Cancer Clinical Trial
— REAL-VOfficial title:
Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
NCT number | NCT05033158 |
Other study ID # | 001752 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | June 13, 2023 |
Verified date | June 2023 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 402 |
Est. completion date | June 13, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of 18 years or older - Oncological or hematological malignancy or history of it - Life expectancy > 3 months - Ability to provide informed consent Exclusion Criteria: - Women who are pregnant or breastfeeding - Immune deficiency not related to cancer or cancer treatment - Allergy (multiple); to be determined by physician |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Klina | Brasschaat | |
Belgium | AZ Sint Jan | Brugge | |
Belgium | UZ Brussel | Brussels | |
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Belgium | AZ Sint Lucas | Gent | |
Belgium | UZ Gent | Gent | |
Belgium | AZ Groeninge | Kortrijk | |
Belgium | AZ Nikolaas | Sint-Niklaas |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | KomOpTegenKanker (non-profit organization) |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Duration of the immune response | To study the evolution and duration of the immune response after vaccination: using serological assays to analyze anti-RBD IgG titers 6 months after (first) vaccine administration. | 6 months | |
Secondary | Neutralizing capacity | To analyze the titer of neutralizing antibodies both 4 and 6 months after (first) vaccine administration | 6 months | |
Secondary | Efficacy of the immune response | This will be assessed by the SARS-Cov2 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARSCoV-2 infection within a time-frame of 12 months after the start of the study. | 12 months | |
Secondary | Vaccine safety | Safety will be reported in terms of incidence and severity of systemic adverse events (AEs) during a continuous App based reporting system or using a questionnaire 3 days after vaccine administration. | 12 months |
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