Influenza Vaccine Post Allogeneic Transplant

Masonic Cancer Center, University of Minnesota68 enrolled

Overview

Study Design: This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hematopoietic Stem Cell Transplant Hematologic Malignancy

Interventions

Influenza vaccineBIOLOGICAL

One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B

Influenza vaccineBIOLOGICAL

Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B

Eligibility

Sex: ALLMin age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient Population * HSCT recipients who are greater than 60 days post transplant. * Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant * Show neutrophil recovery, platelet count \> 50,000/mm3 (may be transfused), no known disease relapse * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome * No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months * Controls: * Age 18 to 50 years * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome * No flu vaccine in previous 4 months

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Number of Subjects With T-Cell Based Immune Response to Vaccine

The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.

Time frame: 8 Weeks After Vaccination

Secondary Outcomes

Number of Subjects With H3 Based Immune Response to Vaccine

The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.

Time frame: 8 Weeks After Vaccination

Data from ClinicalTrials.gov

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