Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines (CoVVacBoost)

Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines - The CoVVacBoost Study

The investigators aim to evaluate the ability of a COVID-19 (Coronavirus disease) booster vaccine to induce a salivary antibody response and investigate a possible correlation with the serum antibody response and the cellular response.

The investigators will conduct a prospective single center cohort study including fully vaccinated probands.

Study Overview

• Status: Terminated
• Conditions: Anti-SARS-CoV-2 Antibody Response
• Intervention / Treatment: Procedure: blood and saliva samples will be taken

Detailed Description

The investigators will conduct a prospective single center cohort study including fully vaccinated probands.. The study will take place at the Medical University of Graz. Blood and saliva samples will be obtained before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination.

The total duration of the study is 15 months, starting in November 2021 with a recruiting period until June 2022 and termination of all scheduled visits until January 2023.

In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent).Scheduled vaccination for the booster vaccination with Comirnaty or Spikevax will allow recruitment.

At Visit 1, after informed consent, inclusion and exclusion criteria will be checked to include or exclude the subject in the trial. Clinical history will be assessed and blood (32ml - Serology, T cell immunity) and saliva (1.5ml) will be taken. At visit 2, 3-8 weeks after after 3rd vaccination, vaccination reactions and clinical history will be assessed. Blood (32ml - serology, T cell immunity) and saliva (1.5ml) will be taken.

At vist 3,6 Month (±3 weeks) after 3rd vaccination, clinical history will be assessed. Blood (8ml - serology) and saliva (1.5ml) will be taken.

Antibody tests and T cell assays will be performed according to protocol.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine

Description

Inclusion Criteria:

1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines. -

Exclusion Criteria:

1. Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
2. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
3. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
4. Having already received a third (booster) vaccination with any COVID-19 vaccine.
5. Women who are pregnant or breastfeeding.
6. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
blood and saliva sampling; blood and saliva samples will be taken	Procedure: blood and saliva samples will be taken; For serology, 8 ml of blood and 1.5 ml saliva samples will be taken at every visit. For testing cellular immunity, additional 24 ml of blood will be drawn at visits 1 and 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.	IgA concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.	3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva.	IgG concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.	3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva.	IgM concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.	3-8 weeks after the third booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgA concentrations to anti-SARS-CoV-2 spike protein in serum	IgA concentrations to anti-SARS-CoV-2 spike protein in serum before the third booster vaccination and 3-8 weeks after the third booster vaccination	3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in serum	IgG concentrations to anti-SARS-CoV-2 spike protein in serum before the third booster vaccination and 3-8 weeks after the third booster vaccination	3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in serum	IgM concentrations to anti-SARS-CoV-2 spike protein in serum before the third booster vaccination and 3-8 weeks after the third booster vaccination	3-8 weeks after the third booster vaccination
IgA concentrations to anti-SARS-CoV-2 spike protein in saliva and serum	IgA concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 6 months after the third booster vaccination	3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva and serum	IgG concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 6 months after the third booster vaccination	3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum	IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 6 months after the third booster vaccination	3-8 weeks after the third booster vaccination
Reactivity of T cells specific for recombinant S protein or other antigens of respiratory pathogens	Reactivity of T cells specific for recombinant S protein or other antigens of respiratory pathogens including endemic coronaviruses before the third booster vaccination and 3-8 weeks and 6 months after the third booster vaccination.	3-8 weeks after the third booster vaccination
Detection of antibodies against other respiratory pathogens	Detection of antibodies against other respiratory pathogens including endemic coronaviruses which might be associated with the response to booster COVID-19 vaccinations	3-8 weeks after the third booster vaccination

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Martin Stradner, Medical University Graz Austria

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Vaccination
• Other Study ID Numbers: CoVVacBoost

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No