By Gift Briton

There is hope in the fight against Tuberculosis (TB) following the launch of Phase 3 clinical trials of a new vaccine candidate that could prevent pulmonary TB in adolescents and adults.

Bill and Melinda Gates Medical Research Institute (Gates MRI), which sponsors the clinical trial, announced the launch, noting that the Phase 3 clinical trial will assess the efficacy of the new TB vaccine candidate named M72/AS01E.

“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,” Dr Emilio Emini, CEO of the Gates MRI said, noting that although the clinical study may take several years, there hope in the vaccine’s potential.

According to the World Health Organization (WHO) estimates, approximately 3,500 people die of TB every day across the world. Further, more than 10 million people globally fell ill with TB in 2022.

If proven effective, the M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years.

The only available TB vaccine is Bacillus Calmette-Guerin (BCG) which dates back to 1921. It protects babies and young children against severe forms of TB but offers inadequate protection for adolescents and adults against pulmonary TB, which is primarily responsible for the transmission of the TB bacterium.

“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, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, South Africa, and national principal investigator for the trial in South Africa.

The first doses of M72/AS01E were given in South Africa, where TB takes a heavy toll, with the University of Witwatersrand in South Africa being the first of up to 60 sites in seven countries that will participate in the trials, including Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam.

Up to 20,000 people will participate in the trial, including people living with HIV. The 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 the vaccine or placebo.

The approach, according to the experts, is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.

The investigators anticipate that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities.

Recognizing the health and socioeconomic impacts of TB, Alemnew Dagnew, who leads the development of M72/AS01E at the Gates MRI notes that TB primarily affects people during their prime working years, leaving families without income and children without parents.

“M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic. I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities -and a vaccine that could help prevent that from happening would be transformative.”

The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI).

In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post-licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response.

Gates MRI, GSK, Wellcome and the Gates Foundation are collaborating to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful. The collaboration involves supporting research and building an evidence base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine.

“After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners’ expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world,” said Deborah Waterhouse, President, Global Health at GSK.

Alex Pym, Director of Infectious Disease at Wellcome, said: “While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be a success.”