Vaccination; InfectionCoVaccNCT04920357
Immune Response to Vaccination Against Covid-19, a Follow up Study
An observational study of Vaccination; Infection and Covid19, run by Umeå University at 5 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, Covid19
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines
- How many people
- 3,000 participants
- Where
- 5 sitesSweden
- Study dates
- 31 Mar 2021to 31 Dec 2024
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.
Who may be able to join
- Consents to participate in the study
- Age ≥ 18 years
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Mälarsjukhuset
Eskilstuna, 633 49
Markus Kalén, MD, +46 (0)16-10 30 00, markus.kalen@regionsormland.se
- Recruiting
Karlstad Central hospital
Karlstad, 651 85
Staffan Tevell, PhD, +46 (0) 10-8315000, staffan.tevel@regionvarmland.se
- Recruiting
Örebro University hospital
Örebro, 701 85
Anja Rosdahl, MD, +46- (0)19-602 10 00, anja.rosdahl@regionorebrolan.se
- Recruiting
Östersund hospital
Östersund, 831 83
Micael Widerström, Assoc Prof, +46 (0)63-15 30 00, micael.widerstrom@umu.se
- Recruiting
Umeå University hospital
Umeå, 901 85
Johan Normark, Assoc Prof, +46- (0) 70-2258959, johan.normark@umu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaccination; Infection, Covid19
- Being tested
- Vaccination
- Keywords
- Immune response, Immunoglobulin G
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationDrug
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID-19 | Persons with a verified previous COVID-19 infection Receives: Drug: Vaccination | |
| COVID-19 naive | Persons that have no history of COVID-19 Receives: Drug: Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 and 6 months, 1, 2, 3, and 4 years after vaccination
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start31 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten, Värmland County Council, Sweden, Örebro Läns Landsting, Sormland County Council, Sweden, Region Jämtland Härjedalen
- Responsible party
- Sponsor
- Investigators
- Clas Ahlm, Prof, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920357
- Sponsor's protocol ID
- Eudra-CT2021-000683-30
- Acronym
- CoVacc
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
- ClinicalTrials.gov ID
- NCT04920357
- Acronym / sponsor ID
- CoVacc / Eudra-CT2021-000683-30
- Conditions
- Vaccination; Infection, Covid19
- Keywords
- Immune response, Immunoglobulin G
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten, Värmland County Council, Sweden, Örebro Läns Landsting, Sormland County Council, Sweden, Region Jämtland Härjedalen
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 | – | Drug: VaccinationPersons with a verified previous COVID-19 infection |
| COVID-19 naive | – | Drug: VaccinationPersons that have no history of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with and without pre-existing immunity to Covid-19 that are vaccinated in the national and regional vaccine campaign.
Key inclusion criteria (2 listed)
- Consents to participate in the study
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccinationPersons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study. | Drug | COVID-19 naive, Post-COVID-19 |
Primary outcome
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clas Ahlm, Prof principal investigator
Umeå University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination; Infection and Covid19, run by Umeå University at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clas Ahlm, Prof (+46-(0)70-3172965, clas.ahlm@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.