Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura

NCT01713855 | Completed

• 1 other identifier: CHB 04-10-143
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Idiopathic Thrombocytopenic Purpura; Immune Thrombocytopenic Purpura

Keywords

ITP; Rituximab; Vaccine; Immune Reconstitution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Interventions

Inactivated Trivalent Influenza vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neufeld, Ellis J, MD, PhD: lead
• Terrana ITP Research Fund: collaborator

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ellis J Neufeld, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2004
• Study Completion: March 1, 2006
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (3)