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NCT04842305 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04842305
Other study ID # P-2021-224
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date March 15, 2024

Study information
Verified date April 2021
Source University Hospital Bispebjerg and Frederiksberg
Contact Lennart Friis-Hansen, Dr.med.
Phone 61145916
Email lennart.jan.friis-hansen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date March 15, 2024
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood- and saliva tests
Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Lenanrt Friis-Hansen

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Between 21 and 200 days after infection/vaccination
Secondary 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 Between 21 and 200 days after vaccination
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