Influenza Vaccine Post Allogeneic Transplant

Not Applicable

Terminated

• Conditions: Hematologic Malignancy; Hematopoietic Stem Cell Transplant
• Interventions: Biological: Influenza vaccine

• Registration Number: NCT01215981
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-06-11
• Results First Submitted QC: 2016-07-07
• Results First Posted: 2016-08-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants Receiving 1 Dose of Vaccine	Influenza vaccine	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.
Participants Receiving 2 Doses of Vaccine	Influenza vaccine	Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With T-Cell Based Immune Response to Vaccine	8 Weeks After Vaccination	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

Name	Time	Method
Number of Subjects With H3 Based Immune Response to Vaccine	8 Weeks After Vaccination	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.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States