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

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ClinicalTrials.gov Identifier: NCT04920357
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 9, 2021
Sponsor:
Collaborators:
Region Västerbotten
Värmland County Council, Sweden
Örebro Läns Landsting
Sormland County Council, Sweden
Region Jämtland Härjedalen
Information provided by (Responsible Party):
Umeå University

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.


Condition or disease Intervention/treatment
Vaccination; Infection Covid19 Drug: 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2024

Group/Cohort Intervention/treatment
Post-COVID-19
Persons with a verified previous COVID-19 infection
Drug: Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.

COVID-19 naive
Persons that have no history of COVID-19
Drug: Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.




Primary Outcome Measures :
  1. Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time. [ Time Frame: 1 and 6 months, 1, 2, 3, and 4 years after vaccination. ]
    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.

  2. Change in proportion of participants with detectable specific IgG antibodies after vaccination over time. [ Time Frame: 1 and 6 months, 1, 2, 3, and 4 years after vaccination ]
    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).


Secondary Outcome Measures :
  1. Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals. [ 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 ]
    Levels of markers for cellular and serological immune response after COVID-19 vaccination e.g. specific antibodies, T- and B-cell memory.


Biospecimen Retention:   Samples With DNA
Periferal blood mononuclear cells (PBMC), plasma and sera.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920357


Contacts
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Contact: Clas Ahlm, Prof +46-(0)70-3172965 clas.ahlm@umu.se
Contact: Mattias Forsell, Assoc Prof +46-(0)73-0211221 mattias.forsell@umu.se

Locations
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Sweden
Mälarsjukhuset Recruiting
Eskilstuna, Sweden, 633 49
Contact: Markus Kalén, MD    +46 (0)16-10 30 00    markus.kalen@regionsormland.se   
Karlstad Central hospital Recruiting
Karlstad, Sweden, 651 85
Contact: Staffan Tevell, PhD    +46 (0) 10-8315000    staffan.tevel@regionvarmland.se   
Umeå University hospital Recruiting
Umeå, Sweden, 901 85
Contact: Johan Normark, Assoc Prof    +46- (0) 70-2258959    johan.normark@umu.se   
Örebro University hospital Recruiting
Örebro, Sweden, 701 85
Contact: Anja Rosdahl, MD    +46- (0)19-602 10 00    anja.rosdahl@regionorebrolan.se   
Östersund hospital Recruiting
Östersund, Sweden, 831 83
Contact: Micael Widerström, Assoc Prof    +46 (0)63-15 30 00    micael.widerstrom@umu.se   
Sponsors and Collaborators
Umeå University
Region Västerbotten
Värmland County Council, Sweden
Örebro Läns Landsting
Sormland County Council, Sweden
Region Jämtland Härjedalen
Investigators
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Principal Investigator: Clas Ahlm, Prof Umeå University
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT04920357    
Other Study ID Numbers: Eudra-CT2021-000683-30
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umeå University:
Immune response
Immunoglobulin G
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs