Clinical trial NCT04930055: Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Official title: Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: COVID-19
Vaccine
Pfizer
Moderna
Janssen
COVID
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 2206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a current or previous cancer diagnosis

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Adverse Event Collection
timeFrame: from date of vaccination until 2 months after full vaccination
Secondary outcomes:
measure: Incidence of COVID-19 infection
timeFrame: from date of vaccination until 6 months after full vaccination
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU Health Joe and Shelly Schwarz Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Utpal Dave, MD
role: PRINCIPAL_INVESTIGATOR
References: