Covid (Coronavirus disease)- 19 immunisation MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet the following 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Quantitative and functional comparison of the salivary anti-SARS-CoV-2 antibody response before and after 3rd booster vaccination. ;Secondary Objective: To answer the following research questions: 1. Is there a difference in concentration and persistence of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination? 2. Is there any difference in the neutralizing capacity of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination towards the various SARS-CoV-2 variants? 3. Do saliva and serum antibody levels correlate? Is saliva a possible surrogate sample to monitor the antibody response to COVID vaccines? 4. How does the neutralizing capacity of saliva and serum antibodies compare? 5. Are different salivary antibody profiles in terms of quantity and subclasses associated with previous exposure to other respiratory pathogens including endemic coronaviruses? 6. Is a difference in the T cell response associated with different antibody profiles in saliva and serum?;Primary end point(s): IgA, IgG and IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 3-8 weeks and 6 months after the third booster vaccination, measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays. ;Timepoint(s) of evaluation of this end point: Before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • IgA, IgG and 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 • IgA, IgG and 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 • Reactivity of recombinant S protein-specific T cells before the third booster vaccination and 3-8 weeks and 6 months 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;Timepoint(s) of evaluation of this end point: Before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
Medical University of Graz
Outcome results
None listed