PRIMARY OBJECTIVE: -To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancerSECONDARY OBJECTIVES:To assess in children with cancer after SARS-CoV 2 vaccination:- durability of the antibody response…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the antibody based immune response to
vaccination against COVID-19 28 days (t=3) after the second vaccination as
compared to a control cohort.
Secondary outcome
-Titers of SARS-CoV-2 specific antibodies at 12 months after the second
vaccination
-SARS-CoV2 specific T cell response measured at baseline, 21-28 days after
first vaccination and at 28 days after the second vaccination
Background summary
Immune responses in childrens with cancer during and shortly after end of
treatment seems to be perturbed due to interference with B cell development and
lack of T-cell help. This may have important consequences both on the quantity
but also quality (glycosylation) of the antibody response, and thereby affect
the clinical response. Therefore, in our current study proposal, we want to
follow-up the effect of SARS-COV-2 vaccination in the vaccinated patients, as
it is not yet clear to what extent they are able to generate both a humoral
and/or cellular response against SARS-COV-2 with the regular vaccination
scheme. If not, these children may need additional vaccinations to become
protected.
In addition, by studying the association between the immune response with
details on the disease status, treatment phase and immune-status at
vaccination, this study will generate data on which rational future vaccination
strategies in this patient category at great risk of infections, can be based
on.
Study objective
PRIMARY OBJECTIVE:
-To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2
vaccination in children with cancer
SECONDARY OBJECTIVES:
To assess in children with cancer after SARS-CoV 2 vaccination:
- durability of the antibody response
- SARS-CoV-2-specific T and B cell response
- antibody response as compared to healthy children
- the contribution of a 3rd vaccination
EXPLORATORY OBJECTIVES:
To assess in children with cancer after SARS-CoV 2 vaccination:
- the association between baseline disease and immune parameters and the immune
response to SARS-CoV-2 vaccination
- the neutralizing capacity of anti-COVID-19 antibodies
- the reported incidence of SARS-CoV-2 infection and outcome of COVID-19
disease 12 months after SARS-CoV-2 vaccination
Study design
This is a prospective cohort study to evaluate the efficacy of SARS-CoV-2
vaccination in children with cancer. The study includes 4 patient cohorts,
which will be analysed together to answer the research questions.
Study burden and risks
There is no study-related risk. The burden is minimal. Participation in this
study requires a maximum of 5 visits (cohort I) or 3 visits (cohort II, cohort
III, and cohort IV) for blood draws at the hospital. Potentially eligible
subjects who decide not to participate in the study will still have access to
the general national SARS-CoV-2 vaccination program.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
-Willing to receive routine COVID-19 vaccination with Pfizer or Moderna vaccine
as part of the national vaccination program (cohort I)
-Having received SARS-CoV-2 vaccination with Pfizer or Moderna as part of the
national vaccination program, with the last vaccination less than 6 weeks
before study entry (Cohort II + cohort III + cohort IV)
-Written informed consent
Exclusion criteria
-History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (e.g. anaphylaxis) to any component of the study
intervention(s).
-Not able to give informed consent (eg language problem, illiteracy)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003388-90-NL |
| CCMO | NL78187.041.21 |
| Other | NL9547 |