Vaccination and the human intestinal microbiome (µHEAT)
- Conditions
- COVID-19 Vaccination
- Registration Number
- DRKS00032373
- Lead Sponsor
- Max Planck-Institut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 187
Participants were adults 18-40 years of age, with no underlying health conditions, belonging to the Robert Koch priority group 4. 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 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 Interplay of the intestinal microbiome and fever and antibody responses to SARS-CoV-2 vaccination
- Secondary Outcome Measures
Name Time Method Temporal responsiveness of the intestinal microbiome to immunisation against SARS-CoV-2