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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

Tracking Information
First Submitted Date May 31, 2021
First Posted Date June 9, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date March 31, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2021)
  • 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.
  • 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 8, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 4 Years
Biospecimen Retention:   Samples With DNA
Description:
Periferal blood mononuclear cells (PBMC), plasma and sera.
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.
Condition
  • Vaccination; Infection
  • Covid19
Intervention Drug: Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
Study Groups/Cohorts
  • Post-COVID-19
    Persons with a verified previous COVID-19 infection
    Intervention: Drug: Vaccination
  • COVID-19 naive
    Persons that have no history of COVID-19
    Intervention: Drug: Vaccination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 8, 2021)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04920357
Other Study ID Numbers Eudra-CT2021-000683-30
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Umeå University
Study Sponsor Umeå University
Collaborators
  • Region Västerbotten
  • Värmland County Council, Sweden
  • Örebro Läns Landsting
  • Sormland County Council, Sweden
  • Region Jämtland Härjedalen
Investigators
Principal Investigator: Clas Ahlm, Prof Umeå University
PRS Account Umeå University
Verification Date June 2021