Influenza Vaccine Post Allogeneic Transplant

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01215981
• Other study ID #: 2010NTLS050
• Secondary ID: MT2010-08R1007M8
• Status: Terminated
• Phase: N/A
• First received: October 5, 2010
• Last updated: December 3, 2017
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematopoietic Stem Cell Transplant
• Influenza, Human

Intervention

Biological:
• Influenza vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
• Influenza vaccine
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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