Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare With Regard to Vaccinations

Active, not recruiting

• Conditions: SARS-CoV 2
• Interventions: Diagnostic Test: SARS-CoV2 antibody measurement

• Registration Number: NCT04853004
• Lead Sponsor: Karolinska Institutet

Brief Summary

To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health \& disease, previous antibody responses and in relation to future disease occurring after vaccination.

Detailed Description

The purpose of the study is to analyze the effect of and possible side effects of SARS-CoV2 vaccinations in the cohort study where data on sick leave, SARS-Cov2 infections and SARS-CoV2 antibody levels are well documented even before vaccination.

The main outcome measures are the presence of SARS-CoV-2 (ongoing infection) and the presence of antibodies to SARS-CoV-2.

For the vaccination effect, the factors that are primarily associated with protection against infection are analyzed, such as age, sex, workplace, antibody response to SARS-CoV-2 and vaccination date.

The analyzes are planned to be performed with multivariate logistic regression with Relative Risk as the outcome measure.

Data from the analysis of virus antibodies are planned to be performed divided into whether low, medium or high levels of antibodies occur, with the same analysis for possible association with the factors listed above.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Primary Completion: 2023-03-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Study participant who agreed to be included in the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County".
• Study participant who has received or will receive vaccine against Covid-19 and who gives new written consent to the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to vaccinations".

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Exclusion Criteria

• those who have not given informed consent to participate in the study In this study, no initiative is taken for vaccination. The vaccinations are carried out by the healthcare system and of course follow the established exclusion and inclusion criteria for the approved vaccines. All persons who have received the vaccine and who give written consent are eligible to be included in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	SARS-CoV2 antibody measurement	Personnel in health and care in Stockholm County, who have previously participated in a study where data on sick leave, SARS-Cov2 infections and SARS-CoV2 antibody levels were collected and documented form the study cohort.

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 infection	24 months post primary vaccination	Characterized by whether they are asymptomatic infections or sick leave-requiring infections.

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 antibody induction	24 months post primary vaccination	Antibodies will be characterized in terms of antibody levels, which SARS-CoV-2 antigen to which the response is directed and whether the antibodies are protective or not.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden