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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-10-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anti-SARS-CoV-2 Antibody Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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blood and saliva sampling

blood and saliva samples will be taken

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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) -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes