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

NCT06162533 | Completed

• 1 other identifier: SARIVA 1.0.
• Study Type: observational
• Target: 9,090,868
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• COVID-19 death

  Death due to COVID-19

  January 1, 2000 to June 30, 2023

Secondary Outcomes (4)

• SARS-CoV-2 infection

  January 1, 2000 to June 30, 2023

• ICU stay

  January 1, 2000 to June 30, 2023

• Hospitalization

  January 1, 2000 to June 30, 2023

• All-cause mortality

  January 1, 2000 to June 30, 2023

Study Arms (4)

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

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

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.

Interventions

Vaccination against SARS-CoV-2 BIOLOGICAL

Interventions are either a vaccination against SARS-CoV-2 or an infection with SARS-CoV-2

Also known as: Infection with SARS-CoV-2

Hybrid Immunity against SARS-CoV-2; Vaccinated against SARS-CoV-2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The national population of Austria

You may qualify if:

• \- Residency in Austria.

You may not qualify if:

• \- None.

Sponsors & Collaborators

• Medical University of Graz: lead
• AGES: collaborator
• Medical University Innsbruck: collaborator
• Austrian Science Fund (FWF): collaborator

Study Sites (3)

Medical University of Graz

Graz, 8036, Austria

Location

Medical University of Innsbruck

Innsbruck, Austria

Location

Austrian Agency for Health and Food Safety

Vienna, Austria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

AU (3)