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

Sponsor

Lenanrt Friis-Hansen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04842305

Collaborator

(none)

500

Enrollment

35.4

Anticipated Duration (Months)

Study Details

Study Description

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	Phase
Covid19	Diagnostic Test: Blood- and saliva tests

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

Arm	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

Primary Outcome Measures

Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma [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

Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Lenanrt Friis-Hansen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 13, 2021

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lenanrt Friis-Hansen, Department of Clinical Biochemistry MD, DMSc, Principal Investigator, University Hospital Bispebjerg and Frederiksberg

sars-cov-2 antibodies

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 13, 2021