Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)
|ClinicalTrials.gov Identifier: NCT02006784|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : May 3, 2017
|Condition or disease|
|Systemic Lupus Erythematosus (SLE)|
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 Type :||Observational|
|Actual Enrollment :||17 participants|
|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)|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2017|
- 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
- Lupus Flares [ Time Frame: 90 days ]
- 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
- To assess immunogenicity of IIV in children with autoimmunity on two different immunosuppressive regimens [ Time Frame: 90days ]
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006784
|United States, Texas|
|Baylor Institute for Immunology Research|
|Dallas, Texas, United States, 75204|
|Principal Investigator:||M. Virginia Pascual, MD||Baylor Research Institute|
|Principal Investigator:||Kathryn M Edwards, MD||Vanderbilt Medical Center|
|Principal Investigator:||Theresa Harrington, MD||Centers for Disease Control and Prevention|