NCT06628544

Trained Immunity in Fungal Infection and Its Mechanism

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• BCG Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccination	BCG vaccination
DRUG	Metformin is administered on the day 0	Metformin is administered on the day 0
OTHER	Placebo	Placebo
DRUG	Metformin is administered on the day 9	Metformin is administered on the day 9
DRUG	Metformin is administered on the day 85	Metformin is administered on the day 85

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-08-31
• Completion: 2023-12-01
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: China