HIV SeropositivityNCT05672654
Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients
A study testing Blood draw in people with HIV Seropositivity and Immunodeficiency, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, Immunodeficiency, Vaccination Reaction
- What is being tested?
- Blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2021to 1 Sep 2023
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Following patient groups receiving the Pfizer vaccine
- HIV-positive patients with CD4 < 350 cellen/mm3
- Common variable immunodeficiency disorders en primary immunodeficiency disorders
- Immune-compromised patients hospitalized at rheumatology/neurology/nephrology
Who cannot join
- patients receiving a different of vaccine
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. For antibody detection, LIAISON® SARS-CoV-2 TrimericS assay (DiaSorin) will be used and for the evaluation of cellular immunity - QuantiFERON SARS-CoV-2 assay (QIAGEN).
Read the detailed description
The national vaccination campaign against COVID-19 is ongoing and high risk patients are invited. Within the group of high risk patients, there are several groups of people who are for some reason immune-compromised and whose immune system is not functioning adequately. As vaccines against COVID-19 have become available in Europe as a matter of urgency, there are currently insufficient or no data available on the generation of post-vaccinal response in different groups of these immunocompromised patients. The theoretical assumption that the generation of post-vaccinal response in these patients is different from that in immunocompetent individuals is valid, as it has been shown for other vaccines, e.g. against influenza and pneumococcal disease, that the use of immunosuppressive treatments such as asrituximab, methotrexate and rituximab suppress the production of neutralising antibodies. It is known that vaccines against COVID-19 are also capable of inducing a clear functional cellular response in addition to neutralising antibody production, the modalities of which are also insufficiently or not known in these patients.
As mentioned is the goal of VACCIm to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients.
Within this prospective observational study, serum samples (for subsequent measurement with LIAISON® SARS-CoV-2 TrimericS assay) and lithium-heparin whole blood samples (for subsequent measurement with QuantiFERON SARS-CoV-2 assay) will be collected from control immune-competent individuals and immune-compromised patients within the following groups:
- Common variable immunodeficiency disorders and primary immunodeficiency disorders
- HIV-positive patients with CD4 < 350 cells/mm3
- Immune-compromised patients in rheumatology, neurology and nephrology
In order to assess both humoral and cellular responses as fully as possible, both measurements are performed at the following time points:
T0: before (=prior) or at time of first dose of vaccine T1: 21-28 days after first dose of vaccine T2: at least 10 days after second dose of vaccine T3: after 3 months after second dose of vaccine T4: after 6 months from second dose of vaccine T5: after 12 months from second dose of vaccine
- Conditions
- HIV Seropositivity, Immunodeficiency, Vaccination Reaction, Covid19
- Being tested
- Blood draw
- Medical subject headings
- HIV Seropositivity, Immunologic Deficiency Syndromes, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Blood draw
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
| HIV positive CD4<350 cells/mm^3 | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
| Immune-compromised patients- department rheumatology | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
| Immune-compromised patients- department nephrology | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
| Immune-compromised patients- department neurology | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
| Primary immune deficiency en common variable immunodeficiency | Active comparator | Not described Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response
Detection of Antibodies
Measured: prior or at the time of first dose of vaccine until 12 months after second dose of vaccine
Cellular immune response
DetectionINF-gamma by functional CD4+ and CD8+ cells
Measured: prior or at the time of first dose of vaccine until 12 months after second dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start10 May 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Responsibility for registering this study lies with the sponsor, DiaSorin, and not with our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672654
- Sponsor's protocol ID
- VACCIM
- Status last verified
- Sep 2024
- First submitted
- 20 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT05672654
- Acronym / sponsor ID
- VACCIM
- Conditions
- HIV Seropositivity, Immunodeficiency, Vaccination Reaction, Covid19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Responsibility for registering this study lies with the sponsor, DiaSorin, and not with our institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 5 Jan 2023 (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 aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. For antibody detection, LIAISON® SARS-CoV-2 TrimericS assay (DiaSorin) will be used and for the evaluation of cellular immunity - QuantiFERON SARS-CoV-2 assay (QIAGEN).
Detailed description
The national vaccination campaign against COVID-19 is ongoing and high risk patients are invited. Within the group of high risk patients, there are several groups of people who are for some reason immune-compromised and whose immune system is not functioning adequately. As vaccines against COVID-19 have become available in Europe as a matter of urgency, there are currently insufficient or no data available on the generation of post-vaccinal response in different groups of these immunocompromised patients. The theoretical assumption that the generation of post-vaccinal response in these patients is different from that in immunocompetent individuals is valid, as it has been shown for other vaccines, e.g. against influenza and pneumococcal disease, that the use of immunosuppressive treatments such as asrituximab, methotrexate and rituximab suppress the production of neutralising antibodies. It is known that vaccines against COVID-19 are also capable of inducing a clear functional cellular response in addition to neutralising antibody production, the modalities of which are also insufficiently or not known in these patients.
As mentioned is the goal of VACCIm to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients.
Within this prospective observational study, serum samples (for subsequent measurement with LIAISON® SARS-CoV-2 TrimericS assay) and lithium-heparin whole blood samples (for subsequent measurement with QuantiFERON SARS-CoV-2 assay) will be collected from control immune-competent individuals and immune-compromised patients within the following groups:
- Common variable immunodeficiency disorders and primary immunodeficiency disorders
- HIV-positive patients with CD4 < 350 cells/mm3
- Immune-compromised patients in rheumatology, neurology and nephrology
In order to assess both humoral and cellular responses as fully as possible, both measurements are performed at the following time points:
T0: before (=prior) or at time of first dose of vaccine T1: 21-28 days after first dose of vaccine T2: at least 10 days after second dose of vaccine T3: after 3 months after second dose of vaccine T4: after 6 months from second dose of vaccine T5: after 12 months from second dose of vaccine
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: Blood draw |
| HIV positive CD4<350 cells/mm^3 | Active comparator | Diagnostic Test: Blood draw |
| Immune-compromised patients- department rheumatology | Active comparator | Diagnostic Test: Blood draw |
| Immune-compromised patients- department nephrology | Active comparator | Diagnostic Test: Blood draw |
| Immune-compromised patients- department neurology | Active comparator | Diagnostic Test: Blood draw |
| Primary immune deficiency en common variable immunodeficiency | Active comparator | Diagnostic Test: Blood draw |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Following patient groups receiving the Pfizer vaccine
- HIV-positive patients with CD4 < 350 cellen/mm3
- Common variable immunodeficiency disorders en primary immunodeficiency disorders
- Immune-compromised patients hospitalized at rheumatology/neurology/nephrology
Key exclusion criteria (1 listed)
- patients receiving a different of vaccine
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 drawBlood draw | Diagnostic test | Control group, HIV positive CD4<350 cells/mm^3, Immune-compromised patients- department nephrology, Immune-compromised patients- department neurology, Immune-compromised patients- department rheumatology, Primary immune deficiency en common variable immunodeficiency |
Primary outcome
Humoral immune response
Time frame: prior or at the time of first dose of vaccine until 12 months after second dose of vaccine
Detection of Antibodies
Cellular immune response
Time frame: prior or at the time of first dose of vaccine until 12 months after second dose of vaccine
DetectionINF-gamma by functional CD4+ and CD8+ cells
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw in people with HIV Seropositivity and Immunodeficiency, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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 withdrawn before enrolling participants, so there are no results.
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?
Humoral immune response (time frame: prior or at the time of first dose of vaccine until 12 months after second dose of vaccine). The study lists 2 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 19 Sep 2024.