Trained Immunity in Fungal Infection and Its Mechanism

The Role of Trained Immunity in Fungal Infection and the Mechanism Behind it

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06628544

Enrollment

Registered

2024-10-08

Start date

2020-09-01

Completion date

2023-12-01

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BCG Vaccination

Keywords

immunity, metformin, BCG

Brief summary

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.

Interventions

BIOLOGICALBCG vaccination

BCG vaccination

DRUGMetformin is administered on the day 0

Metformin is administered on the day 0

OTHERPlacebo

Placebo

DRUGMetformin is administered on the day 9

Metformin is administered on the day 9

DRUGMetformin is administered on the day 85

Metformin is administered on the day 85

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Vaccines (BCG) and Drugs (Metformin)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy BCG-naive participants. * The ages range from 20 to 45. * Participants without any infections or immune deficiencies.

Exclusion criteria

* Participants when infections or other illnesses occurred during the clinical trial. * Participants who have a fever of unknown causes during the clinical trial. * Participants who have gotten other vaccines during the clinical trial.

Design outcomes

Primary

Measure	Time frame	Description
The level of IL-6	Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis	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.
The level of TGF-alpha	Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026