Antibiotics and Vaccine Immune Responses Study

Launched by SOUTH AUSTRALIAN HEALTH AND MEDICAL RESEARCH INSTITUTE · Nov 17, 2023

Keywords

ClinConnect Summary

The Antibiotics and Vaccine Immune Responses Study is looking at how taking antibiotics might affect the body's response to the BCG vaccine, which helps protect against certain infections. The main goal is to see if reducing the bacteria in the gut with antibiotics has any impact on how well the vaccine works. The study is currently recruiting healthy adults aged 18 to 35 who have never received the BCG vaccine before and are willing to take a short course of antibiotics. Participants will also need to provide blood and stool samples over a period of about 5 to 7 months.

To be eligible, you should be in the specified age range and able to give your consent. It's important that you haven't been vaccinated with BCG or yellow fever vaccines before, and you should not be pregnant or planning to become pregnant during the study. Participants can expect to have a small skin biopsy and multiple sample collections, which will help researchers understand how the vaccine works in different conditions. If you meet the eligibility criteria and are interested, this study could provide valuable insights into vaccine effectiveness and gut health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • Previous BCG or YF vaccination
• • Previous YF infection
• • Evidence of latent TB infection (LTBI) (assessed through a questionnaire) (IGRA to confirm if needed)
• * People with contraindications for BCG vaccination:
• • malignancies involving bone marrow or lymphoid systems, primary or secondary immunodeficiencies, HIV infection
• • moderate/severe skin disease including eczema, dermatitis or psoriasis
• • requiring immunosuppressive drugs or other immune modifying drugs e.g. corticosteroids, non-biological immunosuppressants, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha)
• * People with contraindications to YF vaccination:
• • History of thymus disease, including myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome, thymic damage from chemoradiotherapy or graft-versus-host disease
• • YF vaccination is contraindicated in immunocompromised individuals, including individuals who have HIV infection, primary immunodeficiencies (including inherited IFNAR1 deficiency), or are taking corticosteroids or other immunosuppressive agents and haematopoietic stem cell transplant recipients
• • People who have had a haematopoietic stem cell transplant
• • Individuals with history of severe allergic reactions to egg or chicken proteins
• • Pregnant or breastfeeding or planning to become pregnant
• • History of renal disease/insufficiency
• • Tattoo obscuring BCG vaccination site(s)
• • Any history of severe allergic reaction or anaphylaxis to vaccination
• • People with chronic serious underlying illness
• • Have received any prescribed oral or intravenous antibiotic in the 28 days prior to study visits 1 and 4 (including isoniazid, rifampicin, streptomycin and ethambutol as these particular antibiotics have activity against M. bovis)