Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
- Examine the humoral and cellular memory immune responses to influenza immunization in
patients who have undergone autologous or allogeneic hematologic stem cell
- 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
- 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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Humoral and cellular memory immune responses in patients and healthy volunteers
At Day 0 and 30, 90 and 180 days after vaccine in healthy participants and also at 360 days in transplant patients . 4-5 times in the first 2 years after transplant for transplant patients not vaccinated. One time in normal participants not vaccinated.
Don Diamond, PhD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|