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

Status: Recruiting

Location: See location...

Intervention Type: Drug, Biological

Study Type: Interventional

Study Phase: Phase 4

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?

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 35

Healthy Volunteers: t

View:

• 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

• Willing to undergo a punch biopsy (Arm 1)

• Willing to have up to 7 blood samples and 3 stool samples collected over 5-7 months

• Not pregnant or intending to get pregnant for the duration of the study (a pregnancy test will be offered to females)

Locations

Other Locations

Australia

South Australian Health and Medical Research Institute

RECRUITING

Adelaide

Contact Information

Primary

David Lynn

david.lynn@sahmri.com

+61 8 8128 4053

Time Frame

Start Date: 2023-11-23

Estimated Completion Date: 2028-10-01

Participants

Target number of participants: 348

Treatments

Experimental: Substudy 1 - BCG vaccine, antibiotics and 2nd BCG vaccine

Randomised to receive antibiotics and a BCG vaccine at visit 1 and a second BCG vaccine 6 months later

Experimental: Substudy 1 - BCG vaccine, no antibiotics and 2nd BCG vaccine

Randomised to receive no antibiotics and a BCG vaccine at visit 1 and a second BCG vaccine 6 months later

Experimental: Substudy 1 - BCG vaccine, antibiotics and placebo vaccine

Randomised to receive antibiotics, a placebo vaccine at visit 1 and a BCG vaccine 6 months later

Experimental: Substudy 1 - BCG vaccine, no antibiotics and placebo vaccine

Randomised to receive no antibiotics, a placebo vaccine at visit 1 and a BCG vaccine 6 months later

Experimental: Substudy 2 - Yellow Fever vaccine, antibiotics and BCG vaccine

Randomised to receive antibiotics, a BCG vaccine at visit 1 and a Yellow Fever vaccine 3 months later

Experimental: Substudy 2 - Yellow Fever vaccine, no antibiotics and BCG vaccine

Randomised to receive no antibiotics, a BCG vaccine at visit 1 and a Yellow Fever vaccine 3 months later

Experimental: Substudy 2 - Yellow Fever vaccine, antibiotics and placebo vaccine

Randomised to receive antibiotics, a placebo vaccine at visit 1 and a Yellow Fever vaccine 3 months later

Experimental: Substudy 2 - Yellow Fever vaccine, no antibiotics and placebo vaccine

Randomised to receive no antibiotics, a placebo vaccine at visit 1 and a Yellow Fever vaccine 3 months later

Related Therapeutic Areas

Viral Hemorrhagic Fever

Yellow Fever

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