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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Vaccination against SARS-CoV-2

• Study Type: Observational
• Enrollment (Actual): 9090868

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz
  • Innsbruck, Austria
    • Medical University of Innsbruck
  • Vienna, Austria
    • Austrian Agency for Health and Food Safety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The national population of Austria

Description

Inclusion Criteria:

- Residency in Austria.

Exclusion Criteria:

- None.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccinated against SARS-CoV-2; Individuals who received a SARS-CoV-2 vaccine but have no record of a previous SARS-CoV-2 infection. Subgroups will be formed according to the number and type of vaccines against SARS-CoV-2.	Biological: Vaccination against SARS-CoV-2; Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2; Other Names: Infection with SARS-CoV-2
Previously SARS-CoV-2 infected; Individuals who were previously infected with SARS-CoV-2 but have not received a SARS-CoV-2 vaccine. Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections.
Hybrid Immunity against SARS-CoV-2; Individuals who received a SARS-CoV-2 vaccine and who were previously infected with SARS-CoV-2. Subgroups will be formed according to the number and time period of previous SARS-CoV-2 infections, the number and type of vaccines against SARS-CoV-2, and according to whether the vaccination or the infection was the first immune conferring event.	Biological: Vaccination against SARS-CoV-2; Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2; Other Names: Infection with SARS-CoV-2
No immunity against SARS-CoV-2; Individuals who have not received a SARS-CoV-2 vaccine and were not previously infected with SARS-CoV-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 death	Death due to COVID-19	January 1, 2000 to June 30, 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection	Documented SARS-CoV-2 infection	January 1, 2000 to June 30, 2023
ICU stay	ICU stay of COVID-19 patients	January 1, 2000 to June 30, 2023
Hospitalization	Hospitalization of COVID-19 patients	January 1, 2000 to June 30, 2023
All-cause mortality	Death due to all-causes	January 1, 2000 to June 30, 2023

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Medical University Innsbruck; Austrian Science Fund (FWF); AGES

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Reinfection
• Other Study ID Numbers: SARIVA 1.0.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual participant data of this study are available upon request with approval needed from the Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, and an ethical approval or waiver by the local ethic committee for use of these data. The individual participant data are not publicly available due to restrictions pertaining to contained information that could compromise the privacy of individuals (i.e. potentially allow the identification of certain individuals based on e.g. birthdate, gender and infection or death date). Data are stored at the AGES. The same data availability rules apply to the antibody data (i.e. Anti-SARS-CoV-2 antibodies) from the Medical University of Innsbruck.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No