Humoral (antibodies) and cellular (white blood cells) immune response to COVID-19 vaccines in immunocompromised (people with impaired immune system) and healthy individuals – The CoVVac study

Phase 1

• Conditions: Active immunisation to prevent COVID-19 in immunocompromised individuals.; MedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2021-001040-10-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-26
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria:
1.Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
or
2.Patients with primary immunodeficiencies
or
3.Patients with B-cell depleting therapy due autoimmune disease
or
4.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
5.Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.
or
6.Patients >3 months but <12 months after autologous HSCT.
or
7.Patients >3 months but <12 months after allogeneic HSCT.
or
8.Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
or
9.Patients with chronic GvHD and persistent immunodeficiency.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

Exclusion Criteria

Subjects meeting any of the following criteria cannot be enrolled into the trial:

Healthy participants
1.Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
2.Presence of a disease requiring change in therapy during 4 weeks before enrollment.
3.Any contraindications to the vaccine planned to receive as listed in the product characteristics.
4.Lack of willingness to undergo serial blood draws and attend follow-up appointments.
5.Women who are pregnant or breastfeeding.
6.Previous vaccination with any coronavirus vaccine.
7.Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).

Immunodeficient participants
1.Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells).
2.Patients with hematological malignancies in remission and >12 months after end of specific therapy.
3.Patients within three months from HSCT.
4.Any contraindications to the vaccine planned to receive as listed in the product characteristics.
5.Lack of willingness to undergo serial blood draws and attend follow-up appointments.
6.Women who are pregnant or breastfeeding.
7.Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
8.Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified