Humoral and Cellular Immune Response to COVID-19 Vaccines in Immunocompromised and Healthy Individuals

NCT ID: NCT04858607

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 373 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2023-01-20

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.

Detailed Description

The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having consented and fulfilling the inclusion and exclusion criteria are included in the trial. A baseline visit will take place up to 60 days before the planned date of vaccination according to the Austrian vaccination plan. Scheduled vaccination with any COVID-19 vaccine approved in Austria will allow recruitment. If appropriate pre-vaccine samples from study participants exist in the biobank of the Medical University of Graz, patients may also be included in the study after vaccination starting with visit 3. In this case the biomaterial available at the biobank will be used for the analyses planned on visit 1. The investigators will not influence the date of vaccination or the type of the vaccine used. After first vaccination a telephone visit (visit 2) will assess adverse events and schedule visit 3 at the appropriate time after the second vaccination. At visit 3 the patient's vaccination certificate will be checked to verify correct vaccination and document the type of vaccine received. Further visits (5-6) will be performed for up to two years after the second vaccination. This follow-up period will allow an assessment of the duration of the immune response. The data recorded directly on the Case Report Form (CRF) are considered to be source data. COVID-19 vaccination, COVID-19 infection, Vaccination history, Pregnancy test, Adverse Events, BMI (Body Mass Index), and Laboratory Specimen Collection are recorded directly on the CRF and therefore are considered to be source data. Data will be merged in an electronic database (RDA Research, Documentation & Analysis; Medical University of Graz, version 07.03.2019). Case Report Forms (CRFs) will be inspected in respect of their accuracy and completeness and compared to original data by the monitor.

Conditions

Covid19; Immunosuppression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Immunocompromised individuals

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

Blood sample

Intervention Type: DIAGNOSTIC_TEST

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

Saliva sample

Intervention Type: DIAGNOSTIC_TEST

Antibody tests

Healthy individuals

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

Blood sample

Intervention Type: DIAGNOSTIC_TEST

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

Saliva sample

Intervention Type: DIAGNOSTIC_TEST

Antibody tests

Interventions

Blood sample

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

Intervention Type: DIAGNOSTIC_TEST

Saliva sample

Antibody tests

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 to 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. chronic lymphatic leukemia, MM) currently not receiving specific treatment.

or

6. Patients >3 months but <12 months after autologous HSCT (hematopoietic stem cell transplantation).

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 (graft-versus-host disease) and persistent immunodeficiency.

Exclusion Criteria

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 (Chimeric Antigen Receptor).

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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Stradner, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

CoVVac

Identifier Type: -

Identifier Source: org_study_id