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

NCT05672654 | Withdrawn

• 1 other identifier: VACCIM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

HIV Seropositivity; Immunodeficiency; Vaccination Reaction; Covid19

Outcome Measures

Primary Outcomes (2)

• Humoral immune response

  Detection of Antibodies

  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

  prior or at the time of first dose of vaccine until 12 months after second dose of vaccine

Study Arms (6)

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

Interventions

Blood draw DIAGNOSTIC_TEST

Blood draw

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

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients receiving a different of vaccine

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UH Ghent

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

HIV Seropositivity; Immunologic Deficiency Syndromes; COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: May 10, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)