Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
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|ClinicalTrials.gov Identifier: NCT01713855|
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : October 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenic Purpura||Biological: Inactivated Trivalent Influenza vaccine||Not Applicable|
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:
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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 :||October 2004|
|Actual Study Completion Date :||March 2006|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713855
|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|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Ellis J Neufeld, MD, PhD||Boston Children's Hospital|