Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

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. 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
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Biospecimen description: 
      Serum Blood