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NCT Number: NCT04800146

A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).

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Key information

Conditions

Covid19 COVID-19 Cancer Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

About this study

This study will be conducted on 7 cohorts of cancer patients and 1 cohort of non-cancer subjects (age and gender matched) with a sample size of 30 patients in each cohort:

All enrolled patients will be asked to provide blood samples (2 x 10cc Heparin Tubes) at the following time points:

  • Baseline: before the administration of the first dose of the SARS-CoV-2 vaccine (within 4 weeks).
  • Before the second dose of the SARS-CoV-2 vaccine (within 7 days).
  • Follow-up: after 3, 6, 9 and 12 months after the second dose of the SARS-CoV-2 vaccine. A +/- 14 days window is allowed at each follow-up time point.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male of Female age at least 18 years
  • Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Absence of known immune deficiency (other than cancer for cohorts 1-7)
  • Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
  • Willing and able to comply with the study procedures.
  • Willing to receive an mRNA anti-SARS-CoV-2 vaccine.

Treatment and study plan

Blood sample

Procedure

Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination

Primary outcomes

  1. Immune response to SARS-CoV-2 vaccine in cancer patients

    Time frame: 3, 6, 9 and 12 months following vaccination

    to determine the changes in the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens in 7 cohorts of cancer patients who have received the SARS-CoV-2 vaccination. A cohort of non-cancer subjects will be used as control group.

Secondary outcomes

  1. changes in serum antibodies anti SARS-CoV-2 after vaccination

    Time frame: 3, 6, 9 and 12 months following vaccination

    To explore the dynamic changes overtime of the levels of antibodies against SARS-CoV-2 following vaccination in cancer patients and controls

  2. Cellular immune response to SARS-CoV-2 vaccine

    Time frame: 3, 6, 9 and 12 months following vaccination

    To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls.

  3. Cellular immune response to SARS-CoV-2 vaccine

    Time frame: 3, 6, 9 and 12 months following vaccination

    To explore the dynamic changes overtime of the B cells immune response following SARS-CoV-2 vaccination in cancer patients and controls.

  4. Immune response to SARS-CoV-2 vaccine according tumor and treatment type

    Time frame: 3, 6, 9 and 12 months following vaccination

    To explore the correlation between the immune response against SARS-CoV-2 vaccination and the type of cancer (e.g., solid tumors versus hematological malignancies) and the type of anticancer treatment (e.g., anti-CD20, chemotherapy, targeted agents, immunotherapy, allogenic or autologous transplant)

Sponsors and collaborators

Lead sponsor

Ilaria Colombo

Other

Collaborators

  • Ente Ospedaliero Cantonale, Bellinzona
  • Institute for Research in Biomedicine

Registry information

Official study title

A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Mar 23, 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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