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Summary

for people ages 3–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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:

  1. 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:

  1. 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.

  1. 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.

VIII. To assess HAI and MN response in children vaccinated during year 1 and revaccinated during year 2 using the same antigen dose.

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 Neoplasms Vaccines

Eligibility

For people ages 3–17

FOR YEAR 2:

  1. A target of at least 200 pediatric patients who received an allogeneic HSCT
  2. Inclusion criteria
  3. Allogeneic HSCT recipients who are 3-35 months post-transplant;
  4. 3-17 years of age, inclusive;
  5. Available for duration of study;
  6. If patients are on immunosuppressive therapy for treatment of GVHD, then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible;
  7. Parent/legal guardian willing and capable of signing written informed consent;
  8. Parent/legal guardian expected to be available for entire study;
  9. Parent/legal guardian can be reached by telephone or email.
  10. 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, or platelet count ≥75,000 without transfusion documented within 30 days for subjects <12 months post-transplant and within 90 days for subjects 12-35 months post-transplant.
  11. Recipients of CD34 selected grafts or other manipulated grafts (with any form of ex vivo T cell depletion) will be eligible to enroll if they have a CD3 count>100. (Please note: post-transplant cytoxan for haploidentical transplants is allowable).
  12. Exclusion criteria
  13. History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein;
  14. History of Guillain-Barre syndrome;
  15. Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted);
  16. History of receiving current year seasonal influenza vaccine influenza vaccine;
  17. Pregnant female;
  18. History of proven influenza disease after September 1, 2017
  19. Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients;
  20. History of known active infection with HIV, Hepatitis B or Hepatitis C;
  21. History of known severe latex hypersensitivity;
  22. Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
  23. Receipt of IVIG <27 days prior to calendar day of vaccination Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible: 1).Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of enrollment 2). Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks of study vaccination.
  24. For the 31 subjects enrolled in year 1, inclusion and exclusion criteria include:
  25. Inclusion criteria
  26. If patients are on immunosuppressive therapy for treatment of GVHD, then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible;
  27. 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, or platelet count ≥75,000 without transfusion documented within 30 days for subjects <12 months post-transplant and within 90 days for subjects 12-35 months post-transplant.
  28. Recipients of CD34 selected grafts or other manipulated grafts (with any form of ex vivo T cell depletion) will be eligible to enroll if they have a CD3 count>100. (Please note: post-transplant cytoxan for haploidentical transplants is allowable).
  29. Exclusion criteria
  30. Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted);
  31. History of receiving current year seasonal influenza vaccine influenza vaccine;
  32. Pregnant female;
  33. History of proven influenza disease after September 1, 2017
  34. History of known active infection with HIV, Hepatitis B or Hepatitis C;
  35. Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
  36. Receipt of IVIG <27 days prior to calendar day of vaccination

Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible: 1). Fever ≥100.4ºF/38.0ºC(oral measurement), or an acute illness within 48 hours of enrollment 2). Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks of study vaccination.

Locations

  • UCSF Children's Hospital accepting new patients
    San Francisco, California, 94158, United States
  • Seattle Children's Hospital Research Institute accepting new patients
    Seattle, Washington, 98101, United States
  • Children's Mercy Hospital accepting new patients
    Kansas City, Missouri, 64108, United States
  • Texas Children's Hospital accepting new patients
    Houston, Texas, 77030, United States
  • St. Jude Children's Research Hospital accepting new patients
    Memphis, Tennessee, 38105, United States
  • Vanderbilt-Ingram Cancer Center accepting new patients
    Nashville, Tennessee, United States
  • Cincinnati Children's Hospital accepting new patients
    Cincinnati, Ohio, 45229, United States
  • Nationwide Children's Hospital accepting new patients
    Columbus, Ohio, 43205, United States
  • Children's Hospital of Philadelphia accepting new patients
    Philadelphia, Pennsylvania, 19104, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt-Ingram Cancer Center
ID
NCT02860039
Phase
Phase 2
Study Type
Interventional
Last Updated
April 12, 2018