Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura

Sponsor

Neufeld, Ellis J, MD, PhD (Other)

Overall Status

Completed

CT.gov ID

NCT01713855

Collaborator

Terrana ITP Research Fund (Other)

Enrollment

Locations

Duration (Months)

3.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenic Purpura	Biological: Inactivated Trivalent Influenza vaccine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)

Study Start Date :

Oct 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination []

Secondary Outcome Measures

The number of patients with any increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination []
The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination []
The number of patients with any increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Emory University School of Medicine	Atlanta	Georgia	United States	30322
3	Children's Hospital	Boston	Massachusetts	United States	02115