Covid19NCT04842305
Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination
An observational study of Covid19, run by Lenanrt Friis-Hansen.
Trial summary
The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Blood- and saliva tests
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to 15 Mar 2024
- 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 who belong to one of the following four groups will be included G1=SARS-COV-2 Naïve (=Not SARS-CoV-2 vaccinated and COVID-19 negative), G2=COVID-19 convalescents, G3=Vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine, G4=COVID-19 positive and vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine
Who may be able to join
- Written informed consent
- Both Hospital staff as well as non-health care workers will be invited to participate
Who cannot join
- Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
- Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination
The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.
- Conditions
- Covid19
- Being tested
- Blood- and saliva tests
- Keywords
- sars-cov-2 antibodies, saliva, mucosal immunity, vaccination, covid19, spike glycoprotein
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood- and saliva testsDiagnostic test
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
| Study group | Role | What they receive |
|---|---|---|
| G1: Control group | SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls) Receives: Diagnostic Test: Blood- and saliva tests | |
| G2: COVID-19 infected | Persons who have had COVID-19 Receives: Diagnostic Test: Blood- and saliva tests | |
| G3: COVID-19 vaccinated | Persons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S Receives: Diagnostic Test: Blood- and saliva tests | |
| G4: COVID-19 infected and vaccinated | Individuals who have been infected with COVID-19 and subsequently been vaccinated Receives: Diagnostic Test: Blood- and saliva tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
Detection of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma in participants who have been infected with COVID-19, vaccinated with Pfizer-BioNTech/Moderna mRNA-1273/AstraZeneca or infected and vaccinated
Measured: Between 21 and 200 days after infection/vaccination
Secondary outcomes (1)
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
Comparison of SARS-CoV-2 spike glycoprotein RBD antibodies (in saliva and plasma) between participants vaccinated with Pfizer-BioNTech, Moderna mRNA-1273 and AstraZeneca
Measured: Between 21 and 200 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenanrt Friis-Hansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lenanrt Friis-Hansen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842305
- Sponsor's protocol ID
- P-2021-224
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination
- ClinicalTrials.gov ID
- NCT04842305
- Acronym / sponsor ID
- P-2021-224
- Conditions
- Covid19
- Keywords
- sars-cov-2 antibodies, saliva, mucosal immunity, vaccination, covid19, spike glycoprotein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lenanrt Friis-HansenUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 13 Apr 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 Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1: Control group | – | Diagnostic Test: Blood- and saliva testsSARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls) |
| G2: COVID-19 infected | – | Diagnostic Test: Blood- and saliva testsPersons who have had COVID-19 |
| G3: COVID-19 vaccinated | – | Diagnostic Test: Blood- and saliva testsPersons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S |
| G4: COVID-19 infected and vaccinated | – | Diagnostic Test: Blood- and saliva testsIndividuals who have been infected with COVID-19 and subsequently been vaccinated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who belong to one of the following four groups will be included G1=SARS-COV-2 Naïve (=Not SARS-CoV-2 vaccinated and COVID-19 negative), G2=COVID-19 convalescents, G3=Vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine, G4=COVID-19 positive and vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S vaccine
Key inclusion criteria (2 listed)
- Written informed consent
- Both Hospital staff as well as non-health care workers will be invited to participate
Key exclusion criteria (2 listed)
- Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
- Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.
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 |
|---|---|---|
| Blood- and saliva testsMeasurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva | Diagnostic test | G1: Control group, G2: COVID-19 infected, G3: COVID-19 vaccinated, G4: COVID-19 infected and vaccinated |
Primary outcome
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
Time frame: Between 21 and 200 days after infection/vaccination
Detection of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma in participants who have been infected with COVID-19, vaccinated with Pfizer-BioNTech/Moderna mRNA-1273/AstraZeneca or infected and vaccinated
1 secondary outcome
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma
Time frame: Between 21 and 200 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Lenanrt Friis-Hansen.
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 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Lennart Friis-Hansen, Dr.med. (61145916, lennart.jan.friis-hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma (time frame: Between 21 and 200 days after infection/vaccination). 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 13 Apr 2021.