In a groundbreaking move to combat tuberculosis (TB), the Bill & Melinda Gates Medical Research Institute (Gates MRI) has announced the initiation of a Phase 3 trial for a promising TB vaccine candidate in South Africa. The vaccine, known as M72/AS01E, holds the potential to be a game-changer in the prevention of pulmonary TB in adolescents and adults, representing a significant advancement in TB vaccine development.

Sponsored by Gates MRI with funding support from the Wellcome Trust and the Bill and Melinda Gates Foundation, this Phase 3 trial reflects a collaborative effort to address TB, which remains a pressing health concern in low- and middle-income countries.

Originally developed and evaluated by biopharmaceutical company GSK up to Phase 2b, the M72/AS01E vaccine entered a partnership with Gates MRI in 2020 for further development. GSK is lending technical expertise and supplying the adjuvant component for the Phase 3 trial, with commitments for post-licensure support in the event of trial success. Adjuvants play a crucial role in vaccines by enhancing immune response.

Dr Emilio Emini, CEO of Gates MRI, stressed the importance of medical innovation in combating diseases like TB, highlighting the collaborative efforts of global partners. While the Phase 3 trial requires years for clinical study, it represents a beacon of hope in the fight against TB.

South Africa has been selected as a pivotal location for the trial due to its extensive experience in TB-related clinical trials and its track record in ensuring patient safety and generating high-quality data for regulatory approvals. Dr. Lee Fairlie, the national principal investigator for the trial in South Africa, emphasized both local and global commitments to combat TB, a disease that continues to affect communities worldwide.

The trial aims to enrol up to 20,000 participants across approximately 60 trial sites in South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. Notably, the inclusion of individuals living with HIV reflects the comprehensive approach to addressing TB, particularly in populations with heightened vulnerability.

If successful, the M72/AS01E vaccine would represent a breakthrough as the first licensed TB vaccine since the introduction of the bacilli Calmette-Guerin (BCG) vaccine in 1921. While BCG has demonstrated effectiveness in preventing severe forms of TB in young children, its efficacy in adults and adolescents remains limited.

 

Article by RB Reporter

Photo/Google

https://www.gatesmri.org/mri-initiates-phase-3-clinical-trial-tuberculosis-vaccine-candidate/