SARS-CoV-2 infection prevention
Conditions
Sponsors
Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are =18 years on the day of screening 2. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry 3. Have received two doses of SARS-CoV-2 vaccines (Moderna, Biontech/Pfizer or Astra Zeneca) or one dose of Johnson and Johnson SARS-CoV-2 vaccine according to recommendations in the label and/or national guidelines at least 6 months before study entry 4. Have the technical requirements to complete online questionnaires (Smartphone) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in this study if they: 1. Had grade 3 adverse effects from the vaccination reported 2. Any other contraindication to any of the vaccine compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evidence of efficacy and safety of a third vaccination in real-live setting is still missing. The aim of this study is to provide scientific support to the vaccination campaign of the City of Vienna by performing a population-based study to generate evidence on efficacy and safety of a third vaccination against SARS-CoV-2 in a real world setting. The expected magnitude and broad range of this epidemiological study would enable us to take into account various factors associated with immune response as well as safety.;Secondary Objective: Secondary aims: - to evaluate stability of a humoral immune response over time and the effect of a third vaccination on incidence and severity of SARS-CoV-2 infection (for participants enrolled in study extension only) - to assess the influence of parallel Influenza vaccination on the efficacy and safety of COVID-19 vaccination ;Primary end point(s): Individual factors associated with total antibody titers as well as absolute and relative changes of antibody titers before and after third vaccination will be tested in univariate analyses (Spearman correlation for continuous variables such as age, time since last Covid-19 vaccination; chi-square for dichotomous variables such gender). Correlation of antibody titers before and after third vaccination will be calculated using Spearman correlation for the total group as well as separately for subgroups of interest (gender, categories of age, presence of certain comorbidities or concomitant medication) In multivariate regression analyses the impact of factors identified in univariate analyses on absolute titer as well as titer change will be assessed.;Timepoint(s) of evaluation of this end point: after 4 weeks and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety will be reported and evaluated for incidence and severity of adverse events (AE). Incidence rates will be performed in total as well as based on day of occurrence. Further, incidences will be weighted by participants self-reported severity. In secondary analyses, incidence rates will be compared between different subgroups of participants such as strategy of vaccination (homologous versus heterologous), categories of age or gender.;Timepoint(s) of evaluation of this end point: 1 week, 4 weeks and 6 months after vaccination | — |
Countries
Austria
Contacts
Public ContactClinical Trials Office
Medical University of Vienna
Outcome results
None listed