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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
Mälarsjukhuset
Eskilstuna, Sweden
RECRUITINGKarlstad Central hospital
Karlstad, Sweden
RECRUITINGÖrebro University hospital
Örebro, Sweden
RECRUITINGChange 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.
Time frame: 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).
Time frame: 1 and 6 months, 1, 2, 3, and 4 years after vaccination
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.
Time frame: 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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Östersund hospital
Östersund, Sweden
RECRUITINGUmeå University hospital
Umeå, Sweden
RECRUITING