Idiopathic Thrombocytopenic PurpuraNCT01713855
Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
A study testing Inactivated Trivalent Influenza vaccine in people with Idiopathic Thrombocytopenic Purpura and Immune Thrombocytopenic Purpura, run by Neufeld, Ellis J, MD, PhD at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura
- What is being tested?
- Inactivated Trivalent Influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2004to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously or currently enrolled in parent study, see CHB 02-12-160
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Children's Hospital
Boston, Massachusetts, 02115
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Being tested
- Inactivated Trivalent Influenza vaccine
- Keywords
- ITP, Rituximab, Vaccine, Immune Reconstitution
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Trivalent Influenza vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neufeld, Ellis J, MD, PhD
- Collaborators
- Terrana ITP Research Fund
- Investigators
- Ellis J Neufeld, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713855
- Sponsor's protocol ID
- CHB 04-10-143
- Status last verified
- Oct 2012
- First submitted
- 18 Oct 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT01713855
- Acronym / sponsor ID
- CHB 04-10-143
- Keywords
- ITP, Rituximab, Vaccine, Immune Reconstitution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neufeld, Ellis J, MD, PhD
- Collaborators
- Terrana ITP Research Fund
- Study start
- Oct 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Previously or currently enrolled in parent study, see CHB 02-12-160
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated Trivalent Influenza vaccine | Biological | – |
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellis J Neufeld, MD, PhD principal investigator
Boston Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivated Trivalent Influenza vaccine in people with Idiopathic Thrombocytopenic Purpura and Immune Thrombocytopenic Purpura, run by Neufeld, Ellis J, MD, PhD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.