Skip to main content

ORIGINAL RESEARCH article

Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1498448
This article is part of the Research Topic Community Series in Research Advances of Tuberculosis Vaccine and its Implication on COVID-19: Volume III View all 3 articles

Screening and Preclinical Assessment of Novel Mycobacterium tuberculosis Recombinant Antigens based Tuberculin Skin Testing

Provisionally accepted
Xichao Ou Xichao Ou 1Eryong Liu Eryong Liu 1*Faiqa Rashid Faiqa Rashid 2Shaojun Pei Shaojun Pei 3Guoqin Zhang Guoqin Zhang 4Richard Anthony Richard Anthony 5Ruida Xing Ruida Xing 1Fei Huang Fei Huang 1Hui Xia Hui Xia 1Yang Zheng Yang Zheng 1*Yuanyuan Song Yuanyuan Song 1*Yang Zhou Yang Zhou 1Bing Zhao Bing Zhao 1*Shengfen Wang Shengfen Wang 1*Minggui Lin Minggui Lin 6*Lin Zhou Lin Zhou 1*Yanlin Zhao Yanlin Zhao 1*
  • 1 Chinese Center For Disease Control and Prevention, Beijing, China
  • 2 Capital University of Science & Technology, Islamabad, Islamabad, Pakistan
  • 3 Peking University, Beijing, Beijing Municipality, China
  • 4 Tianjin Centers for Disease Control and Prevention, Tianjin, China
  • 5 National Institute for Public Health and the Environment (Netherlands), Bilthoven, Utrecht, Netherlands
  • 6 Beijing Tsinghua Changgeng Hospital, Tsinghua University, Beijing, Beijing Municipality, China

The final, formatted version of the article will be published soon.

    A new class of Mycobacterium tuberculosis (MTB) antigen-based skin tests was recommended by WHO for the diagnosis of TB infection. However, their performance in some settings remains suboptimal. Our study focused on screening novel MTB recombinant antigens for skin tests and evaluating their preclinical safety and efficacy for TB infection detection. We produced 24 recombinant MTB antigens using Escherichia coli BL21(DE3) and assessed their ability to detect tuberculosis infection through skin test. Of these, three antigens (ESAT6-MPT64 (E-M), ESAT6-CFP10-MPT64 (E-C-M), and ESAT6-TB7.7-CFP10 (E-7.7-C)) met the criteria for skin test interpretation in preclinical trials. Notably, E-M demonstrated comparable skin reaction intensity to EC (P > 0.05) with no cross-reactivity to BCG. Furthermore, E-M exhibited a strong preclinical safety profile, with no significant physiological, biochemical, or histopathological abnormalities. It also showed high specificity, distinguishing MTB infection from BCG vaccination and nontuberculous mycobacteria (NTM) infection in sensitized guinea pigs. These findings suggest that the E-M recombinant antigen holds promise for TB infection detection, demonstrating strong safety and efficacy at the preclinical stage. Further clinical trials are necessary to evaluate its clinical applicability.

    Keywords: MTB recombinant antigens, Tuberculin skin test, screening, Preclinical efficacy, EM

    Received: 19 Sep 2024; Accepted: 07 Feb 2025.

    Copyright: © 2025 Ou, Liu, Rashid, Pei, Zhang, Anthony, Xing, Huang, Xia, Zheng, Song, Zhou, Zhao, Wang, Lin, Zhou and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Eryong Liu, Chinese Center For Disease Control and Prevention, Beijing, China
    Yang Zheng, Chinese Center For Disease Control and Prevention, Beijing, China
    Yuanyuan Song, Chinese Center For Disease Control and Prevention, Beijing, China
    Bing Zhao, Chinese Center For Disease Control and Prevention, Beijing, China
    Shengfen Wang, Chinese Center For Disease Control and Prevention, Beijing, China
    Minggui Lin, Beijing Tsinghua Changgeng Hospital, Tsinghua University, Beijing, 102218, Beijing Municipality, China
    Lin Zhou, Chinese Center For Disease Control and Prevention, Beijing, China
    Yanlin Zhao, Chinese Center For Disease Control and Prevention, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.