Covid19CoVVacNCT04858607
Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals
An observational study of Covid19 and Immunosuppression, run by Medical University of Graz at 1 site in Austria.
Trial summary
Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Immunosuppression
- What is being tested?
- Blood sample and Saliva sample
- Type of treatment
- Vaccines
- How many people
- 373 participants
- Where
- 1 siteAustria
- Study dates
- 19 Apr 2021to 20 Jan 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Immunodeficient participants and immunocompetent participants (i.e., healthy participants)
Who may be able to join
- Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
- or
- Patients with primary immunodeficiencies or
- Patients with B-cell depleting therapy due to autoimmune disease or
- Patients with benign and malignant hematological diseases receiving specific Treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.
- or
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- Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. chronic lymphatic leukemia, MM) currently not receiving specific treatment.
- or
- Patients >3 months but <12 months after autologous HSCT (hematopoietic stem cell transplantation).
- or
- Patients >3 months but <12 months after allogeneic HSCT. or
- Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
- or
- Patients with chronic GvHD (graft-versus-host disease) and persistent immunodeficiency.
Who cannot join
- Healthy participants
- Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
- Presence of a disease requiring change in therapy during 4 weeks before enrollment.
- 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.
- Women who are pregnant or breastfeeding.
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- Previous vaccination with any coronavirus vaccine.
- Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
- Immunodeficient participants
- Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells (Chimeric Antigen Receptor).
- Patients with hematological malignancies in remission and >12 months after end of specific therapy.
- Patients within three months from HSCT.
- 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.
- Women who are pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
- Patients 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.
About this study
Official title: Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals - The CoVVac Study
Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. The investigators will assess the humoral and cellular response to COVID-19 vaccination in these subjects in detail. Furthermore, factors associated with good response to vaccination will be identified. The results of this study will help to guide future recommendations on COVID-19 vaccination in this population.
Read the detailed description
The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having consented and fulfilling the inclusion and exclusion criteria are included in the trial. A baseline visit will take place up to 60 days before the planned date of vaccination according to the Austrian vaccination plan. Scheduled vaccination with any COVID-19 vaccine approved in Austria will allow recruitment. If appropriate pre-vaccine samples from study participants exist in the biobank of the Medical University of Graz, patients may also be included in the study after vaccination starting with visit 3. In this case the biomaterial available at the biobank will be used for the analyses planned on visit 1. The investigators will not influence the date of vaccination or the type of the vaccine used. After first vaccination a telephone visit (visit 2) will assess adverse events and schedule visit 3 at the appropriate time after the second vaccination. At visit 3 the patient's vaccination certificate will be checked to verify correct vaccination and document the type of vaccine received. Further visits (5-6) will be performed for up to two years after the second vaccination. This follow-up period will allow an assessment of the duration of the immune response. The data recorded directly on the Case Report Form (CRF) are considered to be source data. COVID-19 vaccination, COVID-19 infection, Vaccination history, Pregnancy test, Adverse Events, BMI (Body Mass Index), and Laboratory Specimen Collection are recorded directly on the CRF and therefore are considered to be source data. Data will be merged in an electronic database (RDA Research, Documentation \& Analysis; Medical University of Graz, version 07.03.2019). Case Report Forms (CRFs) will be inspected in respect of their accuracy and completeness and compared to original data by the monitor.
- Conditions
- Covid19, Immunosuppression
- Being tested
- Blood sample, Saliva sample
- Keywords
- Vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Serology, immune status, T cell immunity, and T cell aging.
Saliva sampleDiagnostic test
Antibody tests
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised individuals | Patients with primary or secondary immunodeficiency planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan. Receives: Diagnostic Test: Blood sample; Diagnostic Test: Saliva sample | |
| Healthy individuals | Healthy people planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan. Receives: Diagnostic Test: Blood sample; Diagnostic Test: Saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of anti-SARS-CoV-2 spike protein humoral immune response.
The levels of anti-SARS-CoV-2 (severe acute respiratory syndrome-Covid Virus) spike protein humoral immune response measured by SARS-CoV-2 antigen-binding Ig assay comparing immunocompromised patients to healthy controls.
Measured: At day 21-28 after the second vaccination
Secondary outcomes (11)
Seroconversion
Change of Seroconversion measured by SARS-CoV-2 antigen-binding Ig assay 6, 12 and 24 months after vaccination.
Measured: 6, 12 and 24 months after vaccination.
Concentrations of recombinant S protein-binding IgG (immunoglobulin G)
Change of Concentrations of recombinant S protein-binding IgG after second vaccination in comparison to response after first vaccination.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
Concentrations of secretory and serum IgA in comparison to IgG and IgM (immunoglobulin M)
Change of Concentrations of secretory and serum IgA in comparison to IgG and IgM after second vaccination in immunocompromised, in recovered individuals and in healthy controls.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
IFNγ production of T cells
Change of IFNγ (Interferone gamma) production of T cells after SARS-CoV-2 antigen exposure, measured by FACS (fluorescence-activated cell sorter) and ELISpot.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
Cross-reactive antibodies predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: prior CoV infection (cross-reactive antibodies). Evaluation of the influence of previous infections caused by endemic CoV (proven through cross-reactive antibodies) on the vaccine response in immunocompromised individuals and in COVID-19 recovered individuals compared to controls.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
Quantitative immunoglobulins predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: quantitative immunoglobulins.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
B cell subsets predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: B cell subsets.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell subsets predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: T cell subsets.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell aging predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: T cell aging (TCR diversity, telomere length, TREC levels).
Measured: 60-0 days before first vaccination.
Occurence of neutralizing antibodies by means of SARS-CoV-2 neutralizing assays.
Neutralizing capacity of antibodies in respect of different SARSCoV-2 variants.
Measured: At day 21-28 as well as 12 and 24 months after the second vaccination.
Correlation of diet and body fat with seroconversion
Correlation of diet and body fat with seroconversion after second vaccination.
Measured: At day 21-28 and 12 months after the second vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start19 Apr 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Stradner, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858607
- Sponsor's protocol ID
- CoVVac
- Acronym
- CoVVac
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals - The CoVVac Study
- ClinicalTrials.gov ID
- NCT04858607
- Acronym / sponsor ID
- CoVVac / CoVVac
- Conditions
- Covid19, Immunosuppression
- Keywords
- Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 26 Apr 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.
Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. The investigators will assess the humoral and cellular response to COVID-19 vaccination in these subjects in detail. Furthermore, factors associated with good response to vaccination will be identified. The results of this study will help to guide future recommendations on COVID-19 vaccination in this population.
Detailed description
The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having consented and fulfilling the inclusion and exclusion criteria are included in the trial. A baseline visit will take place up to 60 days before the planned date of vaccination according to the Austrian vaccination plan. Scheduled vaccination with any COVID-19 vaccine approved in Austria will allow recruitment. If appropriate pre-vaccine samples from study participants exist in the biobank of the Medical University of Graz, patients may also be included in the study after vaccination starting with visit 3. In this case the biomaterial available at the biobank will be used for the analyses planned on visit 1. The investigators will not influence the date of vaccination or the type of the vaccine used. After first vaccination a telephone visit (visit 2) will assess adverse events and schedule visit 3 at the appropriate time after the second vaccination. At visit 3 the patient's vaccination certificate will be checked to verify correct vaccination and document the type of vaccine received. Further visits (5-6) will be performed for up to two years after the second vaccination. This follow-up period will allow an assessment of the duration of the immune response. The data recorded directly on the Case Report Form (CRF) are considered to be source data. COVID-19 vaccination, COVID-19 infection, Vaccination history, Pregnancy test, Adverse Events, BMI (Body Mass Index), and Laboratory Specimen Collection are recorded directly on the CRF and therefore are considered to be source data. Data will be merged in an electronic database (RDA Research, Documentation \& Analysis; Medical University of Graz, version 07.03.2019). Case Report Forms (CRFs) will be inspected in respect of their accuracy and completeness and compared to original data by the monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised individuals | – | Diagnostic Test: Blood sample, Diagnostic Test: Saliva samplePatients with primary or secondary immunodeficiency planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan. |
| Healthy individuals | – | Diagnostic Test: Blood sample, Diagnostic Test: Saliva sampleHealthy people planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunodeficient participants and immunocompetent participants (i.e., healthy participants)
Key inclusion criteria (14 listed)
- Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
- or
- Patients with primary immunodeficiencies or
- Patients with B-cell depleting therapy due to autoimmune disease or
- Patients with benign and malignant hematological diseases receiving specific Treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.
Key exclusion criteria (17 listed)
- Healthy participants
- Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
- Presence of a disease requiring change in therapy during 4 weeks before enrollment.
- 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.
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 sampleSerology, immune status, T cell immunity, and T cell aging. | Diagnostic test | Healthy individuals, Immunocompromised individuals |
| Saliva sampleAntibody tests | Diagnostic test | Healthy individuals, Immunocompromised individuals |
Primary outcome
The levels of anti-SARS-CoV-2 spike protein humoral immune response.
Time frame: At day 21-28 after the second vaccination
The levels of anti-SARS-CoV-2 (severe acute respiratory syndrome-Covid Virus) spike protein humoral immune response measured by SARS-CoV-2 antigen-binding Ig assay comparing immunocompromised patients to healthy controls.
11 secondary outcomes
Seroconversion
Time frame: 6, 12 and 24 months after vaccination.
Concentrations of recombinant S protein-binding IgG (immunoglobulin G)
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Concentrations of secretory and serum IgA in comparison to IgG and IgM (immunoglobulin M)
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
IFNγ production of T cells
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Cross-reactive antibodies predicting the response to COVID-19 vaccinations
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Quantitative immunoglobulins predicting the response to COVID-19 vaccinations
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
B cell subsets predicting the response to COVID-19 vaccinations
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell subsets predicting the response to COVID-19 vaccinations
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell aging predicting the response to COVID-19 vaccinations
Time frame: 60-0 days before first vaccination.
Occurence of neutralizing antibodies by means of SARS-CoV-2 neutralizing assays.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Correlation of diet and body fat with seroconversion
Time frame: At day 21-28 and 12 months after the second vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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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, Prof. principal investigator
Medical University of Graz
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 Covid19 and Immunosuppression, 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 14 inclusion and 17 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: finished, as of the sponsor's last update on 9 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The levels of anti-SARS-CoV-2 spike protein humoral immune response. (time frame: At day 21-28 after the second vaccination). 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 9 Feb 2023.