Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients

September 26, 2023 updated by: University Hospital, Ghent
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • UH Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients receiving a different of vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Diagnostic test: Blood draw
Blood draw
Active Comparator: HIV positive CD4<350 cells/mm^3
Diagnostic test: Blood draw
Blood draw
Active Comparator: Immune-compromised patients- department rheumatology
Diagnostic test: Blood draw
Blood draw
Active Comparator: Immune-compromised patients- department nephrology
Diagnostic test: Blood draw
Blood draw
Active Comparator: Immune-compromised patients- department neurology
Diagnostic test: Blood draw
Blood draw
Active Comparator: Primary immune deficiency en common variable immunodeficiency
Diagnostic test: Blood draw
Blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prior or at the time of first dose of vaccine until 12 months after second dose of vaccine
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
prior or at the time of first dose of vaccine until 12 months after second dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2021

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VACCIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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