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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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
Outcomes
Primary Outcomes
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
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 Outcomes
- 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(Before TIV and 28-42 days after TIV)
Investigators
Natasha Halasa, MD
Assistant Professor of Pediatrics, Pediatric Infectious Diseases
Vanderbilt-Ingram Cancer Center