Trained Immunity in Fungal Infection and Its Mechanism

Zhongnan Hospital

Status and phase: Completed; Early Phase 1

Conditions: BCG Vaccination

Treatments: Biological: BCG vaccination; Drug: Metformin is administered on the day 0; Other: Placebo; Drug: Metformin is administered on the day 9; Drug: Metformin is administered on the day 85

Study type: Interventional

Funder types: Other

Identifiers

NCT06628544

2020005

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 5 patient groups, including a placebo group

BCG vaccination with taking metformin on the day 85

Experimental group

Treatment:

Drug: Metformin is administered on the day 85

Biological: BCG vaccination

BCG vaccination without metformin

Experimental group

Treatment:

Biological: BCG vaccination

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

BCG vaccination with taking metformin on the day 0

Experimental group

Treatment:

Drug: Metformin is administered on the day 0

Biological: BCG vaccination

BCG vaccination with taking metformin on the day 9

Experimental group

Treatment:

Drug: Metformin is administered on the day 9

Biological: BCG vaccination