Immune Responses Induced by Different Licensed Influenza Vaccines

Study Overview
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Brief Summary
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The goal of this research is to find out how the body's immune system responds to different manufacturer's flu vaccines.

Detailed Description
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There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.

Official Title
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Immune Response Induced by Different Manufacturers of Influenza Vaccines

Conditions
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Immune Response

Intervention / Treatment
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* Biological: Flulaval
* Biological: Fluvirin
* Biological: Fluzone
* Biological: Fluarix
* Biological: Afluria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-50 years of age) Willing to donate a blood sample multiple times Willing to sign informed consent and HIPAA Exclusion Criteria: Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin Previous life threatening reaction to influenza vaccine Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) Occurrence of neurological syndrome within six weeks of previous influenza immunization Active neurological disorder characterized by changing neurological disorder Pregnancy Acute febrile illness History of anemia or bleeding disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flulaval<br> | Biological: Flulaval<br>* one 0.5-mL dose via intramuscular injection<br>|
| Active Comparator: Fluvirin<br> | Biological: Fluvirin<br>* one 0.5-mL dose via intramuscular injection<br>|
| Active Comparator: Fluzone<br> | Biological: Fluzone<br>* one 0.5-mL dose via intramuscular injection<br>|
| Active Comparator: Fluarix<br> | Biological: Fluarix<br>* one 0.5-mL dose via intramuscular injection<br>|
| Active Comparator: Affluria<br> | Biological: Afluria<br>* one 0.5-mL dose via intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T Cell Responses Following Immunization | Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups | Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Responses Following Immunization | Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group | Prevaccination and approximately 1 month post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines