Antibiotics and Vaccine Immune Responses Study

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?

Conditions

• Vaccine Response Impaired

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

Sponsors & Collaborators

• Royal Adelaide Hospital

  collaborator OTHER

• Flinders University

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Telethon Kids Institute

  collaborator OTHER

• Centenary Institute

  collaborator UNKNOWN

• South Australian Health and Medical Research Institute

  lead OTHER

Principal Investigators

• Simone Barry · Royal Adelaide Hospital

• David Lynn · South Australian Health and Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-23

Primary Completion

2027-10-01

Completion

2028-10-01

Countries

• Australia

Study Locations