Vaccination and the human intestinal microbiome

Recruiting

Conditions: Covid-19U07.1

Registration Number: DRKS00027324

Lead Sponsor: Department of Microbiome ScienceMax Planck Institute for Developmental BiologyEberhards Karls University of Tubingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 256

Inclusion Criteria

Participants must be adults 18-40 years of age, with no underlying health conditions, belonging to the Robert Koch priority group 4 (de-prioritized for vaccination). Participants must intend to be vaccinated against COVID-19 and be able to receive their vaccination during the study timeline (~Sept 2021-Dec 2022). Any of the COVID-19 vaccinations approved by the Robert Koch Institute at the time of study participation (e.g., BioNTech/Pfizer, Moderna, Johnson & Johnson or other commercially available vaccines) will be permitted for inclusion in the study, including booster shots. Participants must be able to read and understand German or English to provide informed consent for themselves.

Exclusion Criteria

Exclusion criteria include known gastrointestinal disorders (e.g., Inflammatory Bowel Disease or Celiac Disease), recent antibiotics use (any antibiotics taken in the three months prior to study participation), and pregnancy. Any health factor which places someone at higher risk of COVID-19 disease, and therefore in a higher vaccine priority group (1-3) according to the Robert Koch Institute will also be excluded. These exclusion risk factors, as listed by the Robert Koch Institute, include diabetes mellitus, obesity (BMI>30), asthma, autoimmune diseases, neurological diseases, cancer, and diseases of the lung, heart, liver, or kidney. Immunocompromised and immunosuppressed people are also explicitly excluded.
However, healthy individuals who receive vaccine prioritization for occupational reasons (for example, researchers working at the hospital campus) are not excluded from the study.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Profile the intestinal microbiota and host immune response in healthy adults over the course of COVID-19 vaccination.<br>a.Determine whether the baseline microbiota (average longitudinal composition prior to vaccination) is associated with the strength of the subsequent immune response to vaccination (fever response, transcription of inflammatory markers in feces if present, serum antibody levels).<br>b.Determine whether there are microbiota shifts associated with vaccination (i.e., consistent changes in abundance or transcriptional activity following the vaccine compared to baseline).<br>c.Determine whether there are microbiota shifts associated with fever (i.e., changes in abundance or transcriptional activity associated with increased body temperature).

Secondary Outcome Measures