Systemic Lupus Erythematosus (SLE)NCT02006784
Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)
An observational study of Systemic Lupus Erythematosus (SLE), run by Vanderbilt University at 1 site in United States.
Trial summary
This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2017
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will recruit and enroll thirty pediatric patients, 8-18 years of age,with a diagnosis of mild to moderate (SLEDAI < 6) Systemic Lupus Erythematosus, who are seen for routine clinic visits in the rheumatology clinics at Texas Scottish Rite Hospital and Children's Medical Center, Dallas, TX during the 2013-2014 influenza seasons. Treatment Arms 1 and 2 will be comprised of patients with similar demographics in terms of race, ethnicity, and gender.
Who may be able to join
- Subjects who meet the following criteria will be allowed to participate in the study:
- Complete immunization history must be available at time of enrollment
- Patients will be aged 8-18 years at time of enrollment
- Patient will have stable disease activity (no changes in SLEDAI >2 points) during the 3 months preceding enrollment.
- Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community.
Who cannot join
- Subjects who meet the following criteria will not be allowed to participate in the study:
- Females who are known to be pregnant or breastfeeding
- Moderate to high SLE disease activity at enrollment (SLEDAI >6)
- Oral temp ≥100F (≥37.8) within 72 hours prior to vaccination
- History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent
- History of Guillain-Barré syndrome after previous immunizations
Show all 14Show fewer
- Unstable SLE disease activity during 3 months prior to enrollment (change in SLEDAI score >2)
- Requirement for high-dose IV Solumedrol and/or Cytoxan pulse therapy during 6 months prior to study
- Any condition that study site investigator deems would put patient at unacceptable risk of injury or render patient unable to meet requirements of the protocol.
- Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged.
- Patient has received other inactivated vaccines within 14 days prior to administration of IIV.
- Patient is scheduled to receive another routinely administered inactivated vaccine within 14 days after IIV.
- Patient is currently participating in a study that involves and experimental agent (vaccine, drug, biologic, device, blood product, or medication), or expects to receive another experimental agent during participation in this study
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Institute for Immunology Research
Dallas, Texas, 75204
About this study
Official title: Pilot Study in Children With Systemic Lupus Erythematosus (SLE) to Assess Flares and to Measure Traditional and Novel Blood Biomarkers and Antibody Titers Following Receipt of Inactivated Influenza Vaccine (IIV)
This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.
Read the detailed description
This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season.
Annual receipt of IIV is recommended for persons with SLE and is considered a standard of care medical practice. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.
Little is known about the immune responses to influenza and other vaccines in children and adolescents with autoimmune conditions, both in terms of immunogenicity as well as the potential for triggering or worsening of immune/autoimmune pathways. Patients with SLE often must take two or more immunosuppressive medications to control their illness. Thus, it is critically important to study vaccine safety and immunogenicity within the pediatric SLE population rather than extrapolate the limited data available from adult clinical studies. Newly diagnosed, untreated patients will be too sick to include in this study. After that, patients are on some immunosuppressive regimen for an extended period of time.
This project will inform the process for a subsequent larger multi-center study to assess IIV safety utilizing an established clinical research network in pediatric rheumatology, such as the Childhood Arthritis and Rheumatology Research Alliance (CARRA) or other venue.
The pilot study will enroll 30 children with mild to moderate SLE as defined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) of <6. A SLEDAI score is an SLE Disease Activity Index which consists of 24 items made up of both clinical data and laboratory results. This score is assessed each time that a patient with SLE is seen in the clinic. It is anticipated that the subjects would be enrolled over 2 to 3 months prior to the influenza season, so as to immunize the SLE patients with IIV before they would be exposed to the circulating wild-type influenza virus. Patients will be followed for 3 months.
Thirty patients receiving one of two different treatment regimens that are standard-of-care regimes, "Prednisone + Hydroxychloroquine" or Prednisone+ Hydroxychloroquine + Mycophenolate Mofetil (MMF), will be observed. All subjects will receive US-licensed influenza vaccines as part of standard medical practice.
These two regimens were chosen because they represent customary care immunosuppressant medication regimens for persons with SLE. In addition, MMF in the second treatment arm has an inhibitory effect on plasma cell development, therefore allowing us to explore whether patients receiving this drug will have diminished antibody responses in response to vaccination.
Fifteen patients will already be receiving Prednisone + Hydroxychloroquine and 15 patients will already be receiving Prednisone+ Hydroxychloroquine + Mycophenolate Mofetil (MMF) as their routine care
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the achievability of the pilot protocol
- Ability to recruit the entire sample cohort of 30 subjects during the pre-planned enrollment period.
- Eighty percent of subjects complete all blood draws within the designated time frame
- Adherence to protocol for blood collection, reaction assessment, clinic follow up, and laboratory analysis for 80% of the enrolled cohor
Measured: 18 months
Secondary outcomes (2)
Lupus Flares
- To ascertain the ability to detect flares and associate the flare to vaccine
- To correlate post-vaccine changes in blood biomarkers with the development of flares as assessed by SLEDAI and BILAG scores as well as self- and physician-assessed reactogenicity
Measured: 90 days
To assess immunogenicity of IIV in children with autoimmunity on two different immunosuppressive regimens
- To ascertain the development of neutralizing and hemagglutination inhibition (HAI) antibody titers at baseline and at 28 days (+ 7 day)
- To correlate changes in blood biomarkers with response to vaccine using immune profiling analysis.
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Baylor Research Institute, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Kathryn Edwards, Vanderbilt University
- Investigators
- M. Virginia Pascual, MD, Principal investigator, Baylor Research InstituteKathryn M Edwards, MD, Principal investigator, Vanderbilt Medical CenterTheresa Harrington, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006784
- Sponsor's protocol ID
- CISA 2013 TASK II
- Status last verified
- May 2017
- First submitted
- 4 Dec 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study in Children With Systemic Lupus Erythematosus (SLE) to Assess Flares and to Measure Traditional and Novel Blood Biomarkers and Antibody Titers Following Receipt of Inactivated Influenza Vaccine (IIV)
- ClinicalTrials.gov ID
- NCT02006784
- Acronym / sponsor ID
- CISA 2013 TASK II
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Baylor Research Institute, Centers for Disease Control and Prevention
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Dec 2013 (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.
This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.
Detailed description
This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season.
Annual receipt of IIV is recommended for persons with SLE and is considered a standard of care medical practice. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.
Little is known about the immune responses to influenza and other vaccines in children and adolescents with autoimmune conditions, both in terms of immunogenicity as well as the potential for triggering or worsening of immune/autoimmune pathways. Patients with SLE often must take two or more immunosuppressive medications to control their illness. Thus, it is critically important to study vaccine safety and immunogenicity within the pediatric SLE population rather than extrapolate the limited data available from adult clinical studies. Newly diagnosed, untreated patients will be too sick to include in this study. After that, patients are on some immunosuppressive regimen for an extended period of time.
This project will inform the process for a subsequent larger multi-center study to assess IIV safety utilizing an established clinical research network in pediatric rheumatology, such as the Childhood Arthritis and Rheumatology Research Alliance (CARRA) or other venue.
The pilot study will enroll 30 children with mild to moderate SLE as defined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) of <6. A SLEDAI score is an SLE Disease Activity Index which consists of 24 items made up of both clinical data and laboratory results. This score is assessed each time that a patient with SLE is seen in the clinic. It is anticipated that the subjects would be enrolled over 2 to 3 months prior to the influenza season, so as to immunize the SLE patients with IIV before they would be exposed to the circulating wild-type influenza virus. Patients will be followed for 3 months.
Thirty patients receiving one of two different treatment regimens that are standard-of-care regimes, "Prednisone + Hydroxychloroquine" or Prednisone+ Hydroxychloroquine + Mycophenolate Mofetil (MMF), will be observed. All subjects will receive US-licensed influenza vaccines as part of standard medical practice.
These two regimens were chosen because they represent customary care immunosuppressant medication regimens for persons with SLE. In addition, MMF in the second treatment arm has an inhibitory effect on plasma cell development, therefore allowing us to explore whether patients receiving this drug will have diminished antibody responses in response to vaccination.
Fifteen patients will already be receiving Prednisone + Hydroxychloroquine and 15 patients will already be receiving Prednisone+ Hydroxychloroquine + Mycophenolate Mofetil (MMF) as their routine care
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will recruit and enroll thirty pediatric patients, 8-18 years of age,with a diagnosis of mild to moderate (SLEDAI < 6) Systemic Lupus Erythematosus, who are seen for routine clinic visits in the rheumatology clinics at Texas Scottish Rite Hospital and Children's Medical Center, Dallas, TX during the 2013-2014 influenza seasons. Treatment Arms 1 and 2 will be comprised of patients with similar demographics in terms of race, ethnicity, and gender.
Key inclusion criteria (5 listed)
- Complete immunization history must be available at time of enrollment
- Patients will be aged 8-18 years at time of enrollment
- Patient will have stable disease activity (no changes in SLEDAI >2 points) during the 3 months preceding enrollment.
- Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community.
Key exclusion criteria (14 listed)
- Females who are known to be pregnant or breastfeeding
- Moderate to high SLE disease activity at enrollment (SLEDAI >6)
- Oral temp ≥100F (≥37.8) within 72 hours prior to vaccination
- History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent
- History of Guillain-Barré syndrome after previous immunizations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the achievability of the pilot protocol
Time frame: 18 months
* Ability to recruit the entire sample cohort of 30 subjects during the pre-planned enrollment period. * Eighty percent of subjects complete all blood draws within the designated time frame * Adherence to protocol for blood collection, reaction assessment, clinic follow up, and laboratory analysis for 80% of the enrolled cohor
2 secondary outcomes
Lupus Flares
Time frame: 90 days
To assess immunogenicity of IIV in children with autoimmunity on two different immunosuppressive regimens
Time frame: 90days
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 3 May 2017.
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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.
M. Virginia Pascual, MD principal investigator
Baylor Research Institute
Kathryn M Edwards, MD principal investigator
Vanderbilt Medical Center
Theresa Harrington, MD principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by Vanderbilt University at 1 site 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 5 inclusion and 14 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To assess the achievability of the pilot protocol (time frame: 18 months). 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 3 May 2017.