Phase 1
Completed N=44
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
Adult Stem Cell Hematopoetic Transplant
Source: ClinicalTrials.gov NCT01215734 ↗
Enrolled (actual)
44
Serious AEs
40.9%
Results posted
Mar 2013
Primary outcomePrimary: 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 — 18; 4; 14; 7 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
18; 4; 14; 7 | — |
| SECONDARY 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 |
12; 5; 10; 5; 10; 6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01215734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.