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

May 17, 2023 updated by: Utpal P. Davé, Indiana University
The goals of this study are to assess initial or booster 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), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • IU Health Joe and Shelly Schwarz Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with a current or previous cancer diagnosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event Collection
Time Frame: from date of vaccination until 2 months after full vaccination
from date of vaccination until 2 months after full vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of COVID-19 infection
Time Frame: from date of vaccination until 6 months after full vaccination
from date of vaccination until 6 months after full vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Utpal Dave, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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