First participants for TB vaccine trial

THE Africa Health Research Institute (AHRI) in Mtubatuba last week screened the first eight participants to be enrolled in its M72 TB vaccine phase 3 clinical trial.

This as World TB Day was commemorated on Sunday, 24 March.

The institute said it aims to enrol 1 000 participants over the next year, targeting multiple areas in northern KZN where it is known there is a high rate of new TB infections.

The institute said M72 could be a game-changer for TB control globally and if the trial shows the vaccine is well-tolerated and effective, it would be the first vaccine to help prevent TB in adolescents and adults, and the first new TB vaccine in over 100 years.

AHRI said the trial will ultimately enrol up to 20 000 participants at around 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam.

“This is critical work. It is clear from modelling studies that if we do not have an effective vaccine that prevents TB in adolescents and adults – as BCG does in babies – we will not control the TB epidemic,” said AHRI executive director Prof Willem Hanekom.

Hanekom is the co-national principal investigator, together with Professor Lee Fairlie from Wits RHI, for the trial in South Africa.

During a media tour last year, Hanekom told journalists that the M72 has shown early efficacy, having shown to be safe, and in early trials, having shown a 50% effectiveness.

Hanekom said at the time that phase 3 of the trials would be a 'definitive assessment' of the vaccine.

He explained that the trial would take about six years, with preliminary results expected around 2028.

He also said that since, in South Africa, about 70% of people with TB live with HIV, ultimately this segment of people would be included in the trials.