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)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Blood sampling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brasschaat, Belgium
    • AZ Klina
  • Brugge, Belgium
    • AZ Sint Jan
  • Brussels, Belgium
    • UZ Brussel
  • Gent, Belgium
    • UZ Gent
  • Gent, Belgium
    • AZ Sint Lucas
  • Kortrijk, Belgium
    • AZ Groeninge
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
  • Antwerp
    • Edegem, Antwerp, Belgium
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cancer patients; Level of antibodies against SARS-CoV-2 will be measured in these patients	Other: Blood sampling; Blood sampling before and after COVID-19 vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Neutralizing capacity	To analyze the titer of neutralizing antibodies both 4 and 6 months after (first) vaccine administration	6 months
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: KomOpTegenKanker (non-profit organization)
• Investigators: Principal Investigator: Marc Peeters, Prof. MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 001752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No