M 72/AS01E tuberculosis vaccine phase II b data show promise

October 29, 2019 0 By FM

The final analysis of phase IIb trial of the candidate tuberculosis vaccine M72/AS01E showed to significantly reduce the incidence of pulmonary tuberculosis disease (TB), reports GSK and IAVI.

The results from the trial has been published today (29th October, 2019) in the New England Journal of Medicine and presented at the 50th Union World Conference on Lung Health, held in Hyderabad, India.

The vaccine proved to reduce the incidence of TB in HIV-negative adults with latent TB infection.The results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination, says the report.

The trial was conducted in partnership with IAVI at 11 tuberculosis-endemic regions, in Kenya, South Africa and Zambia, involving 3,573 HIV-negative adults.

Participants were given two doses of either M72/AS01E or placebo 30 days apart. They were followed up for three years to detect evidence of pulmonary tuberculosis disease. According to the final analysis reported, 13 participants in the vaccine group developed active pulmonary tuberculosis compared to 26 participants in the placebo group.

Participants who received the vaccine showed an increased and a sustained M72-specific immune response through three years.

TB is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.5 million attributed deaths in 2018. According to WHO, one-quarter of the global population has latent TB infection, of whom approximately 10% will develop active pulmonary TB disease.

Currently, multi-drug resistant strains of TB are emerging and spreading globally, and the only available TB vaccine, BCG, does not provide proven and consistent protection in adults in TB-endemic countries.

World Health Organization targets for a decrease in the number of new TB cases by 90% and the number of TB deaths by 95% between 2015 and 2035, which necessitates more effective preventive measures such as new vaccine.

GSK’s M72/AS01E candidate vaccine contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the Adjuvant System AS01, which is also a component of GSK’s RTS,S malaria vaccine and vaccine against shingles, Shingrix.

“We are one more cautious, but exciting, step closer to a vaccine for tuberculosis,” said Dr Paula I Fujiwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union).

Welcoming the promising announcement from the results of the phase IIb trial of M72/AS01E Dr. Paula said, as researchers discuss how to move the trial into its final phase, we simultaneously need to be doing all we can to prevent tuberculosis with medications that we already have at our disposal.