NCT04842305

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

April 5, 2021

Last Update Submit

April 12, 2021

Conditions

Covid19

Keywords

sars-cov-2 antibodiessalivamucosal immunityvaccinationcovid19spike glycoprotein

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Between 21 and 200 days after vaccination

Study Arms (4)

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

G2: COVID-19 infected

Persons who have had COVID-19

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

Diagnostic Test: Blood- and saliva tests

G4: COVID-19 infected and vaccinated

Individuals who have been infected with COVID-19 and subsequently been vaccinated

Diagnostic Test: Blood- and saliva tests

Interventions

Blood- and saliva testsDIAGNOSTIC_TEST

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

G1: Control groupG2: COVID-19 infectedG3: COVID-19 vaccinatedG4: COVID-19 infected and vaccinated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Lennart Friis-Hansen, Dr.med.

CONTACT

61145916lennart.jan.friis-hansen@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Clinical Biochemistry MD, DMSc, Principal Investigator

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 13, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2021

Study Completion

March 15, 2024

Last Updated

April 13, 2021

Record last verified: 2021-04