Back to resultsCOVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
Primary Purpose
Multiple Myeloma, AL Amyloidosis, Chronic Lymphocytic Leukemia
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A single "booster" dose of the Moderna mRNA COVID-19 vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years of age or older
- Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic malignancy (Cohorts 2 or 3).
- Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks prior to enrollment)
- Anti-SARS-CoV2 IgG antibody titer of results less than 1.0 units (Cohorts 1 and 2), or 1.0-1.99 units (Cohort 3). Antibody titers will be measured within 14 days of enrollment.
- If currently receiving potentially immunosuppressive anti-neoplastic therapy for their underlying hematologic condition, a two-week interruption in therapy before and after the booster dose of vaccine is ENCOURAGED BUT NOT REQUIRED (physician discretion).-
Exclusion Criteria:
- Daily corticosteroids at a dose equivalent to Prednisone 20 mg/day or greater during the period two weeks before enrollment to the trial. Intermittent steroid dosing at or above this level is permitted (i.e., weekly dexamethasone dosing as part of myeloma therapy)
- History of previous severe reaction to any available COVID-19 vaccine (defined as any Grade 3 or higher reaction)
- Febrile illness within 3 days of booster dosing.
- Documented SARS-CoV2 infection within 2 weeks of enrollment.
- Less than 3 months post-autologous or allogeneic stem cell transplant (NOTE: transplant between initial standard vaccine administration and enrollment is NOT otherwise grounds for exclusion from participation).
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
Arm Description
The dose of Moderna mRNA vaccine to be administered is the same for all patients in all enrollment cohorts: 0.5 mL administered intramuscularly as a single dose, according to the manufacturer's package insert.
Outcomes
Primary Outcome Measures
Observed response rate of anti-SARS-CoV2 antibody seroconversion.
Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
Secondary Outcome Measures
Observed AEs and SAEs
Safety Assessments for AEs and SAEs will be graded according to CTCAE v4 criteria.
Observed rate of STRONG POSITIVE anti-SARS-CoV2 antibody response
A STRONG POSITIVE response is defined in this trial as an anti-SARS-CoV2 IgG antibody titer of at least 2 S/CO 28 days (+/- 3 days) following vaccine administration
Full Information
NCT ID
NCT05028374
First Posted
August 23, 2021
Last Updated
August 24, 2022
Sponsor
Barbara Ann Karmanos Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05028374
Brief Title
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
Official Title
Phase II Trial Evaluating the Efficacy of Moderna COVID-19 Vaccine Booster Dosing in Patients With Hematologic Malignancies Who Did Not Have an Adequate Response to Prior Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
July 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
To determine whether protective antibody levels increase after booster dosing with the Moderna COVID-19 vaccine in patients diagnosed with Hematologic Malignancies who have low antibody levels after a prior first vaccination with any of the SARS-CoV2 vaccines that were authorized for use in the USA. Researchers will also assess whether the booster dosing with the Moderna COVID-19 vaccine is safe in patients with multiple myeloma, amyloidosis, or other blood cancers.
Detailed Description
The specific hypothesis being tested is that it may be possible to induce a protective humoral immune response with a booster dose of the Moderna COVID-19 vaccine in patients with hematologic malignancies who did not have an adequate response to first vaccination with any of the available COVID-19 vaccines. To test this hypothesis, t a Phase II singlestage trial in which patients with a negative or weak positive anti-SARS-CoV2 IgG antibody test (defined as <1.00 S/CO and 1.00-1.99 S/CO, respectively) will receive a single standard dose of the Moderna COVID-19 vaccine intramuscularly, and then have anti-SARS-CoV2 IgG antibody levels checked 28 days (+/-3 days) later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, AL Amyloidosis, Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
Arm Type
Other
Arm Description
The dose of Moderna mRNA vaccine to be administered is the same for all patients in all enrollment cohorts: 0.5 mL administered intramuscularly as a single dose, according to the manufacturer's package insert.
Intervention Type
Drug
Intervention Name(s)
A single "booster" dose of the Moderna mRNA COVID-19 vaccine
Other Intervention Name(s)
Covid 19 booster dose
Intervention Description
All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.
Primary Outcome Measure Information:
Title
Observed response rate of anti-SARS-CoV2 antibody seroconversion.
Description
Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
Time Frame
28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine
Secondary Outcome Measure Information:
Title
Observed AEs and SAEs
Description
Safety Assessments for AEs and SAEs will be graded according to CTCAE v4 criteria.
Time Frame
Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
Title
Observed rate of STRONG POSITIVE anti-SARS-CoV2 antibody response
Description
A STRONG POSITIVE response is defined in this trial as an anti-SARS-CoV2 IgG antibody titer of at least 2 S/CO 28 days (+/- 3 days) following vaccine administration
Time Frame
measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 years of age or older
Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic malignancy (Cohorts 2 or 3).
Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks prior to enrollment)
Anti-SARS-CoV2 IgG antibody titer of results less than 1.0 units (Cohorts 1 and 2), or 1.0-1.99 units (Cohort 3). Antibody titers will be measured within 14 days of enrollment.
If currently receiving potentially immunosuppressive anti-neoplastic therapy for their underlying hematologic condition, a two-week interruption in therapy before and after the booster dose of vaccine is ENCOURAGED BUT NOT REQUIRED (physician discretion).-
Exclusion Criteria:
Daily corticosteroids at a dose equivalent to Prednisone 20 mg/day or greater during the period two weeks before enrollment to the trial. Intermittent steroid dosing at or above this level is permitted (i.e., weekly dexamethasone dosing as part of myeloma therapy)
History of previous severe reaction to any available COVID-19 vaccine (defined as any Grade 3 or higher reaction)
Febrile illness within 3 days of booster dosing.
Documented SARS-CoV2 infection within 2 weeks of enrollment.
Less than 3 months post-autologous or allogeneic stem cell transplant (NOTE: transplant between initial standard vaccine administration and enrollment is NOT otherwise grounds for exclusion from participation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Zonder, M.D.
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
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