Advancing a Promising Tuberculosis Vaccine Candidate: MTBVAC
Abstract
Rationale: Tuberculosis (TB) kills more people than any other single infectious agent in the world. It is spread through the air when someone who is sick with TB coughs, sings, sneezes, or talks loudly, and multidrug-resistant (MDR) strains are spreading globally. Currently, there is only one vaccine to prevent TB, called Bacille Calmette-Guerin (BCG), but it is only effective against severe forms of childhood TB and is administered to newborn infants. However, the greatest TB disease burden is due to TB of the lung in adolescents and adults, which is not effectively prevented by BCG. It is adolescent and adult TB patients who are primarily responsible for spreading the disease. The World Health Organization (WHO) and the National Action Plan for Combating Multidrug-Resistant TB acknowledge the critical need for TB research and development of new, improved tools, especially new and more effective TB vaccines, to reach the WHO goal of ending the TB epidemic by 2035 and to stop the spread of MDR-TB globally and in the United States. The objective of the proposed study is to evaluate a promising new TB vaccine candidate called MTBVAC. MTBVAC is ready for a clinical trial that will test its safety and its ability to induce an immune response in adults who may have been previously exposed to TB in the environment. Many adults in high TB burden countries carry inactive, so-called “latent” TB infection that often does not progress to symptomatic disease. The study will help select the appropriate dose for MTBVAC in adults with and without latent TB infection. Results of this study will advance TB vaccine science and the development of a new, more effective TB vaccine to help stop the global spread of TB, including MDR-TB. Fiscal Year 2016 (FY16) Topic Areas/Area of Encouragement Addressed: Many of the countries where the US has a military presence have a high prevalence of TB, including MDR-TB, which makes this airborne disease a very real threat to the health of US military Service members, Veterans, and beneficiaries. The proposed research project addresses several of the FY16 Peer Reviewed Medical Research Program (PRMRP) topic areas, including Tuberculosis, Antimicrobial Resistance, and Vaccine Development for Infectious Disease. Under the Tuberculosis topic area, PRMRP has prioritized “development of novel TB vaccines” as an area of encouragement. Impact: In 2015, the number of people who developed TB in the United States increased for the first time in 23 years, from 9,421 in 2014 to 9,563 in 2015. Globally, in 2015, there were 10.4 million new cases of TB and 1.8 million deaths from TB, also an increase from 2014 estimates. The growing threat of MDR-TB and the co-epidemics of TB with HIV [human immunodeficiency virus] and diabetes make ending the TB epidemic more urgent than ever. The only available vaccine, BCG, has not been effective in controlling the TB epidemic, and safe, effective, affordable, and accessible vaccines are urgently needed to end this epidemic. It is anticipated such vaccines will be widely used both for high-risk populations in low TB burden countries (including the military, healthcare workers, and travelers) and within high TB burden countries. Public health impact modeling by the London School of Hygiene and Tropical Medicine (LSHTM) demonstrated that TB vaccines are likely to be highly impactful and cost-effective. A 60% efficacious TB vaccine could prevent 17 million TB cases by 2050. The same vaccine delivered to 90% of infants globally would avert an additional 5 million cases in the same period. Therefore, if safe and effective, MTBVAC will have significant global and US impact by preventing TB, including MDR-TB, a major worldwide social, economic, and health threat.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710656
Entities
People
- Ann Ginsberg
Organizations
- United States Army