search
Back to results

Influenza Vaccine Post Allogeneic Transplant

Primary Purpose

Hematopoietic Stem Cell Transplant, Hematologic Malignancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccine
Influenza vaccine
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematopoietic Stem Cell Transplant focused on measuring influenza vaccine

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Participants Receiving 1 Dose of Vaccine

Participants Receiving 2 Doses of Vaccine

Arm Description

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.

Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2010
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT01215981
Brief Title
Influenza Vaccine Post Allogeneic Transplant
Official Title
MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients and no longer influenza vaccine season.
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplant, Hematologic Malignancy
Keywords
influenza vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants Receiving 1 Dose of Vaccine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Participants Receiving 2 Doses of Vaccine
Arm Type
Active Comparator
Arm Description
Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Other Intervention Name(s)
H1N1, H3N2, Influenza A vaccine, Influenza B vaccine
Intervention Description
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Other Intervention Name(s)
Influenza A, H1N1, N3N2, Influenza B
Intervention Description
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Primary Outcome Measure Information:
Title
Number of Subjects With T-Cell Based Immune Response to Vaccine
Description
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 Outcome Measure Information:
Title
Number of Subjects With H3 Based Immune Response to Vaccine
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Verneris, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Links:
URL
http://dx.doi.org/10.1016/j.bbmt.2012.08.015
Description
Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic Transplantation

Learn more about this trial

Influenza Vaccine Post Allogeneic Transplant

We'll reach out to this number within 24 hrs