NCT00964821

Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant

Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 459 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Studying immune response to flu vaccine in patients who have undergone a stem cell transplant may help doctors plan the best treatment. PURPOSE: This clinical trial is studying flu vaccine to see how well it works in preventing infection in patients who have undergone a stem cell transplant and in healthy volunteers.

Detailed description

OBJECTIVES: * Examine the humoral and cellular memory immune responses to influenza immunization in patients who have undergone autologous or allogeneic hematologic stem cell transplantation. * Examine the impact of graft-vs-host disease on immune reconstitution and vaccine response in these patients. * Examine the impact of age ≥ 60 years on immune reconstitution after vaccination in these patients. * Examine and compare the cellular memory immune response to influenza immunization in healthy volunteers versus the response in these patients. * Examine the differences between CD8, CD4, and antibody response to circulating flu strains compared to immune response to flu vaccination in immunized vs non-immunized patients who were transplanted at a similar time and from the same transplant source. OUTLINE: This is a multicenter study. Patients are stratified according to transplantation type and response (allogeneic HCT with no acute or chronic GVHD vs allogeneic HCT with acute or chronic GVHD vs autologous HCT) and patient age (≥ 60 years vs \< 60 years). Beginning 100-364 days post-transplantation patients receive vaccine to immunize against influenza A serotypes specific for influenza seasons 2006-2008, and/or vaccine to immunize against influenza A and B serotypes specific for influenza seasons 2009-2011. Healthy participants receive vaccine to immunize against influenza A serotypes specific for influenza season 2007-2008. Blood samples from patients and healthy participants are collected at baseline and at days 30, 90, 180, and 360 post-vaccination for humoral immunity and antibody analysis by ELISA and hemagglutination-inhibition test (HAI) testing.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms
• Nonmalignant Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	trivalent influenza vaccine	Patients or normal volunteers who will be vaccinated against the flu.
OTHER	Immunoenzyme technique	This test will determine the level of antibodies in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.
OTHER	Laboratory biomarker analysis	This test will count the number of T cells (the cells that kill the flu virus) in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-08-25
• Last updated: 2017-11-07

Locations

2 sites across 1 country: United States