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A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza (AVX502-003)
This study is ongoing, but not recruiting participants.
Sponsored by: AlphaVax, Inc.
Information provided by: AlphaVax, Inc.
ClinicalTrials.gov Identifier: NCT00706732
  Purpose

The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.


Condition Intervention Phase
Influenza
Biological: AVX502
Biological: Placebo
Phase I
Phase II

MedlinePlus related topics: Flu
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title: A Single-Site, Phase I/II, Double Blinded, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Adult Volunteers 65 Years of Age or Older

Further study details as provided by AlphaVax, Inc.:

Primary Outcome Measures:
  • Evaluate the safety of AVX502 in healthy adult volunteers 65 years of age or older via the frequency of systemic reactogenicity events, local vaccine reactions and Adverse Events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration [ Time Frame: 4 weeks after second dose of vaccine ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: June 2008
Estimated Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
T1: Active Comparator Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
T2: Active Comparator Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
C1: Placebo Comparator Biological: Placebo
2 doses of placebo given at T=0 and T=4 weeks via the IM route
C2: Placebo Comparator Biological: Placebo
2 doses of placebo given at T=0 and T=4 weeks via the SC route

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 65 years of age or older
  • Good general health without significant physical examination findings or clinically significant abnormal laboratory results
  • Available to participate for entire study period
  • Acceptable laboratory parameters
  • Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
  • Willingness to refrain from donating blood while participating in the study
  • Willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8)
  • Signed inform consent obtained before screening and before enrollment

Exclusion Criteria:

  • Venous access deemed inadequate for th phlebotomy demands of the study
  • Receipt of any other vaccine within 30 days prior to enrollment
  • Use of any investigational agent within 30 days prior to enrollment
  • Receipt of immunoglobulin or other blood products within 60 days prior to enrollment
  • Use of cytotoxic medications within 6 months prior to enrollment
  • Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment)
  • History of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain
  • History of autoimmune disease or splenectomy
  • History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment)
  • Psychiatric condition that may interfere with the ability to comply with the protocol requirements or to understand informed consent. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
  • History of medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
  • Any condition which leads the investigator to believe that the particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706732

Locations
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AlphaVax, Inc.
Investigators
Principal Investigator: Robert Olmsted, Ph.D. AlphaVax, Inc.
  More Information

AlphaVax, Inc.  This link exits the ClinicalTrials.gov site
Johnson County Clin-Trials  This link exits the ClinicalTrials.gov site

Responsible Party: Alphavax ( Robert Olmsted, Ph.D. )
Study ID Numbers: AVX502-003
Study First Received: June 26, 2008
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00706732  
Health Authority: United States: Food and Drug Administration

Keywords provided by AlphaVax, Inc.:
Influenza
Flu
A/Wyoming/03/2003
Alphavirus

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009