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Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01215734
First received: October 5, 2010
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV.

  • Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients.

Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.

  • Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.

Condition Intervention Phase
Adult Stem Cell Hematopoetic Transplant
Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
Biological: Standard Dose Trivalent Inactivated Flu Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients [ Time Frame: Day of TIV to 7 days after TIV ] [ Designated as safety issue: Yes ]
    Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.


Secondary Outcome Measures:
  • Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses [ Time Frame: Before TIV and 28-42 days after TIV ] [ Designated as safety issue: No ]
    Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus


Enrollment: 44
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-Dose Trivalent Inactivated Influenza Vaccine
Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine
Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
0.5 ml of HD-TIV on visit 1
Active Comparator: Standard dose Trivalent Inactivated Flu Vaccine
Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.
Biological: Standard Dose Trivalent Inactivated Flu Vaccine
Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allogeneic hematopoietic stem cell transplant recipients who are >6 post-transplant
  • greater than or equal to 18 years of age
  • Available for duration of study
  • If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.

Exclusion Criteria:

  • History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein
  • History of Guillain-Barre syndrome
  • Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
  • Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
  • History of receiving 2011 - 2012 influenza vaccine
  • History of proven influenza disease after September 1, 2011.
  • Pregnant females
  • Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol
  • Have any condition that the investigator believes may interfere with successful completion of the study
  • Platelet count less than 50,000 cells/μL
  • History of known infection with HIV, Hepatitis B or Hepatitis C
  • History of known latex hypersensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215734

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Natasha Halasa, M.D., M.P.H. Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Natasha Halasa, MD, Assistant Professor of Pediatrics, Pediatric Infectious Diseases, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01215734     History of Changes
Other Study ID Numbers: VICC BMT 1057, 100980, 100980
Study First Received: October 5, 2010
Results First Received: February 4, 2013
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014