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



Status:Archived
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010
End Date:July 2016

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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


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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