A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza (AVX502-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AlphaVax, Inc.
ClinicalTrials.gov Identifier:
NCT00706732
First received: June 26, 2008
Last updated: July 11, 2012
Last verified: July 2012
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 ]

Enrollment: 28
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: T1 Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
Active Comparator: T2 Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
Placebo Comparator: C1 Biological: Placebo
2 doses of placebo given at T=0 and T=4 weeks via the IM route
Placebo Comparator: C2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: AlphaVax, Inc.
ClinicalTrials.gov Identifier: NCT00706732     History of Changes
Other Study ID Numbers: AVX502-003
Study First Received: June 26, 2008
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014