SAMRC contributes to enrolment completion in the Gates MRI TBV02-301 TB Prevention study

The Gates MRI announced that the M72 Phase 3 trial enrolment target of approximately 20000 participants has been reached eleven months ahead of schedule.

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. The early enrolment completion is an indicator of the level of support, partnerships and excitement from the trial site communities and study volunteers in this potentially historic vaccine candidate. We celebrate this milestone with the global community stakeholders, study volunteers, sponsors, and research teams.

As the TB burden continues to rise in the face of resource constraints, there is an urgent need for a TB preventative vaccine that can help protect adolescents and adults from the disease. If proven to be efficacious and well tolerated, the vaccine candidate could be the first new TB preventative vaccine in 100 years.

Study background: The M72 vaccine trial is a phase 3, randomized, double-blind, multicentre trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.

The study enrolled the 20081 volunteers across 54 trial sites in five countries with two sites from the SAMRC HIV and other Infectious Diseases Research Unit, in Durban. The Botha’s Hill Clinical Research Site and the Phoenix Clinical Research site screened a combined total of 1370 participants and enrolled 542 eligible participants. The study follow up is expected to continue for another 2-3 years.

The CEO of Gates MRI, Patrice Matchaba, said:

“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. If proven as well tolerated and efficacious, it could be the first new TB vaccine in 100 years.”

The community liaison officer of the Phoenix CRS, Lungisani Ngodwana, said: “I have seen first-hand the impact of TB on our communities. The vaccine may be a potentially powerful tool in our fight against this disease.”

The PI of the Phoenix CRS, Dr Saresha Pillay, said: “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.”

The community liaison officer of the Botha’s Hill CRS, Clifford Gcwensa, said: “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. At the Botha’s Hill site, we resolved to always work through our peer education program and our community advisory board to intensify our recruitment. As a leading organization in the research sector in Kwazulu-Natal province, we then took a stand to contribute and ensure that our province plays a leading role in research when it comes to TB/HIV and other infectious diseases. This was the driving force behind the 55.2% that was contributed to the enrolment target.”