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NCT05028374 · REGISTRY CONDITION SEARCH

COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-12-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Observed Response Rate of Anti-SARS-CoV2 Antibody Seroconversion.

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outcome · POSTED

Observed Rate of STRONG POSITIVE Anti-SARS-CoV2 Antibody Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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 Names
    1. Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine
    label
    A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
    type
    OTHER
interventions
  1. arm Group Labels
    1. A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
    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.
    name
    A single "booster" dose of the Moderna mRNA COVID-19 vaccine
    other Names
    1. Covid 19 booster dose
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
119
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
    measure
    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
secondary Outcomes
  1. 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
    measure
    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.
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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        exact text
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        0
      offset unit
      unicode_code_points
      query cond
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      query disease state id
      ds-plasma-cell-neoplasms
      source file
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      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice