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Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on day 6). On the day 0 (total 20; n = 10 for BCG vaccination, n = 10 for BCG vaccination plus taking metformin), day 14 (total 30; n=15 for BCG vaccination, n = 15 for BCG vaccination plus taking metformin), day 90 (total 26; n = 13 for BCG vaccination, n=13 for BCG vaccination plus taking metformin) of BCG vaccination, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCG vaccination with taking metformin on the day 85 | Experimental |
| |
| BCG vaccination without metformin | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BCG vaccination with taking metformin on the day 0 | Experimental |
| |
| BCG vaccination with taking metformin on the day 9 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG vaccination | Biological | BCG vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| The level of IL-6 | After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa. | Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis |
| The level of TGF-alpha | After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa. | Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan University | Wuhan | Hubei, China | 430072 | China |
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Vaccines (BCG) and Drugs (Metformin)
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| Metformin is administered on the day 0 | Drug | Metformin is administered on the day 0 |
|
| Placebo | Other | Placebo |
|
| Metformin is administered on the day 9 | Drug | Metformin is administered on the day 9 |
|
| Metformin is administered on the day 85 | Drug | Metformin is administered on the day 85 |
|