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

Covid19 Clinical Trial

— CoVacc  

Official title:

CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920357
• Other study ID #: Eudra-CT2021-000683-30
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2021
• Source: Umeå University
• Contact: Clas Ahlm, Prof
• Phone: +46-(0)70-3172965
• Email: clas.ahlm[@]umu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Vaccination; Infection

Intervention

Drug:
• Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset	Eskilstuna
Sweden	Karlstad Central hospital	Karlstad
Sweden	Örebro University hospital	Örebro
Sweden	Östersund hospital	Östersund
Sweden	Umeå University hospital	Umeå

Sponsors (6)

Lead Sponsor	Collaborator
Umeå University	Örebro Läns Landsting, Region Jämtland Härjedalen, Region Västerbotten, Sormland County Council, Sweden, Värmland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Secondary	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