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Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04930055
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Utpal P. Davé, Indiana University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goals of this study are to assess vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2) (6), Moderna (mRNA-1273) (7), or the Janssen (Ad26.COV2.S) (8) vaccines under the FDA Emergency Use Authorization (as per the decision of their treating physician judgment and standard of care)

Condition or disease Intervention/treatment
Cancer Biological: COVID-19 Vaccination

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Actual Study Start Date : June 4, 2021
Estimated Primary Completion Date : August 11, 2023
Estimated Study Completion Date : August 11, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
Patients with solid tumors receiving courses of cytotoxic therapy.
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 2
Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 3
Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 4
Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 5
Patients receiving immune checkpoint inhibitors.
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 6
Patients who underwent allogeneic stem cell transplant within 12 months.
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 7
Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 8
Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 9
Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 10
Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 11
Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)
Group 12
Patients who have a cancer diagnosis but do not fall into group 1-11
 Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event Collection [ Time Frame: from date of vaccination until 2 months after full vaccination ]

Secondary Outcome Measures :
  1. Incidence of COVID-19 infection [ Time Frame: from date of vaccination until 6 months after full vaccination ]

Biospecimen Retention:   Samples Without DNA

Serum Collection at 1 and 3 months after Dose 2 for Moderna/Pfizer vaccinations and 1 and 3 months after Dose 1 for Janssen vaccinations.

PBMC Collection at Dose 2,+1 month , +3 months, +6 months and +12 months after their Dose 2 for Pfizer/Moderna vaccinations. Collection at +1 month,+3 months,, +6 months and +12 months after their Dose 1 for Janssen vaccinations

Serum and peripheral blood mononuclear cells (PBMC) will be cryopreserved for molecular and immunologic studies that can include, but are not limited, to antibody titers, cytokines and chemokines, immune cell subsets and T cell and B cell analysis.


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
Sampling Method:   Non-Probability Sample
Study Population
Patients with a current or previous cancer diagnosis
Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent and HIPAA authorization
  2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
  3. Subjects must be ≥ 18 years old at the time of consent.

  4. Diagnosis of cancer and fall into one of the groups below:

    1. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
    2. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
    3. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
    4. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
    5. Group 5: Patients receiving immune checkpoint inhibitors.
    6. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
    7. Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.
    8. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
    9. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
    10. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
    11. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
    12. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11

3. Estimated survival of 8 weeks or more following enrollment on the study.

Exclusion Criteria:

  • 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days

    2. Unwilling or unable to follow protocol requirements.

    3. Subjects who have received any prior COVID-19 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): NCT04930055


Contacts
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Contact: Millicent MacGregor, RN 317-274-5288 milmacgr@iu.edu
Contact: John Spittler, RN (317) 274-0771 ajspittl@iu.edu

Locations
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United States, Indiana
IU Health Joe and Shelly Schwarz Cancer Center Recruiting
Carmel, Indiana, United States, 46032
Contact: John Spittler, RN    317-274-0771    ajspittl@iu.edu   
Principal Investigator: Utpal Dave, MD         
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Millicent MacGregor, RN       milmacgr@iu.edu   
Principal Investigator: Utpal Dave, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Utpal Dave, MD Indiana University
More Information
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Responsible Party: Utpal P. Davé, Associate Professor Department of Medicine Division of Hematology/Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT04930055    
Other Study ID Numbers: CTO-IUSCCC-0759
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Utpal P. Davé, Indiana University:
COVID-19
Vaccine
Pfizer
 Moderna
Janssen
COVID
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections