Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842305
Recruitment Status : Not yet recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Lenanrt Friis-Hansen, University Hospital Bispebjerg and Frederiksberg

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Blood- and saliva tests

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : March 15, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
G1: Control group
SARS-CoV-2 naïve persons who have neither been vaccinated nor have had COVID-19 (controls)
 Diagnostic Test: Blood- and saliva tests
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
G2: COVID-19 infected
Persons who have had COVID-19
 Diagnostic Test: Blood- and saliva tests
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
G3: COVID-19 vaccinated
Persons who have been vaccinated with Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1-S
 Diagnostic Test: Blood- and saliva tests
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
G4: COVID-19 infected and vaccinated
Individuals who have been infected with COVID-19 and subsequently been vaccinated
 Diagnostic Test: Blood- and saliva tests
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma [ Time Frame: Between 21 and 200 days after vaccination ]
    Comparison of SARS-CoV-2 spike glycoprotein RBD antibodies (in saliva and plasma) between participants vaccinated with Pfizer-BioNTech, Moderna mRNA-1273 and AstraZeneca


Biospecimen Retention:   Samples With DNA
Blood and saliva

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Written informed consent
  • Both Hospital staff as well as non-health care workers will be invited to participate

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842305


Contacts
Layout table for location contacts
Contact: Lennart Friis-Hansen, Dr.med. 61145916 lennart.jan.friis-hansen@regionh.dk

Sponsors and Collaborators
Lenanrt Friis-Hansen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lenanrt Friis-Hansen, Department of Clinical Biochemistry MD, DMSc, Principal Investigator, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04842305    
Other Study ID Numbers: P-2021-224
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lenanrt Friis-Hansen, University Hospital Bispebjerg and Frederiksberg:
sars-cov-2 antibodies
saliva
mucosal immunity
 vaccination
covid19
spike glycoprotein
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases