Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls

The Cleveland Clinic1 site in 1 country36 target enrollmentOctober 2002

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: The Cleveland Clinic
Enrollment: 36
Locations: 1
Primary Endpoint: Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

Detailed Description

Patients who receive bone marrow transplantation are at high risk for complications from influenza infection. It is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called "nonmyeloablative", or "reduced intensity" bone marrow transplantation. This study compares the response to influenza vaccination in a group of these patients to that in healthy people.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

April 2003

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

•Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years.
•Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination.

Exclusion Criteria

•Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy.
•Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

Outcomes

Primary Outcomes

Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?