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OpenTrials
Completed

NCT Number: NCT00902278

Immune Responses Induced by Different Licensed Influenza Vaccines

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flulaval

Biological

one 0.5-mL dose via intramuscular injection

Fluvirin

Biological

one 0.5-mL dose via intramuscular injection

Fluzone

Biological

one 0.5-mL dose via intramuscular injection

Fluarix

Biological

one 0.5-mL dose via intramuscular injection

Afluria

Biological

one 0.5-mL dose via intramuscular injection

Primary outcomes

  1. T Cell Responses Following Immunization

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

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

Secondary outcomes

  1. Antibody Responses Following Immunization

    Time frame: Prevaccination and approximately 1 month post vaccination

    Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Immune Response Induced by Different Manufacturers of Influenza Vaccines

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
May 15, 2009
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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