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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 1

Conditions: Adult Stem Cell Hematopoetic Transplant

Treatments: Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV); Biological: Standard Dose Trivalent Inactivated Flu Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01215734

VICC BMT 1057

100980 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

High-Dose Trivalent Inactivated Influenza Vaccine

Active Comparator group

Description:

Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine

Treatment:

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

Standard dose Trivalent Inactivated Flu Vaccine

Active Comparator group

Description:

Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.

Treatment:

Biological: Standard Dose Trivalent Inactivated Flu Vaccine