NCT06628544

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

September 27, 2024

Last Update Submit

October 4, 2024

Conditions

BCG Vaccination

Keywords

immunitymetforminBCG

Outcome Measures

Primary Outcomes (2)

  • The level of IL-6

    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

    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

Study Arms (5)

BCG vaccination with taking metformin on the day 85

EXPERIMENTAL
Biological: BCG vaccinationDrug: Metformin is administered on the day 85

BCG vaccination without metformin

EXPERIMENTAL
Biological: BCG vaccination

Placebo

PLACEBO COMPARATOR
Other: Placebo

BCG vaccination with taking metformin on the day 0

EXPERIMENTAL
Biological: BCG vaccinationDrug: Metformin is administered on the day 0

BCG vaccination with taking metformin on the day 9

EXPERIMENTAL
Biological: BCG vaccinationDrug: Metformin is administered on the day 9

Interventions

BCG vaccinationBIOLOGICAL

BCG vaccination

BCG vaccination with taking metformin on the day 0BCG vaccination with taking metformin on the day 85BCG vaccination with taking metformin on the day 9BCG vaccination without metformin
Metformin is administered on the day 0DRUG

Metformin is administered on the day 0

BCG vaccination with taking metformin on the day 0
PlaceboOTHER

Placebo

Placebo
Metformin is administered on the day 9DRUG

Metformin is administered on the day 9

BCG vaccination with taking metformin on the day 9
Metformin is administered on the day 85DRUG

Metformin is administered on the day 85

BCG vaccination with taking metformin on the day 85

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy BCG-naive participants.
  • The ages range from 20 to 45.
  • Participants without any infections or immune deficiencies.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan University

Wuhan, Hubei, China, 430072, China

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Vaccines (BCG) and Drugs (Metformin)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 8, 2024

Study Start

September 1, 2020

Primary Completion

August 31, 2023

Study Completion

December 1, 2023

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)