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

Terminated

• Conditions: Anti-SARS-CoV-2 Antibody Response
• Interventions: Procedure: blood and saliva samples will be taken

• Registration Number: NCT05142540
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Primary Completion: 2022-10-04
• Study Completion: 2022-10-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
blood and saliva sampling	blood and saliva samples will be taken	blood and saliva samples will be taken

Primary Outcome Measures

Name	Time	Method
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.	3-8 weeks after the third booster vaccination	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.
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva.	3-8 weeks after the third booster vaccination	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.
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva.	3-8 weeks after the third booster vaccination	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie; 🇦🇹 Graz, Austria