Covid19 Clinical Trial
— CoVaccOfficial title:
CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Örebro Läns Landsting, Region Jämtland Härjedalen, Region Västerbotten, Sormland County Council, Sweden, Värmland County Council, Sweden |
Sweden,
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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