Flu Vaccine Study in Neuromuscular Patients 2011

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422200
• Other study ID #: 2010-2319
• Status: Completed
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Muscular Dystrophy
• Duchenne Muscular Dystrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Spinal Muscular Atrophy

Intervention

Biological:
• 2011-2012 seasonal flu vaccine Subcutaneous

• 2011-2012 seasonal flu vaccine Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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