Pilot Study in Children with Systemic Lupus Erythematosus (SLE) on Immunosuppressive Medication Regimens to Assess Symptoms/Flares, Measure Traditional and Novel Blood Biomarkers of Inflammation, and Measure Hemagglutination Inhibition Antibody Titers Following Receipt of Inactivated Influenza Vaccine (IIV)

Study ID
STU 052013-074

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Texas Scottish Rite Hospital for Children
  • Children's Medical Center-Dallas

Contact
Michelle Edens
214-641-9789
michelle.edens@baylorhealth.edu

Principal Investigator
Tracey Wright

Summary

Study objectives and endpoints
General objective
The objective of this study is to evaluate the feasibility of conducting a larger, multi-center study to assess: a) safety outcomes, including the risk of flares and other adverse events, following iiV in children/adolescents with SLe b) the immunogenicity of iiV in children/adolescents with SLe.

Specific objectives
1. objective : To assess the achievability of the protocol conduct
endpoints:
* 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 cohort

2. objective: To be able to evaluate an incremental risk of disease flares and other adverse events after iiV
endpoints:
* 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

3. objective: To assess immunogenicity of iiV in children with autoimmunity on two different immunosuppressive regimens
endpoints:
* To ascertain the development of neutralizing and 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.

Treatment arm 1 (for at least 3 months prior to enrollment)
o Prednisone dose [Less Than] 25mg/day at enrollment
o Standard hydroxychloroquine dose

Treatment arm 2 (for at least 3 months prior to enrollment)
o Prednisone dose [Less Than] 20mg/day at enrollment
o Standard hydroxychloroquine dose
o Mycophenolate Mofetil (MMF)

Participant Eligibility

1. Complete immunization history must be available at time of enrollment
2. Patients will be aged 8-18 years at time of enrollment
3. Patient will have stable disease activity (no changes in SLEDAI >2 points) during the 3 months preceding enrollment.
4. 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.