Immune Response to Vaccination Against Covid-19, a Follow up Study

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.

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.

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.