Purpose

This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Allogeneic HSCT recipients who are 3-23 months post-transplant
  • Available for duration of study
  • If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible
  • Can be reached by telephone or email
  • Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization; for subjects < 12 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 14 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization; for subjects 12-23 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 90 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization

Exclusion Criteria

  • History of hypersensitivity to previous influenza vaccination or severe or moderate hypersensitivity to eggs/egg protein
  • History of Guillain-Barre syndrome
  • Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms are permitted)
  • History of receiving 2017-2018 influenza vaccine
  • Pregnant female
  • History of proven influenza disease after September 1, 2017
  • Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients
  • History of known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • History of known latex hypersensitivity
  • Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
  • Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to vaccination
  • CD34 selection or total cell depletion outside haploidentical transplants

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (HD-TIV)
Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Trivalent Influenza Vaccine
    Given intramuscularly
Active Comparator
Group 1(SD-QIV)
Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.
  • Biological: Quadrivalent Inactivated Influenza Vaccine
    Given intramuscularly
  • Other: Laboratory Biomarker Analysis
    Correlative studies

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Clinical Trials Reporting Program
800-811-8480

More Details

NCT ID
NCT03179761
Status
Recruiting
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

Clinical Trials Reporting Program
800-811-8480
cip@vanderbilt.edu

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination inhibition assay (HAI) titer, >= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.

SECONDARY OBJECTIVES:

I. To determine whether HD-TIV compared with SD-QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in adult HSCT recipients.

II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/tenderness, redness, and swelling at injection site) with HD-TIV compared to SD-QIV in adult HSCT recipients.

III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to SD-QIV in adult HSCT recipients.

IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in adult HSCT recipients receiving either HD-TIV or SD-QIV.

V. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.

VII. To compare influenza detection by polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.

GROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.

After completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.