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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00902278
Other study ID # H 13000
Secondary ID
Status Completed
Phase N/A
First received May 13, 2009
Last updated October 17, 2017
Start date October 2008
Est. completion date April 2016

Study information

Verified date June 2017
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 193
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Flulaval
one 0.5-mL dose via intramuscular injection
Fluvirin
one 0.5-mL dose via intramuscular injection
Fluzone
one 0.5-mL dose via intramuscular injection
Fluarix
one 0.5-mL dose via intramuscular injection
Afluria
one 0.5-mL dose via intramuscular injection

Locations

Country Name City State
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary T Cell Responses Following Immunization Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Secondary 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 Prevaccination and approximately 1 month post vaccination
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