Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)

NCT02006784 | Completed

• 1 other identifier: CISA 2013 TASK II
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (2)

• Lupus Flares

  90 days

• To assess immunogenicity of IIV in children with autoimmunity on two different immunosuppressive regimens

  90days

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University Medical Center: collaborator
• Baylor Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Baylor Institute for Immunology Research

Dallas, Texas, 75204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Blood

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)