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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04920357
Other study ID # Eudra-CT2021-000683-30
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 31, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2021
Source Umeå University
Contact Clas Ahlm, Prof
Phone +46-(0)70-3172965
Email clas.ahlm@umu.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response. The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.


Description:

The main objective is to investigate if the antibody development to SARS-CoV-2 S protein differ after vaccination in those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals. The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups. Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign. The study includes all approved COVID-19 vaccines with marketing authorization in Sweden. Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response. Data on sex, age, body mass index, medical history and concomitant medication is collected. The study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at UmeƄ University Hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 31, 2024
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consents to participate in the study - Age = 18 years Exclusion Criteria: - Age <18 years - Incapable of giving informed consent - Contraindication to vaccination - Severe disease - Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids > 15 mg orally per day.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.

Locations

Country Name City State
Sweden Mälarsjukhuset Eskilstuna
Sweden Karlstad Central hospital Karlstad
Sweden Örebro University hospital Örebro
Sweden Östersund hospital Östersund
Sweden Umeå University hospital Umeå

Sponsors (6)

Lead Sponsor Collaborator
Umeå University Örebro Läns Landsting, Region Jämtland Härjedalen, Region Västerbotten, Sormland County Council, Sweden, Värmland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time. Levels of specific IgG antibody against SARS-CoV-2 will be measured as optical density, OD in a specific Spike-protein IgG ELISA at each time-point. 1 and 6 months, 1, 2, 3, and 4 years after vaccination.
Primary Change in proportion of participants with detectable specific IgG antibodies after vaccination over time. Immune response will be measured as the proportion of participants (in % of all vaccinated individuals) with detectable specific IgG antibodies after vaccination at each time-point (in months after vaccination). 1 and 6 months, 1, 2, 3, and 4 years after vaccination
Secondary Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals. Levels of markers for cellular and serological immune response after COVID-19 vaccination e.g. specific antibodies, T- and B-cell memory. Change of markers for cellular and serological immune response over time measured at 1 and 6 months, 1, 2, 3, and 4 years after vaccination
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