COBRA re-KAI study: research into the immune response of COVID-19 revaccination after stem cell transplant or B-cel depleting immuno(chemo)therapy.

COBRA re-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after re-vaccination of a kaleidoscopic group of hematological patients: what*s the impact? - COBRA-RE-KAI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56570

Enrollment

250

Registered

2023-11-06

Start date

2024-05-27

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination response vaccine effectiveness

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  Age >=18 years Patient groups: Patients who received:  1. B cell depleting immunochemotherapy (n=50), at least 8 months after last B-cel depleting therapy before first vaccination. 2. B cell depleting CAR T cell therapy (n=50); 3 months after treatment. 3. Patients who received autologous HCT (myeloablative chemotherapy: high dose melphalan (HDM)) (n=50); 3 months after treatment before first vaccination.  4. Patients who received autologous HCT (myeloablative chemotherapy: BCNU-etoposide-Ara-C-Melphalan (BEAM) or BCNU-thiotepa) (n=50); at least 3 months after transplantation with a maximum of 6 months before first vaccination.  Group 5: Patients who received allogeneic HCT (various indications) (n=50) 3 months after transplantation. 

Exclusion criteria

Exclusion criteria:  - Unwilling or unable to give informed consent - Known allergy to one of the components of the vaccine - Patients with a life expectancy of < 12 months 

Design outcomes

Primary

Measure	Time frame
1. Loss of and residual SARS-CoV-2 specific cellular and humoral immunity prior to start of the revaccination schedule (baseline); 2. SARS-CoV-2 antibody concentration 7 days after first revaccination as a measure of residual immunity 3. SARS-CoV-2 antibody concentration and neutralization 28 days after each re-vaccination 4. Number of revaccinations needed for each patient group to reach sufficient (normal level) SARS-CoV-2 antibody concentrations;	—

Measure

Time frame

1. Loss of and residual SARS-CoV-2 specific cellular and humoral immunity prior to start of the revaccination schedule (baseline); 2. SARS-CoV-2 antibody concentration 7 days after first revaccination as a measure of residual immunity 3. SARS-CoV-2 antibody concentration and neutralization 28 days after each re-vaccination 4. Number of revaccinations needed for each patient group to reach sufficient (normal level) SARS-CoV-2 antibody concentrations;

—

Secondary

Measure	Time frame
1. SARS-CoV-2 antibody concentrations, antibody maturation, antibody glycosylation, B cell maturation, spike specific CD4 and CD8 T cells prior to and 28 days after each vaccination; 2. Clinical (e.g. hematologic diagnosis, current and past therapies including immunosuppressive drugs, date of last therapy, response to therapy) and immune (e.g. peripheral blood B and T cell numbers, IgG concentrations) parameters that determine cellular and humeral responses to COVID-19 re-vaccination; 3. Effect of previous SARS-CoV2 infection on COVID-19 re-vaccination responses; 4. Serious adverse events (SAE) < 7 days after each COVID-19 re-vaccination; 5. SARS-CoV-2 breakthrough infections and severity (including death) after COVID-19 re-vaccination	—

Measure

Time frame

1. SARS-CoV-2 antibody concentrations, antibody maturation, antibody glycosylation, B cell maturation, spike specific CD4 and CD8 T cells prior to and 28 days after each vaccination; 2. Clinical (e.g. hematologic diagnosis, current and past therapies including immunosuppressive drugs, date of last therapy, response to therapy) and immune (e.g. peripheral blood B and T cell numbers, IgG concentrations) parameters that determine cellular and humeral responses to COVID-19 re-vaccination; 3. Effect of previous SARS-CoV2 infection on COVID-19 re-vaccination responses; 4. Serious adverse events (SAE) < 7 days after each COVID-19 re-vaccination; 5. SARS-CoV-2 breakthrough infections and severity (including death) after COVID-19 re-vaccination

—

Countries

Netherlands

Contacts

Public ContactM.D. Hazenberg

Amsterdam UMC

hematology@amsterdamumc.nl020 - 444 2604

Outcome results