NCT04858607

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

April 21, 2021

Last Update Submit

February 8, 2023

Conditions

Covid19Immunosuppression

Keywords

Vaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    At day 21-28 after the second vaccination

Secondary Outcomes (11)

  • Seroconversion

    6, 12 and 24 months after vaccination.

  • Concentrations of recombinant S protein-binding IgG (immunoglobulin G)

    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)

    At day 21-28 as well as 12 and 24 months after the second vaccination.

  • IFNγ production of T cells

    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

    At day 21-28 as well as 12 and 24 months after the second vaccination.

  • +6 more secondary outcomes

Study Arms (2)

Immunocompromised individuals

Patients with primary or secondary immunodeficiency planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan.

Diagnostic Test: Blood sampleDiagnostic Test: Saliva sample

Healthy individuals

Healthy people planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan.

Diagnostic Test: Blood sampleDiagnostic Test: Saliva sample

Interventions

Blood sampleDIAGNOSTIC_TEST

Serology, immune status, T cell immunity, and T cell aging.

Healthy individualsImmunocompromised individuals
Saliva sampleDIAGNOSTIC_TEST

Antibody tests

Healthy individualsImmunocompromised individuals

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Immunodeficient participants and immunocompetent participants (i.e., healthy participants)

You may qualify if:

  • Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
  • 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.
  • Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. chronic lymphatic leukemia, MM) currently not receiving specific treatment.
  • Patients \>3 months but \<12 months after autologous HSCT (hematopoietic stem cell transplantation).
  • Patients \>3 months but \<12 months after allogeneic HSCT. or
  • Recipients of HSCT \>12 months after allogeneic HSCT but under immunosuppressive therapy.
  • Patients with chronic GvHD (graft-versus-host disease) and persistent immunodeficiency.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

All samples will be stored at the Biobank of the Medical University of Graz for further analysis.

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Martin Stradner, Prof.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

April 19, 2021

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)