TB vaccination in diabetes populatio
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitus
- Registration Number
- CTRI/2022/07/044500
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Screening phase:
Willingness to undergo HIV testing.
Willingness to receive either intradermal BCG vaccine or placebo inoculation.
Willingness to provide repeat venous blood samples at D-3, D0 (the day of BCG or placebo inoculation), D7, D14, D28 and D56.
Willingness to have samples and data stored.
Able to provide informed consent.
Study phase:
Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows:
Type 1 and 2 Diabetes will be included in the study. We cannot differentiate between Type1 and Type 2 diabetes based on HbA1c.
Group I: Latent tuberculosis infection (LTBI) negative long-term controllers no Diabetes mellitus (DM);
Group II: LTBI without Diabetes mellitus (DM);
Group III: LTBI Negative with Diabetes mellitus (DM); and
Group IV: LTBI with Diabetes mellitus (DM).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method