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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: -…
ID
NL-OMON21465
Source
NTR
Brief title
VACCinATE
Condition
- Viral infectious disorders
Synonym
Childhood cancer, Corona vaccination, immune response
Health condition
Research involving
Human
Sponsors and support
Primary sponsor
:
Princess Máxima Center for Pediatric Oncology
Source(s) of monetary or material Support
:
Core research funding
Intervention
Explanation
Outcome measures
Primary outcome
Secondary outcome
-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
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
-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
Intervention
Study burden and risks
Public
Prinses Máxima Centrum voor Kinderoncologie
Prof. Dr. W.J.E. Tissing
Prinses Máxima Centrum
Heidelberglaan 25
3584 CS
Utrecht
Nederland
088 972 72 72
trialmanager@prinsesmaximacentrum.nl
Prof. Dr. W.J.E. Tissing
Prinses Máxima Centrum
Heidelberglaan 25
3584 CS
Utrecht
Nederland
088 972 72 72
trialmanager@prinsesmaximacentrum.nl
Scientific
Prinses Máxima Centrum voor Kinderoncologie
Prof. Dr. W.J.E. Tissing
Prinses Máxima Centrum
Heidelberglaan 25
3584 CS
Utrecht
Nederland
088 972 72 72
trialmanager@prinsesmaximacentrum.nl
Prof. Dr. W.J.E. Tissing
Prinses Máxima Centrum
Heidelberglaan 25
3584 CS
Utrecht
Nederland
088 972 72 72
trialmanager@prinsesmaximacentrum.nl
Age
Babies and toddlers (28 days-23 months)
Babies and toddlers (28 days-23 months)
Children (2-11 years)
Children (2-11 years)
Adolescents (12-15 years)
Adolescents (12-15 years)
Adolescents (16-17 years)
Adolescents (16-17 years)
Inclusion criteria
- Having received SARS-CoV-2 vaccination with Pfizer or Moderna as part of the national vaccination program,with the last vaccination less
Exclusion criteria
- Not able to give informed consent (eg language problem, illiteracy)
Design
Study phase
:
4
Study type
:
Observational non invasive
Intervention model
:
Single
Allocation
:
Non controlled trial
Masking
:
Open (masking not used)
Control
:
N/A , unknown
Primary purpose
:
Prevention
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
130
Type
:
Actual
IPD sharing statement
Plan to share IPD
:
Undecided
Plan description
None
Approved WMO
Date
:
Application type
:
First submission
Review commission
:
METC NedMec
Followed up by the following (possibly more current) registration
ID: 52106
Bron: ToetsingOnlineOther (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9547 |
CCMO | NL78187.041.21 |
EudraCT | 2021-003388-90 |
OMON | NL-OMON52106 |
Summary results
Will follow