Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05028374
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma AL Amyloidosis Chronic Lymphocytic Leukemia Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : July 21, 2022
Estimated Study Completion Date : July 21, 2023


Arm Intervention/treatment
A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
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.
Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine
All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.
Other Name: Covid 19 booster dose




Primary Outcome Measures :
  1. Observed response rate of anti-SARS-CoV2 antibody seroconversion. [ Time Frame: 28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine ]
    Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.


Secondary Outcome Measures :
  1. Observed AEs and SAEs [ Time Frame: Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination. ]
    Safety Assessments for AEs and SAEs will be graded according to CTCAE v4 criteria.

  2. Observed rate of STRONG POSITIVE anti-SARS-CoV2 antibody response [ Time Frame: measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine. ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 years of age or older
  4. Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic malignancy (Cohorts 2 or 3).
  5. Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks prior to enrollment)
  6. 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.
  7. 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:

  1. 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)
  2. History of previous severe reaction to any available COVID-19 vaccine (defined as any Grade 3 or higher reaction)
  3. Febrile illness within 3 days of booster dosing.
  4. Documented SARS-CoV2 infection within 2 weeks of enrollment.
  5. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028374


Contacts
Layout table for location contacts
Contact: Cathy Galasso, RN 313-576-8453 galassoc@karmanos.org
Contact: Jeffrey Zonder, MD 313-576-8673 zonderj@karmanos.org

Locations
Layout table for location information
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey A. Zonder    313-576-9363    zonderj@karmanos.org   
Principal Investigator: Jeffrey A. Zonder, M.D.         
Sub-Investigator: Abhinav Deol, M.D.         
Sub-Investigator: Jay Yang, M.D.         
Sub-Investigator: Melissa Runge-Moris, M.D.         
Sub-Investigator: Asif Alavi, M.D.         
Sub-Investigator: Andrew Kin, M.D.         
Sub-Investigator: Asfar Azmi, PhD         
Sub-Investigator: Joseph Uberti, M.D.         
Sub-Investigator: Lois Ayash, M.D.         
Sub-Investigator: Dipenkumar Modi, M.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey A. Zonder, M.D. Barbara Ann Karmanos Cancer Institute
Layout table for additonal information
Responsible Party: Jeffrey Zonder, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT05028374    
Other Study ID Numbers: 2021-036
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Lymphatic Diseases
Leukemia, B-Cell
Neoplasms by Site
Proteostasis Deficiencies
Metabolic Diseases