Completed

NCT Number: NCT01215734

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

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.

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Key information

Conditions

Adult Stem Cell Hematopoetic Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)

Biological

0.5 ml of HD-TIV on visit 1

Standard Dose Trivalent Inactivated Flu Vaccine

Biological

Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.

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

Time frame: Before TIV and 28-42 days after TIV

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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Oct 6, 2010
Registry last updated: Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.