Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: BCG vaccine: Consenting study participants will be randomized 1:1 (male and female at 1:1 ratio) to receive either intradermal BCG vaccine or placebo inoculation. BCG vaccine will be ob
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will compare systematically BCG induced antibody and cTfh responses in a well-defined cohort of volunteers undergoing BCG inoculation with or without DM and a range of TB pre-existing immunity status. The study will expand our understanding of populations most suitable for successful BCG revaccination and provides essential knowledge for ongoing TB vaccine development efforts including the modified BCG (VPM1002) or attenuated M. tuberculosis (MTBVAC).Timepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Anuradha
International Center for Excellence in Research (ICER)
Outcome results
None listed