidiary of the Gates Foundation dedicated to the development and effective use of novel biomedical interventions to address substantial global health concerns. Conducted in collaboration with an international consortium of TB clinical investigators, the trial will enroll approximately 26,000 people, including people living with HIV and without TB infection, at more than 50 trial sites in Africa and Southeast Asia,” the foundation said in a statement.
It also stated that additional details about the trial design and participants will be announced by the Gates MRI in the coming months. The Gates MRI is the license holder for M72 in low- and middle-income countries with high TB burden, it added.
Reportedly, this vaccine could save 8.5 million lives and prevent 76m cases of TB, over the next 25 years. The Phase III trial is set to begin early next year, and last between 4-6 years.
According to a report published in The Nature Journal, M72/AS01E consists of a fused protein called M72 — comprised of two M. tuberculosis antigens — and an adjuvant, AS01E.
Moreover, several companies are also working on developing TB vaccines, and a handful of other vaccine candidates are in phase III trials.
