Influenza Vaccine Post Allogeneic Transplant

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?

Conditions
-----------------
Hematopoietic Stem Cell Transplant, Hematologic Malignancy

Intervention / Treatment
-----------------
* Biological: Influenza vaccine
* Biological: Influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Participants Receiving 1 Dose of Vaccine<br>Control group participants (healthy volunteers): 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 and/or HSCT recipients who are greater than 60 days post transplant. | Biological: Influenza vaccine<br>* One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B<br>* Other names: Influenza B vaccine;|
| Active Comparator: Participants Receiving 2 Doses of Vaccine<br>Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant. | Biological: Influenza vaccine<br>* Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B<br>* Other names: Influenza B;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 Weeks After Vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 Weeks After Vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza vaccine