Immune Response to Vaccination Against Covid-19, a Follow up Study
- Conditions
- Covid19Vaccination; Infection
- Interventions
- Drug: Vaccination
- Registration Number
- NCT04920357
- Lead Sponsor
- Umeå University
- Brief 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.
- Detailed 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 Umeå University Hospital.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- Consents to participate in the study
- Age ≥ 18 years
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post-COVID-19 Vaccination Persons with a verified previous COVID-19 infection COVID-19 naive Vaccination Persons that have no history of COVID-19
- Primary Outcome Measures
Name Time Method Change in proportion of participants with detectable specific IgG antibodies after vaccination over time. 1 and 6 months, 1, 2, 3, and 4 years after vaccination 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).
Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time. 1 and 6 months, 1, 2, 3, and 4 years after vaccination. 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.
- Secondary Outcome Measures
Name Time Method Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals. 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 Levels of markers for cellular and serological immune response after COVID-19 vaccination e.g. specific antibodies, T- and B-cell memory.
Trial Locations
- Locations (5)
Umeå University hospital
🇸🇪Umeå, Sweden
Mälarsjukhuset
🇸🇪Eskilstuna, Sweden
Östersund hospital
🇸🇪Östersund, Sweden
Örebro University hospital
🇸🇪Örebro, Sweden
Karlstad Central hospital
🇸🇪Karlstad, Sweden