Covid-19 U07.1
Conditions
Interventions
Group 1: This study will target healthy young adults in Germany, aged 18-40, who are going to be vaccinated with a licensed vaccine against COVID-19.
Stool, blood samples and temperature measurements
Sponsors
Department of Microbiome ScienceMax Planck Institute for Developmental BiologyEberhards Karls University of Tubingen
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Profile the intestinal microbiota and host immune response in healthy adults over the course of COVID-19 vaccination. 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). 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). c.Determine whether there are microbiota shifts associated with fever (i.e., changes in abundance or transcriptional activity associated with increased body temperature). | — |
Countries
Germany
Contacts
Public ContactMeral Esen
Eberhard Karls University of TübingenMedizinische Klinik Innere Medizin VIIInstitut für Tropenmedizin, Reisemedizin, Humanparasitologie, Kompetenzzentrum Tropenmedizin Baden-Württemberg
Outcome results
None listed