Immune Responses Induced by Different Licensed Influenza Vaccines

Immune Response Clinical Trial

Official title:

Immune Response Induced by Different Manufacturers of Influenza Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902278
• Other study ID #: H 13000
• 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
• 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

Related Conditions & MeSH terms

• Immune Response
• Influenza, Human

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