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

Completed

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

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.

Key facts

Study ID

NCT02006784

Run by

Vanderbilt University

People needed

17

Starts

2013-09-01

Expected to finish

2017-04-01

Last updated by the study team

2017-05-03

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• INCLUSION CRITERIA:
• 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

Where it is running

• Baylor Institute for Immunology Research — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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