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Next phase of TB vaccine clinical trial sparks hope of game-changing results – top SA scientist

Next phase of TB vaccine clinical trial sparks hope of game-changing results – top SA scientist
The experimental vaccine M72/AS01E will be administered as two intramuscular injections given a month apart. (Photo: Mathurin Napoly / Matnapo on Unsplash)

If successful, the candidate vaccine will provide the first TB vaccine for adults with latent TB, as the only other vaccine available is the BCG vaccine that is given to infants to prevent TB.

The next phase of a clinical trial to assess the efficacy of the first tuberculosis (TB) vaccine for adults started in South Africa this month and the head of global health at the Bill & Melinda Gates Foundation, Dr Trevor Mundel, said he was hopeful that the vaccine would be a game-changer.

Mundel was born and raised in South Africa, and obtained his medical and other degrees at Wits University. He studied mathematics, logic and philosophy as a Rhodes Scholar at Oxford University, and earned a PhD in mathematics at the University of Chicago.

Mundel said that when considering lessons from the Covid-19 pandemic, one had to look at the speed with which vaccines were developed and deployed.

“You have to ask, why we do not have the same urgency when it comes to TB? It is a valid question. We haven’t seen enough progress,” he said. “We won’t meet the 2030 objective the World Health Organization set [to end the TB pandemic].”  

Read more in Daily Maverick: Massive TB vaccine trial starts in SA – could deliver first new jab in over a century

Mundel said a lot of effort had to go into dispelling fake and misleading information about vaccines in South Africa.

Trevor Mundel

The head of global health at the Bill & Melinda Gates Foundation, Dr Trevor Mundel. (Photo: Supplied)

“I have spoken to the community advisory board for this study, and it is interesting that, unlike with Covid-19, community members know people who died of TB. The uptake of the Covid-19 vaccine also helped because many people said they could see people who had received the Covid-19 vaccine did not develop any major side effects,” he said. 

Mundel said TB diagnostics in South Africa needed to be strengthened. There have been new developments in TB diagnostics technology, including handheld X-ray devices that can take and interpret a chest X-ray with artificial intelligence.

“It would take one minute,” he said.

In Johannesburg, a mass PCR test for TB is already available, which allows between 3,000 and 5,000 TB tests to be done at the same time for under $1.

“So, we will be able to do mass screenings for TB at a much lower cost,” he said. 

Read more in Daily Maverick: Yes we can eliminate tuberculosis, but it will need a mass screening campaign

When it came to the new vaccine, “South Africa had the largest target population for this trial,” he said. “It has a high burden of latent TB infections.” 

Importance of nutrition

This was caused by HIV and a host of other smaller factors, but undernutrition was a major contributor. 

“Proper nutrition plays a major role in preventing TB,” Mundel said.

He referred to a recent study in India, in which nutritional intervention was found to substantially reduce (by 39%–48%) the incidence of TB in households.  

He believes that in the next decade, there will be significant leaps in the fight against TB, including the introduction of new drugs and a vaccine. 

Read more in Daily Maverick: New TB drug shows promise, but experimental vaccine disappoints

Last week, the Bill & Melinda Gates Medical Research Institute (Gates MRI) announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate was under way, with the first doses given in South Africa.

“If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine 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.”

Mundel said the vaccine aimed to prevent patients with latent TB from developing the disease and suffering damage to their lungs as a result.    

In South Africa alone, about 280,000 people are diagnosed with TB each year.   

“The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Emilio Emini, the CEO of the Gates MRI.

“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.”  

The Gates MRI, a nonprofit organisation and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. 

“Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities,” said Dr Lee Fairlie, the director of Maternal and Child Health at Wits RHI at Wits University. 

“South Africa also has considerable experience with TB — and vaccine-related clinical trials, and a strong track record for protecting patient safety and generating high-quality data essential for regulatory approvals.”   

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. DM

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