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Completed

NCT Number: NCT05033158

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

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp, Edegem, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Blood sampling before and after COVID-19 vaccination

Primary outcomes

  1. Immune response

    Time frame: 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 outcomes

  1. Duration of the immune response

    Time frame: 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.

  2. Neutralizing capacity

    Time frame: 6 months

    To analyze the titer of neutralizing antibodies both 4 and 6 months after (first) vaccine administration

  3. Efficacy of the immune response

    Time frame: 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.

  4. Vaccine safety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • KomOpTegenKanker (non-profit organization)

Registry information

Official study title

Investigation to Reveal the Immune Reaction Upon COVID-19 Vaccination in the Belgian Cancer Population: COVID-19 Protection and Vaccine Safety (REAL-V)

Acronym: REAL-V

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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