U07.1 K50 K51 K52
Conditions
Interventions
Group 1: Fully vaccinated healthcare workers incl. students and trainees
Group 2: Fully vaccinated patients with psychiatric illness and severe psychological distress who are not receiving immunosuppr
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: - Fully vaccinated against COVID-19 (one or two vaccinations depending on manufacturer), male, female, diverse. - Age: > 18 years, for CED patients >12 years - Sufficient knowledge of the German language - Internet access for online-supported survey - Signed informed consent to participate in the study (for minors additionally of the persons with custody) - Belonging to one of the three groups - Employees of the LMU University Hospital, or trainees/students/interns at the hospital - Patients with chronic inflammatory bowel diseases with immunosuppressive therapy with connection to CED outpatient clinic at LMU University Hospital - Patients with mental illnesses without immunosuppressive therapy with connection to the Psychiatric Clinic at LMU University Hospital
Exclusion criteria
Exclusion criteria: - Inclusion criteria not met - Psychiatric illness with recent (within the past year) or active suicidal ideation or behaviors/other reasons that may make the potential participant unsuitable for the study in the opinion of the investigator(s). - Individuals who have received blood or plasma products or immunoglobulins in the 60 days prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of the genetic, metabolic, or lifestyle factors associated with the magnitude and expression of the immune response after SARS-CoV-2 immunization, taking into account known factors influencing the immune response of COVID-19 vaccination, such as type of vaccine, interval between 1st or 2nd vaccine dose, age, and presence of a primary or secondary (possibly drug-induced) immunodeficiency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survey-related questions: - What is the acceptability of healthcare workers regarding participation in a pseudonymous online survey and monitoring of symptoms via a mobile app? Virological-methodological questions: - Is the validity of determining AK from dried blood on filter cards compared to determining neutralizing AK in blood for assessing vaccination protection comparable? - After COVID-19 vaccination, what is the percentage of neutralizing AK to IgG-AK against wild type and its variants? Epidemiologic questions: - What are the symptoms and severity of breakthrough infections in the studied populations? - What is the risk of infection for employees of the LMU hospital who had contact with an infected person (patient, employee, private contact person)? Psychological question: - What is the level of stress in the three cohorts studied during the study period? - For healthcare workers, does the stress level depend on the occupational group and or the area of assignment? - How good is the correlation of questionnaire collected stress score (PSQ) and measured immunologically relevant stress markers in blood and saliva? Metabolic questions: - Do dietary habits influence vaccination response? - Does the intake of supplements and vitamins influence the vaccination response? - Does the consumption of noxious substances (cigarettes, alcohol) influence the vaccination response? | — |
Countries
Germany
Outcome results
None listed