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?
- Conditions
- Vaccination responsevaccine effectiveness100188491002766510047438
- Registration Number
- NL-OMON56570
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 250
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.6
2. B cell depleting CAR T cell therapy (n=50); 3 months after treatment.6
3. Patients who received autologous HCT (myeloablative chemotherapy: high dose
melphalan (HDM)) (n=50); 3 months after treatment before first vaccination 6.
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. 6
Group 5: Patients who received allogeneic HCT (various indications) (n=50) 3
months after transplantation.
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Loss of and residual SARS-CoV-2 specific cellular and humoral immunity prior<br /><br>to start of the revaccination schedule (baseline);<br /><br>2. SARS-CoV-2 antibody concentration 7 days after first revaccination as a<br /><br>measure of residual immunity<br /><br>3. SARS-CoV-2 antibody concentration and neutralization 28 days after each<br /><br>re-vaccination<br /><br>4. Number of revaccinations needed for each patient group to reach sufficient<br /><br>(normal level) SARS-CoV-2 antibody concentrations;</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. SARS-CoV-2 antibody concentrations, antibody maturation, antibody<br /><br>glycosylation, B cell maturation, spike specific CD4 and CD8 T cells prior to<br /><br>and 28 days after each vaccination;<br /><br>2. Clinical (e.g. hematologic diagnosis, current and past therapies including<br /><br>immunosuppressive drugs, date of last therapy, response to therapy) and immune<br /><br>(e.g. peripheral blood B and T cell numbers, IgG concentrations) parameters<br /><br>that determine cellular and humeral responses to COVID-19 re-vaccination;<br /><br>3. Effect of previous SARS-CoV2 infection on COVID-19 re-vaccination responses;<br /><br>4. Serious adverse events (SAE) < 7 days after each COVID-19 re-vaccination;<br /><br>5. SARS-CoV-2 breakthrough infections and severity (including death) after<br /><br>COVID-19 re-vaccination</p><br>