Epidemiologic study to assess the IGRA positivity in populations with a high TBburden

Active, not recruiting

• Conditions: N/A

• Registration Number: CTRI/2023/01/048867
• Lead Sponsor: Bill & Melinda Gates Medical Research Institute (Gates MRI)

Brief Summary

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-15
• Last Update Posted: 2023-10-09

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 7520

Inclusion Criteria

• Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF) 2.
• Between 15 and 34 years of age (inclusive) 3.
• Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary and have no current plans to relocate from the study area for the duration of the study.

Exclusion Criteria

• History of active TB within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history [no documentation required]) 2.
• History of previous administration of an experimental Mtb vaccine 3.
• Unstable/uncontrolled chronic condition according to the judgment of the investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with positive IGRA, per site, calculated using the per protocol population.	IGRA status (positive/negative/indeterminate) | at screening (i.e) Day 1

Secondary Outcome Measures

Name	Time	Method
1. Proportion of participants with positive IGRA, summarized by age group (15 to 24 [inclusive], and	25 to 34 years of age [inclusive]) per site.

Trial Locations

Locations (2)

PCMC Post Graduate Institute, Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Post Graduate Institute of Medical Education and Research(PGIMER); 🇮🇳 Chandigarh, CHANDIGARH, India

PCMC Post Graduate Institute, Yashwantrao Chavan Memorial Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Deepali Gaikwad

Principal investigator

9767104009

drg1818@rediffmail.com