An observational study in Anti-SARS-CoV-2 Antibody Response, sponsored by Medical University of Graz. Terminated at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Medical University of Graz · Observational
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.
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.
Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-8 weeks after the third booster vaccination
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 3-8 weeks after the third booster vaccination
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Graz