Malawi is among seven countries expected to participate in a large clinical trial of a tuberculosis (TB) vaccine candidate to evaluate if it can protect adolescents and adults from pulmonary TB.
The Bill & Melinda Gates Medical Research Institute (Gates MRI) on Tuesday announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E TB vaccine candidate is now underway.
First doses have been given in South Africa, where TB takes a heavy toll.
If shown to be well-tolerated and effective, the vaccine could potentially become the first one to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century.
“At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam.
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“Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo,” a statement by Gates MRI says.
It adds that the approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.
The statement quotes Gates MRI Chief Executive Officer Emilio Emini as having said the launch of the trial demonstrates the institute’s commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries.
“Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine’s potential,” Emini said.
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Alemnew Dagnew, who leads development of the vaccine at the Gates MRI, said if effective, M72/AS01E, which has been in development since the early 2000s, could reinvigorate a global fight against TB that has been weakened by the Covid pandemic.
Phase 1 trials test if a new treatment is safe and look for the best way to give the treatment.
Phase 2 trials test if one type of a condition responds to the new treatment while phase 3 trials test if a new treatment is better than a standard treatment.
The Gates MRI, a non-profit organisation and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the M72/AS01E vaccine candidate trial.
The statement by the institute says while TB is one of the world’s deadliest infectious diseases, and the leading cause of death amongst people living with HIV, the only available TB vaccine, BCG, dates back to 1921.
“It 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,” it says.
Globally, according to the World Health Organisation, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died.
The National TB and Leprosy Elimination Programme has disclosed that in 2022, at least 17,000 people were diagnosed with TB while in 2023, there was an increase to 19,000 people in Malawi.
Meanwhile, the Ministry of Health has bemoaned misconceptions and stigma surrounding TB in the country.
In a statement issued ahead of the World TB Day, which falls on March 22, the ministry says with only six years left before 2030, when the country is expected to have eliminated the disease, Malawi is intensifying its response activities.
“Government is ensuring hospitals have enough workers, TB drugs and other supplies to reduce TB-related deaths,” the ministry says.
