GSK’s candidate vaccine shows overall efficacy of 50% over three-year period
In a significant step towards developing vaccine against tuberculosis, final analysis of Phase IIb study of pharma major GlaxoSmithKline (GSK) ‘s candidate vaccine M 72 / AS 01 E ‘ demonstrated a sustained level of protection against active tuberculosis’. An overall efficacy of 50% during the three years after vaccination was demonstrated.
The study results were presented at a press conference here on Tuesday, as part of the 50 th Union World Conference on Lung Health.
On the guidelines of the press conference, director of Clinical Research and Development at GSK Vaccines, Olivier Van Der Meeren, said the total sample size of the trial was 3, 573 participants who were HIV negative, and were latently infected with tuberculosis. The study was sponsored by GSK and conducted in partnership with the International AIDS Vaccine Initiative (IAVI).
The participants, both men and women aged between 18 and 50 years, were from 11 sites in Kenya, South Africa and Zambia. While half of them were administered two doses of the candidate vaccine M 72 / AS 01 E, the remaining half were given two doses of a placebo. Thereafter, they were followed for three years to detect evidence of pulmonary tuberculosis disease.
As per the final analysis, 13 positive cases of active pulmonary TB disease were confirmed in the M 72 / AS 01 E group, and 26 from the group who were given placebo. “That is how we say the vaccine reduces the risk to develop TB by 50%,” Mr Olivier said. The final analysis of the trial is also published in The New England Journal of Medicine.
Askedhow many more phases of trials are required, GSK Vaccine’s Chief Medical Advisor, Thomas Breuer said a large Phase 3 trial is “definitely needed to firmly establish the efficacy”, and it will take several years for final Phase-3 results to be available.
Senior technical advisor at IAVI, Ann M Ginesberg said there are 14 other TB vaccine candidates in pipeline and that IAVI is working with at least two other companies.
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