Immune Responses Induced by Different Licensed Influenza Vaccines



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/22/2017
Start Date:October 2008
End Date:April 2016

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Immune Response Induced by Different Manufacturers of Influenza Vaccines

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

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.

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
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
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