Influenza Vaccine Post Allogeneic Transplant

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

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 Overview

• Status: Terminated
• Conditions: Hematologic Malignancy; Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Biological: Influenza vaccine; Biological: Influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants Receiving 1 Dose of 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.	Biological: Influenza vaccine; One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B; Other Names: H1N1; H3N2; Influenza A vaccine; Influenza B vaccine; Biological: Influenza vaccine; Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B; Other Names: H1N1; Influenza A; N3N2; Influenza B
Active Comparator: Participants Receiving 2 Doses of Vaccine; Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.	Biological: Influenza vaccine; One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B; Other Names: H1N1; H3N2; Influenza A vaccine; Influenza B vaccine; Biological: Influenza vaccine; Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B; Other Names: H1N1; Influenza A; N3N2; 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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Michael Verneris, M.D., Masonic Cancer Center, University of Minnesota

Publications and helpful links

Helpful Links

• Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic Transplantation

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Orthomyxoviridae Infections; Hematologic Neoplasms; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2010NTLS050; MT2010-08R (Other Identifier: Blood and Bone Marrow Transplantation Program); 1007M86296 (Other Identifier: IRB, University of Minnesota)