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

November 3, 2017 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

459

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Pasadena, California, United States, 91105
        • City of Hope Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stem cell donors, Autologous and Allogeneic HCT patients, Normal volunteers

Description

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Patient at the City of Hope or Kaiser hospital who underwent prior autologous or allogeneic matched-related hematologic stem cell transplantation (HSCT) or matched-unrelated HSCT for treatment of hematological malignancies, including aplastic anemia or myelodysplastic syndromes

      • Eligible (in accordance with physician's recommendation) to receive the vaccine influenza A serotypes specific for the 2006-2007 or 2007-2008 influenza season

      • Eligible (in accordance with physician's recommendation) to receive the vaccine influenza A or B serotypes specific for the 2009-2010 or 2010-2011 influenza season

        • Patients who are not vaccinated are followed under the study protocol once they are matched to a vaccinated patient on the date of transplant and source of transplant
      • All HLA serotypes allowed

    • Employee volunteer from the City of Hope

      • Meets the requirements for influenza vaccination
      • Eligible to receive the CDC recommended vaccine for influenza A serotypes specific for the 2007-2008 flu season as part of occupational health's vaccination initiative
      • All HLA serotypes allowed

PATIENT CHARACTERISTICS:

  • Life expectancy > 9 months
  • No HIV seropositivity

  • No hepatitis B or C seropositivity

    • Hepatitis B-positive serology by vaccination allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior influenza vaccination after transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flu vaccine
Patients and normal volunteers who have received a flu vaccine
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.
Non-vaccine
Patients and normal volunteers who have not received the flu vaccine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Humoral and cellular memory immune responses in patients and healthy volunteers
Time Frame: 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.
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

Outcome Measure
Time Frame
Incidence rate of influenza or respiratory incidence in patients after vaccination
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
1 year after vaccination or two years after transplant if not vaccinated.
Impact of graft-vs-host disease on immune reconstitution and vaccine response
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
1 year after vaccination or two years after transplant if not vaccinated.
Impact of age ≥ 60 years on immune reconstitution of after vaccination
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
1 year after vaccination or two years after transplant if not vaccinated.
Differences between antibody and cytokine (CD8 and CD4) response
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Don Diamond, PhD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 22, 2009

First Submitted That Met QC Criteria

August 22, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06157
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-06157
  • CDR0000652790 (REGISTRY: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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