Trained Immunity in Fungal Infection and Its Mechanism

Early Phase 1

Completed

• Conditions: BCG Vaccination
• Interventions: Biological: BCG vaccination; Other: Placebo; Drug: Metformin is administered on the day 9; Drug: Metformin is administered on the day 85; Drug: Metformin is administered on the day 0

• Registration Number: NCT06628544
• Lead Sponsor: Zhongnan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-01
• Study First Submitted: 2024-09-27
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCG vaccination with taking metformin on the day 9	Metformin is administered on the day 9	-
BCG vaccination without metformin	BCG vaccination	-
BCG vaccination with taking metformin on the day 85	BCG vaccination	-
BCG vaccination with taking metformin on the day 85	Metformin is administered on the day 85	-
Placebo	Placebo	-
BCG vaccination with taking metformin on the day 0	BCG vaccination	-
BCG vaccination with taking metformin on the day 0	Metformin is administered on the day 0	-
BCG vaccination with taking metformin on the day 9	BCG vaccination	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wuhan University; 🇨🇳 Wuhan, Hubei, China, China