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Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura

NCT ID: NCT01713855

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to determine how children with a history of severe, chronic Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to vaccines. Eligible patients are previously or currently enrolled in a study entitled "Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura in Children and Adolescents" and have decided to obtain an inactivated influenza vaccination. These patients will be invited to provide one blood sample prior to vaccination and a second sample following vaccination to quantify immune response to vaccination.

Detailed Description

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The purpose of this ancillary, pilot-phase study is to determine how children with a history of severe, chronic ITP who were treated with rituximab might respond to vaccines. Eligible patients are previously or currently enrolled in a study entitled "Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura in Children and Adolescents" (CHB 02-12-160) and have decided to obtain the trivalent, inactivated influenza vaccination. These patients will be invited to provide one blood sample prior to vaccination and a second sample 4-8 weeks after vaccination to quantify immune response to vaccination. Additionally, if patients are scheduled to receive a tetanus booster vaccination within one month before or after the influenza vaccination, response to tetanus will also be quantified. This sample will be collected during the same phlebotomy as the influenza sample. In some cases, a blood sample was stored prior to rituximab treatment and will be used for baseline assessment. The primary and secondary objectives for this study are as follows:

Primary:

* To determine the portion of patients who will respond adequately to influenza vaccination, with adequacy defined as a titer greater than 1:32 for each strain of virus in the vaccine, measured 4-8 weeks after administration of the vaccine OR greater than a four-fold increase in titers measured 4-8 weeks after administration of the vaccine

Secondary Objectives:

* To evaluate the ability to mount a response to the influenza vaccine, with response defined as any increase in influenza antibody titer for each strain of virus between samples before and 4-8 weeks after vaccination.
* To evaluate the ability to mount an adequate response to tetanus toxoid, with adequacy defined as in the primary objective.
* To evaluate the ability to mount a response to tetanus toxoid, with response defined as above.
* To compare response to influenza vaccination received less than one year after rituximab and greater than one year after rituximab.

Conditions

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Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenic Purpura

Keywords

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ITP Rituximab Vaccine Immune Reconstitution

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Inactivated Trivalent Influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previously or currently enrolled in parent study, see CHB 02-12-160

Exclusion Criteria

* Baseline immunodeficiency (i.e. DiGeorge syndrome, Common Variable Immunodeficiency)
* Contraindications for influenza vaccine, including: hypersensitivity to egg products; history of Guillain-Barre syndrome; history of adverse reaction to flu vaccine
* Contraindications for tetanus toxoid, including: hypersensitivity to prior tetanus vaccination; concurrent moderate to severe illness
* Subjects meeting any of the following criteria will be temporarily excluded from the study: high-dose corticosteroid therapy (5-30 mg/kg/day) during the 24 hours immediately prior to the vaccine; IVIG (intravenous immunoglobulin) within 4 months prior to vaccine; platelet count of less than 20,000/ml within one month of vaccination with evidence of grade II or higher skin bleeding, assessed at vaccine administration
Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terrana ITP Research Fund

OTHER

Sponsor Role collaborator

Neufeld, Ellis J, MD, PhD

INDIV

Sponsor Role lead

Responsible Party

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Children's Hospital Boston

Principal Investigators

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Ellis J Neufeld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CHB 04-10-143

Identifier Type: -

Identifier Source: org_study_id