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RECRUITING
NCT06148025
PHASE4

Antibiotics and Vaccine Immune Responses Study

Sponsor: South Australian Health and Medical Research Institute

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?

Official title: A Human Experimental Medicine Study to Assess Whether the Gut Microbiota Regulates Specific and Non-specific Immune Responses to Vaccination

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2023-11-23

Completion Date

2028-10-01

Last Updated

2025-12-10

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

BCG vaccine

0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus

BIOLOGICAL

Yellow Fever vaccine

0.5ml injected subcutaneously

DRUG

Vancomycin Oral Capsule

500mg every 6 hours for 3 days

DRUG

Neomycin Oral Product

1000mg every 6 hours for 3 days

DRUG

Metoclopramide (Maxolon)

10mg every 8 hours

DRUG

Loperamide HCl

2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day

Locations (1)

South Australian Health and Medical Research Institute

Adelaide, South Australia, Australia