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

NCT04853004 | Active Not Recruiting

• 1 other identifier: Covid19_7
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

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

  24 months post primary vaccination

Secondary Outcomes (1)

• SARS-CoV-2 antibody induction

  24 months post primary vaccination

Study Arms (1)

Study cohort

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.

Diagnostic Test: SARS-CoV2 antibody measurement

Interventions

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.

Study cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-Personnel within healthcare in Stockholm County who have previously participated in a study on SARS-CoV-2 infection within healthcare in Stockholm County and who are offered a vaccine against Covid-19.

You may qualify if:

• 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".

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Officials

• Joakim Dillner, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 21, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

SE (1)