Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713855
• Other study ID #: CHB 04-10-143
• Status: Completed
• Phase: N/A
• First received: October 18, 2012
• Last updated: October 24, 2012
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: October 2012
• Source: Neufeld, Ellis J, MD, PhD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Biological:
• Inactivated Trivalent Influenza vaccine

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Children's Hospital	Boston	Massachusetts
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Neufeld, Ellis J, MD, PhD	Terrana ITP Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of patients with any increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination
Secondary	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
Secondary	The number of patients with any increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination.