Anti-SARS-CoV-2 Antibody ResponseCoVVacBoostNCT05142540
Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines
An observational study of Anti-SARS-CoV-2 Antibody Response, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anti-SARS-CoV-2 Antibody Response
- What is being tested?
- blood and saliva samples will be taken
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2021to 4 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine
Who may be able to join
- 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. -
Who cannot join
- Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
- Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- Having already received a third (booster) vaccination with any COVID-19 vaccine.
- Women who are pregnant or breastfeeding.
- Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) -
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medizinische Universität Graz, Klinische Abteilung für Rheumatologie und Immunologie
Graz, 8036
About this study
Official title: Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines - The CoVVacBoost Study
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.
Read the 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.
- Conditions
- Anti-SARS-CoV-2 Antibody Response
- Being tested
- blood and saliva samples will be taken
- Keywords
- Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and saliva samples will be takenProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| blood and saliva sampling | blood and saliva samples will be taken Receives: Procedure: blood and saliva samples will be taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3-8 weeks after the third booster vaccination
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 3-8 weeks after the third booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Dec 2021
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Why it stopped: No more booster vaccinations are being carried out at the site. Further recruitment is therefore not possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-SARS-CoV-2 Antibody ResponseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Stradner, Principal investigator, Medical University Graz Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142540
- Sponsor's protocol ID
- CoVVacBoost
- Acronym
- CoVVacBoost
- Status last verified
- Jan 2023
- First submitted
- 1 Dec 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines - The CoVVacBoost Study
- ClinicalTrials.gov ID
- NCT05142540
- Acronym / sponsor ID
- CoVVacBoost / CoVVacBoost
- Conditions
- Anti-SARS-CoV-2 Antibody Response
- Keywords
- Vaccination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more booster vaccinations are being carried out at the site. Further recruitment is therefore not possible.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood and saliva sampling | – | Procedure: blood and saliva samples will be takenblood and saliva samples will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (6 listed)
- Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
- Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- Having already received a third (booster) vaccination with any COVID-19 vaccine.
- Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and saliva samples will be takenFor 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. | Procedure or surgery | blood and saliva sampling |
Primary outcome
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.
Time frame: 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.
Time frame: 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.
Time frame: 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.
8 secondary outcomes
IgA concentrations to anti-SARS-CoV-2 spike protein in serum
Time frame: 3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in serum
Time frame: 3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in serum
Time frame: 3-8 weeks after the third booster vaccination
IgA concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
Time frame: 3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
Time frame: 3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum
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
Time frame: 3-8 weeks after the third booster vaccination
Detection of antibodies against other respiratory pathogens
Time frame: 3-8 weeks after the third booster vaccination
Results and safety
The study was stopped early (reason given: No more booster vaccinations are being carried out at the site. Further recruitment is therefore not possible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Stradner principal investigator
Medical University Graz Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-SARS-CoV-2 Antibody Response, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No more booster vaccinations are being carried out at the site. Further recruitment is therefore not possible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva. (time frame: 3-8 weeks after the third booster vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.