Trained Immunity in Fungal Infection and Its Mechanism

NCT ID: NCT06628544

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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BCG Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Vaccines (BCG) and Drugs (Metformin)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BCG vaccination with taking metformin on the day 85

Group Type EXPERIMENTAL

BCG vaccination

Intervention Type BIOLOGICAL

BCG vaccination

Metformin is administered on the day 85

Intervention Type DRUG

Metformin is administered on the day 85

BCG vaccination without metformin

Group Type EXPERIMENTAL

BCG vaccination

Intervention Type BIOLOGICAL

BCG vaccination

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

BCG vaccination with taking metformin on the day 0

Group Type EXPERIMENTAL

BCG vaccination

Intervention Type BIOLOGICAL

BCG vaccination

Metformin is administered on the day 0

Intervention Type DRUG

Metformin is administered on the day 0

BCG vaccination with taking metformin on the day 9

Group Type EXPERIMENTAL

BCG vaccination

Intervention Type BIOLOGICAL

BCG vaccination

Metformin is administered on the day 9

Intervention Type DRUG

Metformin is administered on the day 9

Interventions

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BCG vaccination

BCG vaccination

Intervention Type BIOLOGICAL

Metformin is administered on the day 0

Metformin is administered on the day 0

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Metformin is administered on the day 9

Metformin is administered on the day 9

Intervention Type DRUG

Metformin is administered on the day 85

Metformin is administered on the day 85

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhibing Lu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuhan University

Wuhan, Hubei, China, China

Site Status

Countries

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China

Other Identifiers

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2020005

Identifier Type: -

Identifier Source: org_study_id

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