M72/AS01E Tuberculosis Vaccine Description
M72/AS01E is a subunit vaccine candidate which contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the GlaxoSmithKline proprietary Adjuvant System AS01.
AS01E is the same adjuvant used in the Shingrix GSK vaccine.
M72/AS01E Tuberculosis Vaccine Indication
M72/AS01E is indicated to prevent Pulmonary Tuberculosis (TB) in adolescents and adults. This is good news since this population accounted for 89 percent of people who fell ill with TB in 2018.
An effective vaccine against tuberculosis administered in adolescents and adults would have a marked impact on tuberculosis control, including drug-resistant tuberculosis, through interruption of transmission, and it would help achieve the WHO target of ending the tuberculosis epidemic by 2035, said GSK.
It is estimated that 25 percent of the global population has latent TB infection, of whom, approximately 10 percent will develop active pulmonary TB disease.
M72/AS01E Tuberculosis Vaccine Dosage
M72/AS01E 2 doses administered intramuscularly in the deltoid region of the arm.
M72/AS01E Tuberculosis Vaccine Updates
January 27, 2020: London based GSK announced that it has licensed its M72/AS01E tuberculosis disease (TB) vaccine candidate to the Bill & Melinda Gates Medical Research Institute (MRI).
October 29, 2019: GSK and IAVI reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection.
These results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination. The candidate vaccine has an acceptable safety and reactogenicity profile.
Clinical Trial NCT01755598: Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
- The purpose of this Phase 2 study is to evaluate the safety, immunogenicity and protective efficacy of M72/AS01E vaccine against pulmonary TB, as compared to placebo in HIV negative adults with latent TB infection living in high TB burden countries (South Africa, Kenya, and Zambia) and aged 18 - 50 years.
- The study remains ongoing and the final analysis is planned in 2019.