Clinical trial NCT00902278: Immune Responses Induced by Different Licensed Influenza Vaccines
Official title: Immune Response Induced by Different Manufacturers of Influenza Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: influenzavirus A
influenzavirus B
human influenza
T lymphocytes
influenza vaccines
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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 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

Primary outcomes:
measure: T Cell Responses Following Immunization
timeFrame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Secondary outcomes:
measure: Antibody Responses Following Immunization
timeFrame: Prevaccination and approximately 1 month post vaccination
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Mary Dawn T Co, MD
role: PRINCIPAL_INVESTIGATOR
References: