Trained Immunity in Fungal Infection and Its Mechanism

October 4, 2024 updated by: Zhibing Lu, Zhongnan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei, China
      • Wuhan, Hubei, China, China, 430072
        • Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: BCG vaccination with taking metformin on the day 85
Biological: BCG vaccination
BCG vaccination
Drug: Metformin is administered on the day 85
Metformin is administered on the day 85
Experimental: BCG vaccination without metformin
Biological: BCG vaccination
BCG vaccination
Experimental: BCG vaccination with taking metformin on the day 0
Biological: BCG vaccination
BCG vaccination
Drug: Metformin is administered on the day 0
Metformin is administered on the day 0
Experimental: BCG vaccination with taking metformin on the day 9
Biological: BCG vaccination
BCG vaccination
Drug: Metformin is administered on the day 9
Metformin is administered on the day 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
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.
Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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