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Trained Immunity in Fungal Infection and Its Mechanism

NCT06628544 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-10-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-08-31
Completion
2023-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06628544 on ClinicalTrials.gov