Clinical trial NCT05033158: The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.
Official title: Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: KomOpTegenKanker (non-profit organization)
First posted: 2021-09-02
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immune response
timeFrame: 4 months
Secondary outcomes:
measure: Duration of the immune response
timeFrame: 6 months
measure: Neutralizing capacity
timeFrame: 6 months
measure: Efficacy of the immune response
timeFrame: 12 months
measure: Vaccine safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: AZ Sint Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: University Hospital, Antwerp
name: Marc Peeters, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: