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OpenTrials
Active, Not Recruiting

NCT Number: NCT04853004

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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".

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.

Treatment and study plan

SARS-CoV2 antibody measurement

Diagnostic Test

Blood samples for serology, collected immediately prior to and five to ten weeks after vaccination against SARS-CoV2, to be analyzed for the presence of SARS-CoV-2 antibodies.

Primary outcomes

  1. SARS-CoV-2 infection

    Time frame: 24 months post primary vaccination

    Characterized by whether they are asymptomatic infections or sick leave-requiring infections.

Secondary outcomes

  1. SARS-CoV-2 antibody induction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

Studies of Ongoing and Completed SARS-CoV-2 Infection (Which Causes COVID-19) Within the Healthcare in Stockholm County, With Regard to Vaccinations.

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Apr 21, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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