To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Immune disorders NEC
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Current guidelines in the Netherlands and abroad advise revaccination for
patients who were B cell depleted at the time of the primary COVID-19
vaccination series and for patients who received an autologous or allogeneic
HCT after the primary COVID-19 vaccination series.6 It is advised to
revaccinate with 3 doses of a mRNA vaccin given 4 weeks apart, followed by a
booster vaccination > 3 months later, although data substantiating this
schedule are lacking. In order to design revaccination schedules for hematology
patients who lost protective immunity against COVID-19 after HCT, or who were B
cell depleted after they had received vaccination. More research is needed to
investigate the immune response during revaccination.
Study objective
To answer the following questions:
1. Who are the patients that need to be revaccinated?
2. How many vaccinations are needed to restore SARS-CoV-2 immunity?
3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be
predicted?
To answer these questions we will revaccinate all eligible patients according
to the RIVM guidelines with 3 doses of mRNA COVID-19 vaccine given 4 weeks
apart, followed by a booster vaccination > 3 months later, and we will measure
antibody concentrations and cellular immunity before and 28 days after each
vaccination. After the first vaccination we will also do this measurement on
day 7 after vaccination to test for residual immunity.
Study design
Observational cohort study among 250 hematology patients categorized into 5
different groups (n=50 per group). All participants will receive 3 mRNA
COVID-19 vaccination doses 4 weeks apart, followed by a booster vaccination > 3
months later, per the Dutch guidelines. Cellular and humoral immunity will be
measured at baseline (the day of the 1st vaccination) and 28 days after each
vaccination and 7 days after the first vaccination.
Study burden and risks
Observational study without additional risks apart from very small risks
associated with venous punction (bruising and mild discomfort).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.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.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85613.018.23 |