Clinical trial NCT05142540: Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines
Official title: Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines - The CoVVacBoost Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anti-SARS-CoV-2 Antibody Response
Keywords: Vaccination
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine

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.

Eligibility criteria: 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) -

Primary outcomes:
measure: Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgG concentrations to anti-SARS-CoV-2 spike protein in saliva.
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgM concentrations to anti-SARS-CoV-2 spike protein in saliva.
timeFrame: 3-8 weeks after the third booster vaccination
Secondary outcomes:
measure: IgA concentrations to anti-SARS-CoV-2 spike protein in serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgG concentrations to anti-SARS-CoV-2 spike protein in serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgM concentrations to anti-SARS-CoV-2 spike protein in serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgA concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgG concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
timeFrame: 3-8 weeks after the third booster vaccination
measure: Reactivity of T cells specific for recombinant S protein or other antigens of respiratory pathogens
timeFrame: 3-8 weeks after the third booster vaccination
measure: Detection of antibodies against other respiratory pathogens
timeFrame: 3-8 weeks after the third booster vaccination
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie
Study officials:
affiliation: Medical University Graz Austria
name: Martin Stradner
role: PRINCIPAL_INVESTIGATOR
References: