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Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura

This study has been completed.
Sponsor:
Collaborator:
Terrana ITP Research Fund
Information provided by:
Neufeld, Ellis J, MD, PhD
ClinicalTrials.gov Identifier:
NCT01713855
First received: October 18, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention
Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenic Purpura
Biological: Inactivated Trivalent Influenza vaccine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)

Resource links provided by NLM:


Further study details as provided by Neufeld, Ellis J, MD, PhD:

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.

Enrollment: 10
Study Start Date: October 2004
Study Completion Date: March 2006
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.
  Eligibility

Ages Eligible for Study:   18 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713855

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Neufeld, Ellis J, MD, PhD
Terrana ITP Research Fund
Investigators
Principal Investigator: Ellis J Neufeld, MD, PhD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Ellis J. Neufeld, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01713855     History of Changes
Other Study ID Numbers: CHB 04-10-143
Study First Received: October 18, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Neufeld, Ellis J, MD, PhD:
ITP
Rituximab
Vaccine
Immune Reconstitution

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014