Karolinska University Hospital
Stockholm, 141 86, Sweden
NCT Number: NCT04853004
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–99 year
All sexes
Observational
Stockholm, 141 86, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 months post primary vaccination
Characterized by whether they are asymptomatic infections or sick leave-requiring infections.
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.
Karolinska Institutet
Other
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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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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