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出境医 / 临床实验 / Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Study Description
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
| 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 |
Arms 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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
Outcome Measures
Primary Outcome Measures :
- Adverse Event Collection [ Time Frame: from date of vaccination until 2 months after full vaccination ]
Secondary Outcome Measures :
- 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
| 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:
- Ability to provide written informed consent and HIPAA authorization
- Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
- Subjects must be ≥ 18 years old at the time of consent.
-
Diagnosis of cancer and fall into one of the groups below:
- Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
- Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
- Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
- Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
- Group 5: Patients receiving immune checkpoint inhibitors.
- Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
- 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.
- Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
- Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
- Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
- Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
- 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
Contacts
| Contact: Millicent MacGregor, RN | 317-274-5288 | milmacgr@iu.edu | |
| Contact: John Spittler, RN | (317) 274-0771 | ajspittl@iu.edu |
Locations
| 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
| Principal Investigator: | Utpal Dave, MD | Indiana University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 15, 2021 | ||||||||
| First Posted Date | June 18, 2021 | ||||||||
| Last Update Posted Date | June 18, 2021 | ||||||||
| Actual Study Start Date | June 4, 2021 | ||||||||
| Estimated Primary Completion Date | August 11, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Adverse Event Collection [ Time Frame: from date of vaccination until 2 months after full vaccination ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Incidence of COVID-19 infection [ Time Frame: from date of vaccination until 6 months after full vaccination ] | ||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC) | ||||||||
| Official Title | Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC) | ||||||||
| 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) | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
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. |
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with a current or previous cancer diagnosis | ||||||||
| Condition | Cancer | ||||||||
| Intervention | 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:
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
240 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 11, 2023 | ||||||||
| Estimated Primary Completion Date | August 11, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
3. Estimated survival of 8 weeks or more following enrollment on the study. Exclusion Criteria:
|
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| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04930055 | ||||||||
| Other Study ID Numbers | CTO-IUSCCC-0759 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Utpal P. Davé, Indiana University | ||||||||
| Study Sponsor | Indiana University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
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| PRS Account | Indiana University | ||||||||
| Verification Date | June 2021 | ||||||||