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Vaccination Against COVID-19 in Cancer (VOICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04715438
Recruitment Status : Active, not recruiting
First Posted : January 20, 2021
Last Update Posted : May 31, 2023
Sponsor:
Information provided by (Responsible Party):
Prof.dr. E.G.E. de Vries, University Medical Center Groningen

Study Description
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Brief Summary:
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to counsel patients during the pandemic and support decisions on whom to vaccinate and to identify patients who require other measures to protect them from COVID-19.

Condition or disease Intervention/treatment Phase
Cancer Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 791 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination Against cOvid In CancEr
Actual Study Start Date : January 8, 2021
Actual Primary Completion Date : June 4, 2021
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A: Individuals without cancer
A cohort of individuals without a cancer diagnosis is included for comparison. Because age is an important predictor of the ability to mount an effective immune response to vaccination, partners of patients in cohort B, C, and D.
 Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
All participants will receive two vaccinations against COVID-19 according to standard of care.
Experimental: Cohort B: patients receiving immunotherapy
Cancer patients receiving immunotherapy
 Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
All participants will receive two vaccinations against COVID-19 according to standard of care.
Experimental: Cohort C: patients receiving chemotherapy
Cancer patients receiving chemotherapy
 Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
All participants will receive two vaccinations against COVID-19 according to standard of care.
Experimental: Cohort D: patients receiving chemo-immunotherapy
Cancer patients receiving chemo-immunotherapy
 Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna
All participants will receive two vaccinations against COVID-19 according to standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml [ Time Frame: Measured at 28 days after vaccination ]
    The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination in patients receiving cancer treatment as compared to individuals without cancer. Expressed as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml


Secondary Outcome Measures :
  1. Safety assessment (S)AEs; Incidence and severity of solicited AEs during 7 days after each vaccination with incidence and nature of SAEs reported during 7 days after each vaccination [ Time Frame: During 7 days after vaccination ]
    • Incidence and severity of solicited AEs during 7 days after each vaccination
    • Incidence and nature of SAEs during 7 days after each vaccination

  2. Safety assessment immune related (ir), with incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D reported up to 28 days [ Time Frame: From start till 28 days after second vaccination ]

    - Incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D up to 28 days after the last vaccination graded according to the Common Criteria for Adverse Events version 5.0 (CTCAE v5.0)

    • Neutralizing capacity of antibodies to test functionality
    • Assessment of SARS-CoV2 specific T cells response, 7 days, 28 days, and 6 months after vaccination using a high throughput Interferon ɣ ELIspot.

  3. Safety assessment AE of special interest (SI)s with Incidence, nature and severity of AESIs graded according to CTCAE v5.0 reported up to 12 months after vaccination [ Time Frame: From start till 12 months after vaccination ]
    - Incidence, nature and severity of AESIs graded according to CTCAE v5.0

  4. Assessment of immune response: expressed as geometric mean antibody concentration: arbitrary units (AU)/ml [ Time Frame: measured at 6 to 18 months after vaccination ]
    Persistence of antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml

  5. Assessment of immune response: measured as levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs) [ Time Frame: measured 28 days to 18 months after vaccination ]
    Levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be eligible to participate in this study, a subject must meet all of the following criteria:

  • Age of 18 years or older
  • Life expectancy > 12 months
  • Ability to provide informed consent

Additional criteria for cohort A:

• Partner of a participating patient

Additional criteria for cohort B:

  • Histological diagnosis of a solid malignancy
  • Treatment with monotherapy immune checkpoint inhibitor (ICI) against Programmed Death 1 (PD1) or its ligand PD-L1 (in curative or non-curative setting)
  • Last ICI administration within 3 months of vaccination

Additional criteria for cohort C:

  • Histological diagnosis of a solid malignancy
  • Treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting)
  • Last chemotherapy administration within 4 weeks of vaccination

Additional criteria for cohort D:

  • Histological diagnosis of a solid malignancy
  • Treatment with a PD1 or PD-L1 antibody in combination with cytotoxic chemotherapy (in curative or non-curative setting)
  • Last chemotherapy administration within 4 weeks of vaccination
  • Last ICI administration within 3 months of vaccination

Exclusion criteria:

  • Confirmed SARS-CoV-2 infection (current or previous)
  • Women who are pregnant or breastfeeding
  • Active hematologic malignancy
  • Any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with Human Immunodeficiency Virus)
  • Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. Inhaled or topical steroids, and adrenal replacement steroids (> 10 mg daily prednisone equivalent) are permitted. In addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated CT contrast is allowed.

Additional criteria for cohort A:

  • Current or previous diagnosis of a solid malignancy, unless treated with curative intent >5 years before enrolment and without signs of recurrence during proper follow-up
  • Previous history of a hematologic malignancy

Additional criteria for cohort B:

• Treatment with cytotoxic chemotherapy within 4 weeks of vaccination

Additional criteria for cohort C:

• Treatment with an ICI within 3 months of vaccination

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715438


Locations
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Netherlands
NKI-AvL
Amsterdam, Netherlands
UMCG
Groningen, Netherlands, 9700 RB
Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: E G de Vries, MD, PhD UMCG
  Study Documents (Full-Text)

Documents provided by Prof.dr. E.G.E. de Vries, University Medical Center Groningen:
Study Protocol and Statistical Analysis Plan  [PDF] December 27, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof.dr. E.G.E. de Vries, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04715438    
Other Study ID Numbers: 202000865
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Alignment and reuse Our options for reusing data, biological materials, and/or other resources (from research or practice) in your project.

  • Data: Clinicopathological parameters as described in the protocol
  • Biological materials: Blood
  • Research software: R statistical package, Castor, MOLGENIS
  • Other resources, i.e.,Nederlandse Kankerregistratie (NKR), the Dutch Cancer Registry, electronic patient dossiers (EPDs)

FAIR data within the COVID-19 research community

  • A COVID-19 related or other Findability, Accessibility, Interoperability, and Reuse (FAIR) data points
  • COVID-19 research platform for data sharing

we will make protocol etc. available on the website soon voicetrial.nl
Supporting Materials: Study Protocol
Time Frame: we start the make interim results available second half of 2021
Access Criteria: we aim to share as much as possible also through own website, and COVID-19 platforms that are considered for this kind of research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.dr. E.G.E. de Vries, University Medical Center Groningen:
vaccination
COVID-19
solid tumors
immune response