Advances in the development of biomarkers to evaluate the protective efficacy of tuberculosis vaccine

Lee Young-Ran, Jeong Hye-Sook, Shin Eunkyung, Yun Jinseung, Yoo Jung Sik, and Chung Gyung Tae
Division of Vaccine Research, Center for Infectious Disease Research, KNIH, KCDC

Background: One of the most effective interventions for tuberculosis is immunization with Bacille-Calmette-Guerin (BCG) vaccine, which is the only licensed vaccine against tuberculosis. However, its protective efficacy against M. tuberculosis infection in adults is limited. Thus, the development of a new vaccine is urgently needed. Currently, there are no validated biomarker targets for the evaluation of new tuberculosis vaccine candidates.
Current status: Biomarkers can help in developing new tuberculosis vaccine candidates by identifying immune mechanisms and accurately assessing the immunogenicity and protective efficacy of a vaccine in multiple ways. Understanding the interplay among the host immune response, vaccine candidate, and M. tuberculosis infection may provide a platform for the identification of suitable biomarkers.
Future perspective: In this article, we review current methods for evaluating the efficacy of tuberculosis vaccine and biomarkers used by global tuberculosis research teams and consider using these evaluation methods and biomarkers for assessing the efficacy of the tuberculosis vaccine in Korea.

Keywords: Biomarkers, Tuberculosis, Vaccine efficacy, Host immune response, Vaccine candidate