Table 1 Schedule of enrolment and assessments

Enrollment

Eligibility screen

X

Informed consent

X

Allocation

X

Assessments

General information (date of enrollment, demographic data e.g. age, sex, educational level, residential and housing status, care level, disabilities, migration status)

X

X

Drug therapy / intake (diagnoses, pre-existing conditions, smoking status, previous SARS-CoV-2 infections, immunosuppressive or immunomodulating drug therapy and if they have been paused during vaccination (T1))

X

(X)

Vaccination status (timing of COVID-19 vaccinations, number of vaccinations, name of applied COVID-19 vaccines)

X

Serum / Plasma (ELISA / multiplex analyses for e.g. anti-SARS-COV-2 S1 specific IgG/IgA)

X

X

X

PBMCs (Analysis of cellular immune responses against SARS-CoV-2 in HO cohort)

X

(HO-1)

X (HO-2)

Social Participation and general wellbeing (Index for the Assessment of Health Impairments (IMET)) [20]; additional self developed items to measure social participations and overall wellbeing in the pandemic situation; PHQ-4 Questionnaire [21, 22])

X

X

X

X

Attitudes towards vaccination (Questionnaire items from the Preventable Infectious Disease Survey from the German Federal Center for Health Education [23], additional self developed items specific to measure COVID-19 attitudes ex-ante (T0) and post-vaccination (T1), experience with previous vaccinations (e.g. side effects)

X

X

Experience with self-administered capillary blood taking (willingness to draw blood independently, prior experience with medication injections or blood glucose monitoring (T0), whether independent blood collection was successful or help (doctors, pharmacies) was sought (T1–T3))

X

X

X

X

Qualitative Interviews (semi-structured interviews on social participation)

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