Immune Responses Induced by Different Licensed Influenza Vaccines

University of Massachusetts, Worcester

Status: Completed

Conditions: Immune Response

Treatments: Biological: Fluzone; Biological: Flulaval; Biological: Fluarix; Biological: Afluria; Biological: Fluvirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00902278

H 13000

Details and patient eligibility

About

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

Full description

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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 5 patient groups

Flulaval

Active Comparator group

Treatment:

Biological: Flulaval

Fluvirin

Active Comparator group

Treatment:

Biological: Fluvirin

Fluzone

Active Comparator group

Treatment:

Biological: Fluzone

Fluarix

Active Comparator group

Treatment:

Biological: Fluarix

Affluria

Active Comparator group

Treatment:

Biological: Afluria