Assessing Antibody Responsiveness to Hepatitis B Vaccine in Aged Lymphoma Patients Undergoing Treatment With Rituximab

March 16, 2009 updated by: Rambam Health Care Campus

Background:

The ability of the immune system to function declines with aging. This is reflected by a marked decrease in the responsiveness to vaccinations and to infectious agents. Consequentially, there is a profound reduction in the quality of live and an increased dependency on the health systems. Studies have shown that the production of B lymphocytes in the bone marrow declines with aging and long-lived B cells accumulate in the periphery. Thus, instead of a juvenile repertoire of B cells that is capable to recognize any new pathogen, the repertoire of the elderly becomes more restricted and fails to respond to new antigens.

Working hypothesis and aims: We hypothesize that the dramatic change in the cellular composition in aging reflects homeostasis pressures that are set by long-lived peripheral B cells. Here, the investigators hypothesize that altering the homeostasis, by active depletion of the peripheral B cells, will revive B lymphopoiesis in the BM and rejuvenate the peripheral repertoire of B cells in aging. Consequentially, this will significantly improve immune responsiveness of aged individuals to new antigenic challenges.

Methods:

The investigators propose a parallel study in human and mouse. For our clinical study we will use old lymphoma patients that were treated with the B cell depleting therapy, RITUXIMAB, for transient B cell depletion and established full B cell reconstitution. We will test the responsiveness of these patients to hepatitis B vaccine and compare it to aged-matched control group. The investigators will also use old human CD20 transgenic mice where B cell depletion is imposed by anti human CD20 antibodies. In these experiments we will study physiological and immunological changes to understand aging mechanisms in the B lineage.

Expected results: We expect that old patients treated for B cell depletion will have an increased responsiveness to the hepatitis B vaccine relative to the control group.

Importance:

The investigators propose an efficient approach to improve immune response in the elderly population. This will increase efficacy of vaccination, reduce morbidity and improve quality of life. It will also reduce the cost of medical treatment. In addition, this study will show that senescence in the B lineage can be reversed, which is in contrast to the general concepts of aging.

Probable implications to the welfare and health of the aged population Medicine:

Improving the immune competence will increase efficacy of vaccination, reduce morbidity, and reduce dependency on health systems. This will significantly improve the quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 55 years and older
  • lymphoma
  • rituximab

Exclusion Criteria:

  • disease remission

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

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rituximab
b cell depletion drug
Biological: rituximab
b cell depletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anti hepatitis B antibodies
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
B cell proliferation and antibody secretion in response to stimulation in vitro
Time Frame: 3 month
3 month

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Collaborators

Technion, Israel Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2010

Study Registration Dates

First Submitted

February 15, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (ESTIMATE)

March 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2009

Last Update Submitted That Met QC Criteria

March 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3097

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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