The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-06-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cancer patients

Level of antibodies against SARS-CoV-2 will be measured in these patients

Group Type OTHER

Blood sampling

Intervention Type OTHER

Blood sampling before and after COVID-19 vaccination

Interventions

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Blood sampling

Blood sampling before and after COVID-19 vaccination

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No