Immune Responses Induced by Different Licensed Influenza Vaccines
Primary Purpose
Immune Response
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flulaval
Fluvirin
Fluzone
Fluarix
Afluria
Sponsored by
About this trial
This is an interventional basic science trial for Immune Response focused on measuring influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines
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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Flulaval
Fluvirin
Fluzone
Fluarix
Affluria
Arm Description
Outcomes
Primary Outcome Measures
T Cell Responses Following Immunization
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00902278
First Posted
May 13, 2009
Last Updated
October 17, 2017
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT00902278
Brief Title
Immune Responses Induced by Different Licensed Influenza Vaccines
Official Title
Immune Response Induced by Different Manufacturers of Influenza Vaccines
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response
Keywords
influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flulaval
Arm Type
Active Comparator
Arm Title
Fluvirin
Arm Type
Active Comparator
Arm Title
Fluzone
Arm Type
Active Comparator
Arm Title
Fluarix
Arm Type
Active Comparator
Arm Title
Affluria
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Flulaval
Intervention Description
one 0.5-mL dose via intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluvirin
Intervention Description
one 0.5-mL dose via intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluzone
Intervention Description
one 0.5-mL dose via intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
one 0.5-mL dose via intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Afluria
Intervention Description
one 0.5-mL dose via intramuscular injection
Primary Outcome Measure Information:
Title
T Cell Responses Following Immunization
Description
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 Outcome Measure Information:
Title
Antibody Responses Following Immunization
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dawn T Co, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
12. IPD Sharing Statement
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Immune Responses Induced by Different Licensed Influenza Vaccines
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