By Muhammad Amaan
The Bill & Melinda Gates Medical Research Institute has announced the commencement of a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis vaccine candidate with the first doses to be 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 vaccine to help prevent pulmonary TB in adolescents and adults and become the first new TB vaccine in over a century.
The Bill & Melinda Gates Medical Research Institute is a non-profit dedicated to developing and deploying new biomedical interventions for global health challenges including malaria, tuberculosis, and maternal and child health issues.
According to the World Health Organisation, about 10.6 million people had TB in 2022 and 1.3 million died, globally.
This implies that over 3,500 people died per day of the disease.
The WHO Global TB Report 2021 states that Nigeria has the highest number of TB cases in Africa and accounts for 4.6 per cent of the global TB burden.
TB is an infectious disease caused by a bacterium called Mycobacterium tuberculosis. It affects the lungs and other parts of the body and it is transmitted when an infected person coughs or sneezes.
TB is predominant in low and middle-income countries, and those at the highest risk are often steep in poverty, with poor living and working conditions, and suffer from undernutrition.
Ahead of World Tuberculosis Day on March 24, a representative of the WHO, Dr Amos Omoniyi, called for more funding to tackle the disease burden in Nigeria.
In a statement, the CEO of the Gates MRI, Emilio Emini, said that the launch of the trial was a demonstration of harnessing the power of medical innovation to fight diseases like TB.
Emini added, “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 M72/AS01E vaccine candidate has been in development since the early 2000s.
The statement further reads, “It was originally designed and clinically evaluated by the biopharma company GlaxoSmithKline up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation.
“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.”
The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3.
It added that the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access when the trial is successful.
Director of Maternal and Child Health at Wits RHI, University of the Witwatersrand, Johannesburg, South Africa, and National Principal Investigator for the trial in South Africa, Dr Lee Fairlie, also said, “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.
“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.”
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.
The statement further noted that 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.
This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.
