Trials / Completed
CompletedNCT05033158
The Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population.
Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 402 (actual)
- Sponsor
- University Hospital, Antwerp · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood sampling | Blood sampling before and after COVID-19 vaccination |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-12-31
- Completion
- 2023-06-13
- First posted
- 2021-09-02
- Last updated
- 2023-06-15
Locations
8 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05033158. Inclusion in this directory is not an endorsement.