Health Trials

Antibiotics and Vaccine Immune Responses Study

ConditionVaccine Response Impaired
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-35
SponsorSouth Australian Health and Medical Research Institute

About this trial

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?

Eligibility criteria

Qualifiers

18-35 years old

Provided a signed and dated informed consent form

BCG naïve (Arm 1) and BCG and YF vaccine naïve (Arm 2)

Willing to take short antibiotic course

Disqualifiers

Previous BCG or YF vaccination

Previous YF infection

Evidence of latent TB infection (LTBI) (assessed through a questionnaire) (IGRA to confirm if needed)

malignancies involving bone marrow or lymphoid systems, primary or secondary immunodeficiencies, HIV infection

Trial design

Treatments tested in this trial

  • BCG vaccine
  • Yellow Fever vaccine
  • Vancomycin Oral Capsule
  • Neomycin Oral Product
  • Metoclopramide (Maxolon)
  • Loperamide HCl

Treatment groups

348 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

South Australian Health and Medical Research Institute

Lead sponsor

Royal Adelaide Hospital

Collaborator

Flinders University

Collaborator

University of Sydney

Collaborator

Telethon Kids Institute

Collaborator

Centenary Institute

Collaborator

Source ClinicalTrials.gov