Covid19COVID19vac-1NCT04706390
Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
An observational study of Covid19, run by University of Bergen at 1 site in Norway.
Trial summary
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Read more about this study
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 20 to 100 years
- All sexes
- Adult, Older adult
Study population: Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.
Who may be able to join
- subjects prioritized by national vaccination program
Who cannot join
- Children
- unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University of Bergen
Bergen, 5020
Rebecca J Cox, PhD, 45242974, rebecca.cox@uib.no
Nina Langeland, MD, 41616450, nina.langeland@uib.no
About this study
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.
Read the detailed description
The primary aim of this study is
- To compare immune responses after natural SARS-CoV-2 infection and COVID-19 vaccination The secondary aims are
- To compare the duration and breadth of antibody responses between natural infection and vaccination.
- To investigate the duration and breadth of B and T cellular responses between natural infection and vaccination.
- To evaluate the short and long term complications after natural infection and vaccination.
- To find out if previous infection skews the immune response after vaccination.
- To study reinfection after natural infection and vaccination.
- Conditions
- Covid19
- Being tested
- covid-19 vaccine
- Keywords
- Covid19, Vaccine, SARS-CoV-2 antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid-19 vaccineBiological
vaccination
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | 500-1000 health care workers prioritized for early vaccination Receives: Biological: covid-19 vaccine | |
| prioritized patient populations | 2000 individuals in patient populations prioritized for vaccinations Receives: Biological: covid-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune responses
spike antibody response to SARS-CoV-2
Measured: 2 months to 3 years
Secondary outcomes (2)
Duration and breadth of B- cell responses
compare serological and memory B cells after vaccination to natural infection
Measured: 2 months to 3 years
Duration and breadth of T cell responses
compare T cell responses after vaccination to natural infection
Measured: 2 months to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start12 Jan 2021
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Rebecca Cox, University of Bergen
- Investigators
- Rebecca J Cox, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706390
- Sponsor's protocol ID
- COVID-19vacc-1
- Acronym
- COVID19vac-1
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be developed
Publications
Cox RJ, Brokstad KA, Krammer F, Langeland N; Bergen COVID-19 Research Group. Seroconversion in household members of COVID-19 outpatients. Lancet Infect Dis. 2021 Feb;21(2):168. doi: 10.1016/S1473-3099(20)30466-7. Epub 2020 Jun 15. No abstract available.
PubMed 32553187Trieu MC, Bansal A, Madsen A, Zhou F, Saevik M, Vahokoski J, Brokstad KA, Krammer F, Tondel C, Mohn KGI, Blomberg B, Langeland N, Cox RJ; Bergen COVID-19 Research Group. SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study. J Infect Dis. 2021 Feb 24;223(4):589-599. doi: 10.1093/infdis/jiaa737.
PubMed 33247924Bredholt G, Saevik M, Soyland H, Ueland T, Zhou F, Pathirana R, Madsen A, Vahokoski J, Lartey S, Halvorsen BE, Dahl TB, Trieu MC, Mohn KG, Brokstad KA, Aukrust P, Tondel C, Langeland N, Blomberg B, Cox RJ; Bergen COVID-19 Research Group. Three doses of Sars-CoV-2 mRNA vaccine in older adults result in similar antibody responses but reduced cellular cytokine responses relative to younger adults. Vaccine X. 2024 Sep 25;20:100564. doi: 10.1016/j.jvacx.2024.100564. eCollection 2024 Oct.
PubMed 39403561Hansen L, Brokstad KA, Bansal A, Zhou F, Bredholt G, Onyango TB, Sandnes HH, Elyanow R, Madsen A, Trieu MC, Saevik M, Soyland H, Olofsson JS, Vahokoski J, Ertesvag NU, Fjelltveit EB, Shafiani S, Tondel C, Chapman H, Kaplan I, Mohn KGI, Langeland N, Cox RJ. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults. Vaccine X. 2023 Apr;13:100262. doi: 10.1016/j.jvacx.2023.100262. Epub 2023 Jan 10.
PubMed 36643855
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination
- ClinicalTrials.gov ID
- NCT04706390
- Acronym / sponsor ID
- COVID19vac-1 / COVID-19vacc-1
- Conditions
- Covid19
- Keywords
- Covid19, Vaccine, SARS-CoV-2 antibody
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Dec 2030 (estimated)
- First posted
- 12 Jan 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 ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.
Detailed description
The primary aim of this study is
- To compare immune responses after natural SARS-CoV-2 infection and COVID-19 vaccination The secondary aims are
- To compare the duration and breadth of antibody responses between natural infection and vaccination.
- To investigate the duration and breadth of B and T cellular responses between natural infection and vaccination.
- To evaluate the short and long term complications after natural infection and vaccination.
- To find out if previous infection skews the immune response after vaccination.
- To study reinfection after natural infection and vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Biological: covid-19 vaccine500-1000 health care workers prioritized for early vaccination |
| prioritized patient populations | – | Biological: covid-19 vaccine2000 individuals in patient populations prioritized for vaccinations |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.
Key inclusion criteria (1 listed)
- subjects prioritized by national vaccination program
Key exclusion criteria (2 listed)
- Children
- unable or unwilling to provide informed consent
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 |
|---|---|---|
| covid-19 vaccinevaccination | Biological | Health care workers, prioritized patient populations |
Primary outcome
immune responses
Time frame: 2 months to 3 years
spike antibody response to SARS-CoV-2
2 secondary outcomes
Duration and breadth of B- cell responses
Time frame: 2 months to 3 years
Duration and breadth of T cell responses
Time frame: 2 months to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 32553187Cox RJ, Brokstad KA, Krammer F, Langeland N; Bergen COVID-19 Research Group. Seroconversion in household members of COVID-19 outpatients. Lancet Infect Dis. 2021 Feb;21(2):168. doi: 10.1016/S1473-3099(20)30466-7. Epub 2020 Jun 15. No abstract available.
- Background: PubMed 33247924Trieu MC, Bansal A, Madsen A, Zhou F, Saevik M, Vahokoski J, Brokstad KA, Krammer F, Tondel C, Mohn KGI, Blomberg B, Langeland N, Cox RJ; Bergen COVID-19 Research Group. SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study. J Infect Dis. 2021 Feb 24;223(4):589-599. doi: 10.1093/infdis/jiaa737.
- Derived from this study: PubMed 39403561Bredholt G, Saevik M, Soyland H, Ueland T, Zhou F, Pathirana R, Madsen A, Vahokoski J, Lartey S, Halvorsen BE, Dahl TB, Trieu MC, Mohn KG, Brokstad KA, Aukrust P, Tondel C, Langeland N, Blomberg B, Cox RJ; Bergen COVID-19 Research Group. Three doses of Sars-CoV-2 mRNA vaccine in older adults result in similar antibody responses but reduced cellular cytokine responses relative to younger adults. Vaccine X. 2024 Sep 25;20:100564. doi: 10.1016/j.jvacx.2024.100564. eCollection 2024 Oct.
- Derived from this study: PubMed 36643855Hansen L, Brokstad KA, Bansal A, Zhou F, Bredholt G, Onyango TB, Sandnes HH, Elyanow R, Madsen A, Trieu MC, Saevik M, Soyland H, Olofsson JS, Vahokoski J, Ertesvag NU, Fjelltveit EB, Shafiani S, Tondel C, Chapman H, Kaplan I, Mohn KGI, Langeland N, Cox RJ. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults. Vaccine X. 2023 Apr;13:100262. doi: 10.1016/j.jvacx.2023.100262. Epub 2023 Jan 10.
- Individual participant dataSharing planned: Undecided. To be developed
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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.
Rebecca J Cox, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Bergen at 1 site in Norway.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca J Cox, PhD (+4745242974, rebecca.cox@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune responses (time frame: 2 months to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706390, which also lists 4 linked publications.
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 19 Apr 2024.