National Institute of Health

KNIH (Korea National Institute of Health)

- 2025 Grant Program

Official Announcement on International Collaborative Research on Tuberculosis

(Sponsored by the Korea National Institute of Health, KDCA)

1. Background and Rationale

The Korea National Institute of Health (KNIH), a research institute of the Korea Disease Control and Prevention Agency (KDCA), is dedicated to promoting public health through research on both infectious and non-infectious diseases.

Multidrug-resistant tuberculosis (MDR-TB) is a major global public health threat, particularly in high-burden countries. Rapid and accurate diagnosis is essential for effective TB treatment and prevention of transmission owing to delayed therapy. Although the Gene Xpert test is widely used to detect rifampicin resistance, it does not provide a comprehensive assessment of resistance to other anti-TB drugs, including newer medications. This highlights the urgent need for a rapid, comprehensive diagnostic tool capable of detecting resistance to both first-line and novel anti-TB drugs.

This study aims to evaluate the clinical efficacy and operational feasibility of novel MDR-TB diagnostic technologies in a high-burden country. The study findings will provide the scientific evidence needed for global evaluation and potential policy recommendations.

2. Project Details

2.1. Title

Overseas clinical studies evaluating the efficacy of rapid diagnostic technologies for multidrug-resistant tuberculosis (MDR-TB)

2.2. Project Duration

Within 30 months from the contract date:

- Year 1: Contract date - Mar 31, 2026

- Year 2: Apr 1, 2026 - Dec 31, 2026

- Year 3: Jan 1, 2027 - Dec 31, 2027

2.3. Funding

The annual fund will be approximately 72,000 USD (100,000,000 KRW).

2.4 Countries

Countries with a high TB burden in Asia (incidence > 100/100,000 people)

2.5. Eligibility of Applicants

Must have a Ph.D. or an M.D.

2.6. Research Areas of Focus

2.6.1. Objective

To evaluate the performance of a targeted next-generation sequencing (tNGS)-based drug susceptibility testing (DST) kit for the detection of resistance to anti-tuberculosis (TB) drugs.

Specific Objectives:

a. To evaluate the performance of a Next-generation sequencing (NGS) - based kit using clinically isolated Mycobacterium tuberculosis strains.

b. To evaluate the performance of a Next-generation sequencing (NGS) - based kit using sputum samples collected from patients newly diagnosed with multidrug-resistant tuberculosis (MDR-TB).

c. To compare test results generated by the NGS-based kit against baseline diagnostic data, including phenotypic DST, molecular assays, and sequencing data.

2.6.2. Study Design and Methodology

● Establishment of Single- or Multicenter Clinical Research Network:

The study will involve one or two hospital (health center or clinic) sites. These sites will collaborate to recruit TB patients and implement standardized study procedures.

● Subject Recruitment and Sample Collection:

o This study will enroll more than 200 patients aged 18–64 years with DS-TB, resistance to 1st and 2nd line drugs, and new drugs (e.g., bedaquiline, delamanid, and pretomanid).

o Baseline diagnostic information, including culture results, phenotypic drug susceptibility testing (MGIT pDST), and molecular assay (e.g., Xpert MTB/RIF, Xpert MTB/XDR) results, will be collected for each participant.

- Sensitivity, Specificity

o Sputum samples will be collected before TB treatment initiation.

o Sample processing and storage will follow the standard procedures of each participating institution.

● Evaluation of the tNGS-DST Kit:

o tNGS using the Illumina platform will be performed at the Advanced Molecular Technologies Laboratory at RITM.

o Primers for tNGS-based DST and protocols will be provided.

o Target genes related to resistance to 13 anti-TB drugs will be evaluated.

o Performance evaluation will be done using more than 100 clinical M. tuberculosis isolates.

- DS-TB (over 50 clinical MTB isolates), resistance to 1st and 2nd line drugs, and new drugs (e.g., bedaquiline, delamanid, and pretomanid).

o The test results will be compared with existing pDST, Xpert, and Sanger sequencing results.

- Sensitivity, Specificity

o DNA quality (concentration and purity) will be assessed, and the library construction will be validated.

o Performance will be evaluated using at least 200 sputum samples collected from enrolled patients.

- DS-TB (over 100 sputum samples), resistance to 1st and 2nd line drugs, and new drugs (e.g., bedaquiline, delamanid, and pretomanid).

● Analysis Protocol:

Data analysis will be conducted by both parties using software and protocols provided by the Korea National Institute for Health. The performance metrics included sensitivity, specificity, and coverage.

2.6.3. Sample Collection and Data Management

● Sample collection and processing will be performed according to the standard operating procedures of each research institution.

● Samples will be stored in a central biobank designated as the host country for up to 10 years.

● Sample (DNA from MTB isolates and sputum samples) and data transfer will comply with ethical and legal regulations of both countries (with separate informed consent forms).

- RCA, MOA, MTA, DTA

● Encrypted unique identifiers will be used to protect personal information.

2.6.4. Sample Collection and Data Management

● The study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines.

● IRB review board approvals from each participating institution.

Written informed consent will be obtained from all study participants. Explaining the objective of the study, procedures, potential risks and benefits. Participation will be entirely voluntary, and patients will be able to withdraw from the study at any time without affecting their routine care.

3. Affiliation

Government institute, university, hospital, etc.

4. Reporting System

The application should be submitted in English via email before September 10, 2025.

Please use MS Word format (important).

5. Key Dates

- Application opens on August 28, 2025

- Application due by September 10, 2025

* Letter of intent and project proposal should be submitted via email (sem21c@korea.kr)

Confirmation of your submission will be sent via email within three days.

- Review due September 17, 2025

- Result notification (via email) September 22, 2025

6. Contact

sem21c@korea.kr

(28159)

187, Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Division of Bacterial Disease Research, Center for Infectious Disease Research, National Institute of Health, Korea Disease Control and Prevention Agency, South Korea

TEL: +82-43-719-8462

Download

• Research Proposal(Form)