Clinical trial NCT04920357: Immune Response to Vaccination Against Covid-19, a Follow up Study
Official title: CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccination; Infection
Covid19
Keywords: Immune response
Immunoglobulin G
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
name: Värmland County Council, Sweden
name: Örebro Läns Landsting
name: Sormland County Council, Sweden
name: Region Jämtland Härjedalen
First posted: 2021-06-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time.
timeFrame: 1 and 6 months, 1, 2, 3, and 4 years after vaccination.
measure: Change in proportion of participants with detectable specific IgG antibodies after vaccination over time.
timeFrame: 1 and 6 months, 1, 2, 3, and 4 years after vaccination
Secondary outcomes:
measure: Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals.
timeFrame: 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
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Karlstad
country: Sweden
facility: Karlstad Central hospital
city: Umeå
country: Sweden
facility: Umeå University hospital
city: Örebro
country: Sweden
facility: Örebro University hospital
city: Östersund
country: Sweden
facility: Östersund hospital
Study officials:
affiliation: Umeå University
name: Clas Ahlm, Prof
role: PRINCIPAL_INVESTIGATOR
References: