Durban sites play pivotal role in global TB vaccine trial
Early enrolment completion in the global M72 Phase 3 TB vaccine trial marks a significant milestone, says the researchers.
Image: Henk Kruger/ Independent Newspapers
The Gates Medical Research Institute (Gates MRI) has announced the early completion of participant enrolment in the global M72 Phase 3 tuberculosis (TB) vaccine trial, eleven months ahead of schedule. A total of 20,081 participants were enrolled across 54 sites in five countries, including two South African sites operated by the South African Medical Research Council (SAMRC).
The Phoenix and Botha’s Hill Clinical Research Sites (CRS), both operated by the SAMRC HIV and Other Infectious Diseases Research Unit in Durban, played a key role by screening 1,370 participants and successfully enrolling 542 eligible volunteers.
“This marks a significant milestone in the pursuit of a safe and efficacious TB vaccine that may potentially bring us closer to addressing one of the world’s most urgent public health challenges,” Gates MRI said in a statement. “The early enrolment completion is an indicator of the level of support, partnerships, and excitement from the trial site communities and study volunteers.”
Gates MRI CEO Patrice Matchaba emphasised the urgent need for a preventative vaccine: “With the M72 trial at full enrolment, we take another step closer to the critically important goal of a safe and effective tuberculosis vaccine. A TB vaccine that can help protect adolescents and adults from the disease is urgently needed.”
“M72/AS01E is the only investigational TB vaccine for adolescents and adults, with clinical proof of concept for vaccine efficacy,” Matchaba added. “If proven as well tolerated and efficacious, it could be the first new TB vaccine in 100 years.”
At the Phoenix site, Community Liaison Officer Lungisani Ngodwana said: “I have seen firsthand the impact of TB on our communities. The vaccine may be a potentially powerful tool in our fight against this disease.”
Principal Investigator at the Phoenix site, Dr Saresha Pillay, described the trial as a pivotal moment in global health: “The M72 trial represents an important milestone in the global efforts to diminish the impact of the world’s deadliest infectious disease. I feel so privileged to be part of a dedicated team, and together we are a formidable force in the fight against TB.”
At the Botha’s Hill site, Community Liaison Officer Clifford Gcwensa highlighted the site’s contribution: “Today we celebrate more than just the completion of enrolment into this important trial, but we also honour the courage to begin and the commitment to continue, with the community that makes learning possible. This was the driving force behind the 55.2% that was contributed to the enrolment target.”