Severe Acute Respiratory Syndrome Coronavirus 2 Re-Infection Risk and Vaccine Efficacy in Austria

COVID-19 Clinical Trial

— SARIVA  

Official title:

SARS-CoV-2 Re-Infection Risk and Vaccine Efficacy in Austria: SARIVA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06162533
• Other study ID #: SARIVA 1.0.
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The coronavirus disease 2019 (COVID-19) pandemic was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. In this study, we aim to evaluate how strong and how long are individuals in Austria after vaccination and/or infection with SARS-CoV-2 protected against COVID-19 disease.

In this project, we will analyze national health data from all inhabitants of Austria (about 9 million persons) during the COVID-19 pandemic. The population of Austria will be stratified into different groups according to previous vaccinations against SARS-CoV-2 and previous SARS-CoV-2 infections.

We primarily evaluate how strong and how long after vaccination against SARS-CoV-2 and/or infection with SARS-CoV-2, the risk for COVID-19 deaths is reduced or altered as compared to less vaccinated and/or infected persons. As secondary study aims, we perform such analyses also for SARS-CoV-2 infections, hospitalizations and intensive care unit (ICU) stays, with or due to SARS-CoV-2. These analyses will be performed during different time periods of the COVID-19 pandemic, and we will also perform various subgroup analyses as for example according to age and gender. Given that antibodies against SARS-CoV-2 are usually detected after vaccination and/or infection, we will use such antibody data from blood donors in Tyrol, to elucidate how well the national health data on SARS-CoV-2 infections and vaccinations match with the respective antibody data, and how well these antibody data indicate risk of COVID-19 deaths and infections.

We will calculate the probability of dying due to a SARS-CoV-2 infection (case/infection fatality rate) for different times of the COVID-19 pandemic, in order to document the health threat due to SARS-CoV-2. Based on all these data, we will calculate how many persons have to be vaccinated against SARS-CoV-2 to prevent one COVID-19 death at different times during this COVID-19 pandemic. We will consider the respective COVID-19 policies such as mask mandates, lock-downs, SARS-CoV-2 test mandates in our analyses and will evaluate the impact of these policies on COVID-19 deaths and diseases. In addition, we will evaluate data on total mortality according to the number of SARS-CoV-2 vaccinations and/or infections, and we will aim to collaborate with other research groups in order to extend our analyses.

In conclusion, the results of this study should provide an overview on the COVID-19 pandemic with respect to protection conferred by vaccinations and previous SARS-CoV-2 infections, as well as the health threat of SARS-CoV-2, in order to provide knowledge for future COVID-19 policy and future pandemics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9090868
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residency in Austria.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Vaccination against SARS-CoV-2
Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Medical University of Innsbruck	Innsbruck
Austria	Austrian Agency for Health and Food Safety	Vienna

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of Graz	AGES, Austrian Science Fund (FWF), Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 death	Death due to COVID-19	January 1, 2000 to June 30, 2023
Secondary	SARS-CoV-2 infection	Documented SARS-CoV-2 infection	January 1, 2000 to June 30, 2023
Secondary	ICU stay	ICU stay of COVID-19 patients	January 1, 2000 to June 30, 2023
Secondary	Hospitalization	Hospitalization of COVID-19 patients	January 1, 2000 to June 30, 2023
Secondary	All-cause mortality	Death due to all-causes	January 1, 2000 to June 30, 2023