Immune Responses Induced by Different Licensed Influenza Vaccines

University of Massachusetts, Worcester193 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

193

Conditions

Immune Response

Interventions

FlulavalBIOLOGICAL

one 0.5-mL dose via intramuscular injection

FluvirinBIOLOGICAL

one 0.5-mL dose via intramuscular injection

FluzoneBIOLOGICAL

one 0.5-mL dose via intramuscular injection

Fluarix

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

T Cell Responses Following Immunization

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Secondary Outcomes

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

Time frame: Prevaccination and approximately 1 month post vaccination

Data from ClinicalTrials.gov

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