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| Name | Class |
|---|---|
| Region Västerbotten | OTHER_GOV |
| Värmland County Council, Sweden | OTHER_GOV |
| Örebro Läns Landsting | OTHER_GOV |
| Sormland County Council, Sweden |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-COVID-19 | Persons with a verified previous COVID-19 infection |
| |
| COVID-19 naive | Persons that have no history of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination | Drug | Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clas Ahlm, Prof | Contact | +46-(0)70-3172965 | clas.ahlm@umu.se | |
| Mattias Forsell, Assoc Prof | Contact | +46-(0)73-0211221 | mattias.forsell@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Clas Ahlm, Prof | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mälarsjukhuset | Recruiting | Eskilstuna | 633 49 | Sweden |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
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| OTHER |
| Region Jämtland Härjedalen | OTHER |
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Periferal blood mononuclear cells (PBMC), plasma and sera.
| Karlstad Central hospital | Recruiting | Karlstad | 651 85 | Sweden |
|
| Örebro University hospital | Recruiting | Örebro | 701 85 | Sweden |
|
| Östersund hospital | Recruiting | Östersund | 831 83 | Sweden |
|
| Umeå University hospital | Recruiting | Umeå | 901 85 | Sweden |
|
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |