The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.
REAL-V
Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
1 other identifier
interventional
402
1 country
8
Brief Summary
This study investigates the immune response in the cancer population in Belgium being vaccinated with an approved vaccine types being authorized for use in Belgium. This question needs to be answered to make sure that this vulnerable population is properly protected against possible SARS-CoV-2 infection and that vaccine administration is safe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Apr 2021
Typical duration for not_applicable cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2023
CompletedJune 15, 2023
June 1, 2023
1.8 years
April 2, 2021
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Immune response
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies 4 months after (first) vaccine administration. Antibody titers to the full Spike, S1, S2, RBD (receptor binding domain) and N (nucleocapsid) protein of SARS-CoV-2 will be measured quantitatively. For this measurement a multiplex SARS-CoV-2 immunoassay will be used.
4 months
Secondary Outcomes (4)
Duration of the immune response
6 months
Neutralizing capacity
6 months
Efficacy of the immune response
12 months
Vaccine safety
12 months
Study Arms (1)
Cancer patients
OTHERLevel of antibodies against SARS-CoV-2 will be measured in these patients
Interventions
Eligibility Criteria
You may qualify if:
- Age of 18 years or older
- Oncological or hematological malignancy or history of it
- Life expectancy \> 3 months
- Ability to provide informed consent
You may not qualify if:
- Women who are pregnant or breastfeeding
- Immune deficiency not related to cancer or cancer treatment
- Allergy (multiple); to be determined by physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Hospital Antwerp
Edegem, Antwerp, Belgium
AZ Klina
Brasschaat, Belgium
AZ Sint Jan
Bruges, Belgium
UZ Brussel
Brussels, Belgium
AZ Sint Lucas
Ghent, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge
Kortrijk, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Peeters, Prof. MD
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2021
First Posted
September 2, 2021
Study Start
April 1, 2021
Primary Completion
December 31, 2022
Study Completion
June 13, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share