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Influenza Vaccination in Bone Marrow Transplantation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00419224
Enrollment
36
Registered
2007-01-08
Start date
2002-10-31
Completion date
2003-04-30
Last updated
2007-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Peripheral blood stem cell transplantation, Non-myeloabalative, Influenza vaccination, Humoral immune response, Immunogenicity

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.

Interventions

BIOLOGICALinactivated split-virus influenza vaccine

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026