Flu Vaccine Study in Neuromuscular Patients 2011
Condition: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Congenital Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the immune response of two different injection methods
      (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among
      patients with neuromuscular conditions who have significant muscle degeneration. This
      research study hypothesizes that the subcutaneous route of vaccine administration, as
      compared to the intramuscular route, may confer at least comparable, or possibly better,
      immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive
      Care Center will be recruited to participate in this study lasting approximately one to two
      months with two clinic visits and one follow-up telephone call. Immunogenicity will be
      assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and
      post-vaccination.
    

Detailed description: 
      Individuals with neuromuscular diseases are more prone to influenza-related morbidity.
      Vaccination is the most effective measure to reduce the influenza disease burden. In the
      United States, the recommended route of administration for the inactivated influenza vaccine
      is intramuscular. In other countries, the subcutaneous, deep subcutaneous, and intramuscular
      routes are all considered acceptable for influenza vaccine administration. The United States
      CDC states that subcutaneous influenza vaccine doses, provided they are age-appropriate, may
      be counted as valid.

      Those with neuromuscular diseases have muscle fibrosis that may potentially make
      intramuscular vaccines more effective. Those with Duchenne muscular dystrophy receive
      systemic corticosteroids to reduce inflammation. Corticosteroids may suppress antibody
      responses to vaccines. The goal of this research study is to evaluate the immunogenicity and
      safety of intramuscular and subcutaneous administration of inactivated influenza vaccine in
      individuals with neuromuscular diseases. This is a single site, open-label, randomized study.
      At the first visit, a blood sample was collected prior to vaccination. Each subject received
      either an intramuscular or subcutaneous vaccine administered in the anterolateral aspect of
      the thigh. Within 30 minutes of vaccination, subjects rated pain at the injection site using
      a numeric pain scale (0-10). Subjects and their caregivers were also asked to record local
      and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. Subjects
      were instructed to notify the study staff by telephone should they develop any serious
      adverse reactions following vaccination. At a second study visit approximately 28 days later,
      a repeat blood sample was obtained. The blood samples obtained pre-vaccination and also at
      day 28 were tested for hemagglutination inhibition (HI) titers to the three influenza vaccine
      strains. rovider's office. The geometric mean titer ratios for each of the three vaccine
      strains were calculated as the ratios of postvaccination to prevaccination titers at
      geometric mean scale.
    

Intervention name(s): 2011-2012 seasonal flu vaccine Subcutaneous; 2011-2012 seasonal flu vaccine Intramuscular
Intervention type(s): Biological; Biological
Other intervention name(s): fluzone; fluzone
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: DMD; SMA; CMD; flu vaccine