The clinical trial of a vaccine that prevents active pulmonary tuberculosis has revealed positive results, according to a recent study.
GSK has announced that M72/AS01E candidate vaccine has significantly reduced pulmonary tuberculosis disease in adults after two years of testing. The clinical trial has been conducted in regions where tuberculosis is endemic, including South Africa.
The findings were published in the New England Journal of Medicine this week.
The test involved over 3,000 participants who are HIV-negative adults aged 18 to 50 years old from Kenya, Zambia, and South Africa. They were divided into two groups: one group was to receive two doses of M72/AS01E, while the other group was given placebo injections.
After two years, 10 participants from the vaccine group developed active pulmonary tuberculosis disease. To compare, 22 people who received placebo shots developed the disease. The vaccine reports an overall efficacy of 54 percent.
"These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis," explained Emmanuel Hanon of R&D, Global Vaccines GSK. "This scientific breakthrough — one of the very few in tuberculosis vaccine development for almost 100 years — has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant."
According to GSK, a final analysis that will detail efficacy, safety, reactogenicity, and immunogenicity will be performed in 2019. The study was conducted in partnership with Aeras, which is funded by the Bill & Melinda Gates Foundation, among many others.
Tuberculosis (TB) is caused by bacteria that attack the lungs and damage other parts of the body. It spreads from person to person through air.
In 2016, the Center for Disease Control and Prevention said that 9,272 new cases of tuberculosis were reported in the United States. Worldwide, it is the leading cause of death through infectious disease, with 1.6 million deaths recorded in 2017.
Symptoms of tuberculosis include coughing that lasts longer than three weeks, coughing up blood, pain in the chest, weakness or fatigue, weight loss, fever, chills, and night sweats. People who have tested positive to HIV are most at risk of developing tuberculosis because of their weakened immune system. The elderly people, babies and young children, and people who have previously been infected with the disease are at high risk of developing tuberculosis.