Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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