Flu Vaccine Study in Neuromuscular Patients 2011

Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases

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.

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Congenital Muscular Dystrophy
• Intervention / Treatment: Biological: 2011-2012 seasonal flu vaccine Subcutaneous; Biological: 2011-2012 seasonal flu vaccine Intramuscular

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-ambulatory;
• Quadriceps muscle strength of MRC (Medical Research Council Scale) grade 3 or below
• Any subject who is between 3 to 8 years of age must have received at least two doses of influenza vaccine last season or at least one dose tow or more years ago.

Exclusion Criteria:

• Subject must not have a history of severe reactions following previous immunization with influenza vaccine.
• Subject must not have previously received a 2011-2012 influenza vaccine.
• Subject must not have a history of Guillain-Barre syndrome.
• Subject must not have received a live viral vaccine (i.e., MMR, varicella) within 28 days prior to receipt of the study vaccine.
• Subject must not have any condition that the investigator believes would render vaccination unsafe or interfere with successful completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subcutaneous; 0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once	Biological: 2011-2012 seasonal flu vaccine Subcutaneous; Other Names: fluzone
ACTIVE_COMPARATOR: Intramuscular; 0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via intramuscular route once	Biological: 2011-2012 seasonal flu vaccine Intramuscular; Other Names: fluzone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer Ratio for Each Vaccine Strain	Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt	immediately before vaccination and 21-28 days after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Summary of Local and Systemic Reactogenicity Symptoms	For the 4 days following receipt of study vaccine (days 0 to 4), the following local reactions will be assessed: pain, redness, and swelling. The following systemic reactions will also be assessed: body ache, weakness, irritability, headache, and cough.	4 days following receipt of study vaccine

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Brenda Wong, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: August 22, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (ESTIMATE): August 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: DMD; CMD; SMA; flu vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Muscular Disorders, Atrophic; Atrophy; Motor Neuron Disease; Muscular Dystrophies; Muscular Atrophy; Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2010-2319