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OpenTrials
Completed

NCT Number: NCT06628544

Trained Immunity in Fungal Infection and Its Mechanism

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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Key information

Conditions

BCG Vaccination

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wuhan University

Wuhan, Hubei, China, 430072, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCG vaccination

Biological

BCG vaccination

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

Primary outcomes

  1. The level of IL-6

    Time frame: 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.

  2. The level of TGF-alpha

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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