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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

More Details

NCT ID
NCT04930055
Status
Terminated
Sponsor
Indiana University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.