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

Completed

• Conditions: Lymphoma; Myelodysplastic/Myeloproliferative Neoplasms; Nonmalignant Neoplasm; Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Other: Immunoenzyme technique; Biological: trivalent influenza vaccine; Other: Laboratory biomarker analysis

• Registration Number: NCT00964821
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-08-22
• Study First Submitted QC: 2009-08-22
• Study First Posted: 2009-08-25
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-vaccine	Laboratory biomarker analysis	Patients and normal volunteers who have not received the flu vaccine
Non-vaccine	Immunoenzyme technique	Patients and normal volunteers who have not received the flu vaccine
Flu vaccine	Laboratory biomarker analysis	Patients and normal volunteers who have received a flu vaccine
Flu vaccine	trivalent influenza vaccine	Patients and normal volunteers who have received a flu vaccine
Flu vaccine	Immunoenzyme technique	Patients and normal volunteers who have received a flu vaccine

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of influenza or respiratory incidence in patients after vaccination	1 year after vaccination or two years after transplant if not vaccinated.
Impact of graft-vs-host disease on immune reconstitution and vaccine response	1 year after vaccination or two years after transplant if not vaccinated.
Impact of age ≥ 60 years on immune reconstitution of after vaccination	1 year after vaccination or two years after transplant if not vaccinated.
Differences between antibody and cytokine (CD8 and CD4) response	180 days after vaccine in healthy participants. 360 days after vaccine in transplant patients. 2 years after transplant for transplant patients not vaccinated. One time in normal participants not vaccinated.

Trial Locations

Locations (2)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

City of Hope Medical Group; 🇺🇸 Pasadena, California, United States