Last reviewed · How we verify
A Clinical Study Comparing the Immune Response to Revaccination With Intradermal BCG and Aerosol BCG in Previously BCG Vaccinated Healthy Adult Volunteers With and Without Type 2 Diabetes
The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2. explore if there are differences in response to re-vaccination in healthy volunteers with and without Type 2 Diabetes. It will involve 36 previously BCG-vaccinated participants. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.
Details
| Lead sponsor | University of Oxford |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 36 |
| Start date | 2024-04-03 |
| Completion | 2028-08-31 |
Conditions
- Tuberculosis
Interventions
- BCG Danish
Primary outcomes
- Intradermal vs. aerosol BCG in non-type 2 diabetics — Up to day 168
To compare the immunological response of BCG re-vaccination by the aerosol inhaled route to the intradermal route in healthy historically intradermally BCG-vaccinated volunteers. This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISpot and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood. This will also be measured using flow cytometry, ELISA and cytokine staining of BAL samples. This will be achieved by blood test done at each follow up visit and bronchoscopy to retrieve BAL sample at Day 14 visit for non- diabetic volunteers. - Intradermal (in type 2 diabetics) vs intradermal (in non-type 2 diabetics) — Up to day 168
To compare the immunological response of BCG re-vaccination by the intradermal route in historically intradermally BCG-vaccinated volunteers with Type 2 Diabetes and non-diabetic healthy adults. This will be measured using laboratory markers of innate and adaptive immunity, which may include ex-vivo ELISPOT and ELISAs, RNA sequence analysis and intracellular cytokine staining of blood. This will be achieved through the blood test done at each follow up visit.
Countries
United Kingdom