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

Indiana University

Status: Terminated

Conditions: Cancer

Treatments: Biological: COVID-19 Vaccination

Study type: Observational

Funder types: Other

Identifiers

NCT04930055

CTO-IUSCCC-0759

Details and patient eligibility

About

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.

Enrollment: 2,206 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

5. 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.

Trial design

2,206 participants in 12 patient groups

Group 1

Description:

Patients with solid tumors receiving courses of cytotoxic therapy.

Treatment:

Biological: COVID-19 Vaccination

Group 2

Description:

Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

Treatment:

Biological: COVID-19 Vaccination

Group 3

Description:

Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

Treatment:

Biological: COVID-19 Vaccination

Group 4

Description:

Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

Treatment:

Biological: COVID-19 Vaccination

Group 5

Description:

Patients receiving immune checkpoint inhibitors.

Treatment:

Biological: COVID-19 Vaccination

Group 6

Description:

Patients who underwent allogeneic stem cell transplant within 12 months.

Treatment:

Biological: COVID-19 Vaccination

Group 7

Description:

Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.

Treatment:

Biological: COVID-19 Vaccination

Group 8

Description:

Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches

Treatment:

Biological: COVID-19 Vaccination

Group 9

Description:

Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).

Treatment:

Biological: COVID-19 Vaccination

Group 10

Description:

Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

Treatment:

Biological: COVID-19 Vaccination

Group 11

Description:

Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

Treatment:

Biological: COVID-19 Vaccination

Group 12

Description:

Patients who have a cancer diagnosis but do not fall into group 1-11

Treatment:

Biological: COVID-19 Vaccination