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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Vaccination; Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Clas Ahlm, Prof; Phone Number: +46-(0)70-3172965; Email: clas.ahlm@umu.se
• Study Contact Backup: Name: Mattias Forsell, Assoc Prof; Phone Number: +46-(0)73-0211221; Email: mattias.forsell@umu.se

Study Locations

• Sweden
  • Eskilstuna, Sweden, 633 49
    • Recruiting
    • Mälarsjukhuset
    • Contact: Markus Kalén, MD; Phone Number: +46 (0)16-10 30 00; Email: markus.kalen@regionsormland.se
  • Karlstad, Sweden, 651 85
    • Recruiting
    • Karlstad Central Hospital
    • Contact: Staffan Tevell, PhD; Phone Number: +46 (0) 10-8315000; Email: staffan.tevel@regionvarmland.se
  • Umeå, Sweden, 901 85
    • Recruiting
    • Umeå University Hospital
    • Contact: Johan Normark, Assoc Prof; Phone Number: +46- (0) 70-2258959; Email: johan.normark@umu.se
  • Örebro, Sweden, 701 85
    • Recruiting
    • Örebro University Hospital
    • Contact: Anja Rosdahl, MD; Phone Number: +46- (0)19-602 10 00; Email: anja.rosdahl@regionorebrolan.se
  • Östersund, Sweden, 831 83
    • Recruiting
    • Östersund Hospital
    • Contact: Micael Widerström, Assoc Prof; Phone Number: +46 (0)63-15 30 00; Email: micael.widerstrom@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Värmland County Council, Sweden; Region Västerbotten; Örebro Läns Landsting; Region Jämtland Härjedalen; Sormland County Council, Sweden
• Investigators: Principal Investigator: Clas Ahlm, Prof, Umeå University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2021
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (ACTUAL): June 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Immune response; Immunoglobulin G
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Eudra-CT2021-000683-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No