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Immune Responses Induced by Different Licensed Influenza Vaccines

Information source: University of Massachusetts, Worcester
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Response

Intervention: Fluvirin (Biological); Flulaval (Biological); Fluzone (Biological); Fluarix (Biological); Afluria (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: University of Massachusetts, Worcester

Official(s) and/or principal investigator(s):
Mary Dawn T Co, MD, Principal Investigator, Affiliation: University of Massachusetts, Worcester

Overall contact:
Mary Dawn T Co, MD, Phone: 508-856-2927, Email: mary.co@umassmed.edu

Summary

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

Clinical Details

Official title: Immune Response Induced by Different Manufacturers of Influenza Vaccines

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: T cell responses following immunization

Secondary outcome: antibody responses following immunization

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Mary Dawn T Co, MD, Phone: 508-856-2927, Email: mary.co@umassmed.edu

University of Massachusetts Medical School, Worcester, Massachusetts 01605, United States; Recruiting
Mary Dawn T Co, MD, Principal Investigator
Additional Information

Starting date: October 2008
Last updated: September 26, 2011

Page last updated: December 08, 2011

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