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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19 and should be at high prioritisation for vaccination against SARS-CoV-2. The COVID-19 vaccine trials have not included cancer patients as such, the efficacy and duration of immunity in patients with cancer are still unknown. Keeping in mind that cancer patients are often immunocompromised, the immune response upon vaccination needs further investigation. The REAL-V is a prospective, multicenter cohort study. The humoral immunity response based on anti-SARS-CoV-2 IgG antibodies upon COVID-19 vaccination will be investigated in blood samples taken 4 months, 6 months and 12 months after (first) vaccine administration. Potential factors that affect immunity, will be recorded, such as type and stage of cancer, anti-cancer treatment, concomitant medication,..To investigate the safety of different COVID-19 vaccines, incidence and severity of systemic adverse events will be reported using an App based system answering questionnaires about specific vaccine related complaints.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling
Blood sampling before and after COVID-19 vaccination

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp KomOpTegenKanker (non-profit organization)

Country where clinical trial is conducted

Belgium, 

Outcome

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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