Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

Sponsor
Emory University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04080531
Collaborator
Sanofi (Industry)
165
2
2
36.4
82.5
2.3

Study Details

Study Description

Brief Summary

This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pneumococcal 13-valent Conjugate Vaccine
  • Biological: Trivalent Influenza Vaccine
Phase 4

Detailed Description

PRIMARY OBJECTIVES:
  1. Demonstrate an absolute 25% increase in seroprotection, defined as hemagglutination antibody inhibition (HAI) > 40 against all strains, at week 21 in the experimental arm compared to the control arm.

  2. Determine correlation between HAI, predefined risk of influenza-like illness (low, moderate, high), and progression-free survival (PFS).

EXPLORATORY OBJECTIVES:
  1. Measurement of B & T-cell subsets and flu-specific responses as a way of understanding immunosuppression in this patient population, correlating with influenza-like illness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive trivalent influenza vaccine intramuscularly (IM) at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks and then periodically for 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Influenza Vaccination in Plasma Cell Dyscrasias
Actual Study Start Date :
Oct 18, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (trivalent influenza vaccine, Prevnar)

Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

Biological: Pneumococcal 13-valent Conjugate Vaccine
Given IM
Other Names:
  • PCV13
  • Prevnar 13
  • Biological: Trivalent Influenza Vaccine
    Given IM
    Other Names:
  • Flu shot
  • Flu vaccination
  • Fluzone
  • Fluzone HD
  • Fluzone High-dose
  • Influenza Vaccine
  • Influenza Virus Vaccine, Trivalent, Types A and B
  • TIV
  • Experimental: Arm II (trivalent influenza vaccine, Prevnar)

    Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

    Biological: Pneumococcal 13-valent Conjugate Vaccine
    Given IM
    Other Names:
  • PCV13
  • Prevnar 13
  • Biological: Trivalent Influenza Vaccine
    Given IM
    Other Names:
  • Flu shot
  • Flu vaccination
  • Fluzone
  • Fluzone HD
  • Fluzone High-dose
  • Influenza Vaccine
  • Influenza Virus Vaccine, Trivalent, Types A and B
  • TIV
  • Outcome Measures

    Primary Outcome Measures

    1. Change in hemagglutination antibody inhibition (HAI) from baseline [21 weeks]

      Assess change in HAI in blood from baseline compared to week 21

    Secondary Outcome Measures

    1. Time to progression (TTP) [From last treatment until progression, assessed up to 2 years]

      Time to progression is defined as the time from last treatment until progression. Patients who have died without evidence of progression are censored in the TTP analysis at the time of death and patients who are alive without progression are censored at the last disease assessment.

    2. Progression free survival (PFS) [From last treatment to the disease progression or death from any cause, assessed up to 2 years]

      Defined as the time from last treatment to the disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. Patients with no on-study assessment will be censored at the time of registration.

    3. Overall survival (OS) [From randomization to death, assessed up to 2 years]

      OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.

    • Both men and women of all races and ethnic groups are eligible for this study.

    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.

    • Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products.

    • Ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:
    • Patients who have already received the seasonal influenza vaccine in the current season.

    • History of Guillain-Barré syndrome.

    • Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13).

    • Expected survival < 9 months.

    • Prisoners.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Midtown Atlanta Georgia United States 30308
    2 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University
    • Sanofi

    Investigators

    • Principal Investigator: Craig Hofmeister, MD, MPH, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Craig Hofmeister, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT04080531
    Other Study ID Numbers:
    • IRB00111721
    • NCI-2019-03734
    • Winship4709-19
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022