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Eligibility
for people ages 3 years to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

Official Title

Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients

Details

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To determine whether HD-TIV compared with standard dose 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 pediatric 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 standard QIV in pediatric 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 standard dose QIV in pediatric 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 pediatric HSCT recipients receiving either HD-TIV or standard dose QIV.

V. To correlate HAI responses to microneutralization responses.

VI. To compare the persistent HAI and microneutralization (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 PCR during influenza season in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

GROUP I (Experimental): Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.

GROUP II (Standard): Patients receive standard dose QIV IM on day 0 and day 28.

After completion of study treatment, patients are followed up at 28-42 days, and at 7 months.

Keywords

Hematopoietic Cell Transplantation Recipient Malignant Neoplasm Influenza Vaccines

Eligibility

You can join if…

Open to people ages 3 years to 17 years

  • Allogeneic HSCT recipients who are 3-35 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
  • Parent/legal guardian willing and capable of signing written informed consent
  • Parent/legal guardian expected to be available for entire study
  • Parent/legal guardian can be reached by telephone or email
  • 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 12-35 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.

You CAN'T join if...

  • 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 is permitted)
  • History of receiving 2016-2017 influenza vaccine
  • Pregnant female
  • History of proven influenza disease after September 1, 2016
  • Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant(SCT) recipients
  • Platelet count less than 30,000 cells/uL
  • 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
  • C34 selection or other ex-vivo T-cell depletion, post-transplant cytoxan for aploidentical transplants is allowable.

Locations

  • Children's Mercy Hospital accepting new patients
    Kansas City, Missouri, 64108, USA
  • Cincinnati Children's Hospital accepting new patients
    Cincinnati, Ohio, 45229, USA
  • Nationwide Children's Hospital accepting new patients
    Columbus, Ohio, 43205, USA
  • Children's Hospital of Philadelphia accepting new patients
    Philadelphia, Pennsylvania, 19104, USA
  • St. Jude Children's Research Hospital accepting new patients
    Memphis, Tennessee, 38105, USA
  • Vanderbilt-Ingram Cancer Center accepting new patients
    Nashville, Tennessee, USA
  • Texas Children's Hospital accepting new patients
    Houston, Texas, 77030, USA
  • Seattle Children's Hospital Research Institute accepting new patients
    Seattle, Washington, 98101, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt-Ingram Cancer Center
ID
NCT02860039
Phase
Phase 2
Lead Scientist
Rachel Wattier
Study Type
Interventional
Last Updated
January 2017