Flu Vaccine Study in Neuromuscular Patients 2011
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titer Ratio for Each Vaccine Strain [immediately before vaccination and 21-28 days after vaccination]
Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt
Other Outcome Measures
- Safety: Summary of Local and Systemic Reactogenicity Symptoms [4 days following receipt of study vaccine]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
- Principal Investigator: Brenda Wong, MD, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-2319
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Subcutaneous | Intramuscular |
|---|---|---|
| Arm/Group Description | 2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine | 2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine |
| Period Title: Overall Study | ||
| STARTED | 11 | 11 |
| COMPLETED | 11 | 11 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Subcutaneous | Intramuscular | Total |
|---|---|---|---|
| Arm/Group Description | 2011-2012 Northern Hemisphere formulation inactivated influenza vaccine | 2011-2012 Northern Hemisphere formulation inactivated influenza vaccine | Total of all reporting groups |
| Overall Participants | 11 | 11 | 22 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
18.20
(4.88)
|
19.37
(4.23)
|
18.78
(4.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
9.1%
|
1
9.1%
|
2
9.1%
|
| Male |
10
90.9%
|
10
90.9%
|
20
90.9%
|
Outcome Measures
| Title | Geometric Mean Titer Ratio for Each Vaccine Strain |
|---|---|
| Description | Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt |
| Time Frame | immediately before vaccination and 21-28 days after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subcutaneous | Intramuscular |
|---|---|---|
| Arm/Group Description | Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine by subcutaneous route | Subjects receiving 2011-2012 Northern Hemisphere trivalent inactivated influenza vaccine |
| Measure Participants | 11 | 11 |
| HINI vaccine strain |
3.76
|
3.53
|
| H3N2 vaccine strain |
2
|
1.46
|
| B vaccine strain |
1.76
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Subcutaneous, Intramuscular |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Safety: Summary of Local and Systemic Reactogenicity Symptoms |
|---|---|
| Description | 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. |
| Time Frame | 4 days following receipt of study vaccine |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who completed the diary sheets |
| Arm/Group Title | Subcutaneous | Intramuscular |
|---|---|---|
| Arm/Group Description | 0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once 2011-2012 seasonal flu vaccine: Subcutaneous flu vaccine | 0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via intramuscular route once 2011-2012 seasonal flu vaccine: Intramuscular flu vaccine |
| Measure Participants | 8 | 10 |
| Pain |
4
36.4%
|
5
45.5%
|
| Redness |
1
9.1%
|
1
9.1%
|
| Swelling |
2
18.2%
|
1
9.1%
|
| Body ache |
0
0%
|
1
9.1%
|
| Weakness |
0
0%
|
1
9.1%
|
| Irritabiltity |
0
0%
|
1
9.1%
|
| Headache |
1
9.1%
|
0
0%
|
| Cough |
0
0%
|
1
9.1%
|
Adverse Events
| Time Frame | Local and systemic adverse events were collected on diary sheets from day 0 to day 4 after vaccination. Serious adverse events were collected through the final study visit, about 28 days. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Within 30 minutes of vaccination, subjects rated the painfulness using a picture or numeric pain scale. 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. A mild symptom is one which is easily tolerated, a moderate symptom causes interference with usual daily activities, and a severe symptom results in the inability to perform daily activities. | |||
| Arm/Group Title | Intramuscular | Subcutaneous | ||
| Arm/Group Description | 2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once intramuscularly | 2011-2012 Northern Hemisphere formulation trivalent inactivated influenza vaccine administered once via subcutaneous route | ||
All Cause Mortality |
||||
| Intramuscular | Subcutaneous | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/11 (0%) | ||
Serious Adverse Events |
||||
| Intramuscular | Subcutaneous | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/11 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intramuscular | Subcutaneous | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | 8/11 (72.7%) | ||
| General disorders | ||||
| Body Ache | 1/11 (9.1%) | 0/11 (0%) | ||
| Weakness | 1/11 (9.1%) | 0/11 (0%) | ||
| Nervous system disorders | ||||
| Headache | 0/11 (0%) | 1/11 (9.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/11 (9.1%) | 0/11 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Paine/tenderness | 5/11 (45.5%) | 4/11 (36.4%) | ||
| Redness | 1/11 (9.1%) | 1/11 (9.1%) | ||
| Swelling | 1/11 (9.1%) | 2/11 (18.2%) | ||
| Irritability | 1/11 (9.1%) | 0/11 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Brenda Wong |
|---|---|
| Organization | Cincinnati Children's Hospital Medical Center |
| Phone | 5136364222 |
| brenda.wong@cchmc.org |
- 2010-2319