The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.
- Conditions
- Cancer
- Interventions
- Other: Blood sampling
- Registration Number
- NCT05033158
- Lead Sponsor
- University Hospital, Antwerp
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
- Age of 18 years or older
- Oncological or hematological malignancy or history of it
- Life expectancy > 3 months
- Ability to provide informed consent
- Women who are pregnant or breastfeeding
- Immune deficiency not related to cancer or cancer treatment
- Allergy (multiple); to be determined by physician
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cancer patients Blood sampling Level of antibodies against SARS-CoV-2 will be measured in these patients
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (8)
AZ Groeninge
🇧🇪Kortrijk, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
University Hospital Antwerp
🇧🇪Edegem, Antwerp, Belgium
AZ Klina
🇧🇪Brasschaat, Belgium
AZ Sint Jan
🇧🇪Brugge, Belgium
UZ Brussel
🇧🇪Brussels, Belgium
AZ Sint Lucas
🇧🇪Gent, Belgium
UZ Gent
🇧🇪Gent, Belgium