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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Recruiting

CT.gov ID

NCT05033158

Collaborator

KomOpTegenKanker (non-profit organization) (Other)

3,000

Enrollment

Locations

Arm

Anticipated Duration (Months)

375

Patients Per Site

17.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Blood sampling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Immune response [4 months]
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.

Secondary Outcome Measures

Duration of the immune response [6 months]
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.
Neutralizing capacity [6 months]
To analyze the titer of neutralizing antibodies both 4 and 6 months after (first) vaccine administration
Efficacy of the immune response [12 months]
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.
Vaccine safety [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	University Hospital Antwerp	Edegem	Antwerp	Belgium
2	AZ Klina	Brasschaat		Belgium
3	AZ Sint Jan	Brugge		Belgium
4	UZ Brussel	Brussels		Belgium
5	AZ Sint Lucas	Gent		Belgium
6	UZ Gent	Gent		Belgium
7	AZ Groeninge	Kortrijk		Belgium
8	AZ Nikolaas	Sint-Niklaas		Belgium

Sponsors and Collaborators

University Hospital, Antwerp
KomOpTegenKanker (non-profit organization)

Investigators

Principal Investigator: Marc Peeters, Prof. MD, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Antwerp

ClinicalTrials.gov Identifier:

NCT05033158

Other Study ID Numbers:

001752

First Posted:

Sep 2, 2021

Last Update Posted:

Sep 2, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 2, 2021