- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706732
A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza (AVX502-003)
July 11, 2012 updated by: AlphaVax, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: T1
|
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
|
Placebo Comparator: C1
|
2 doses of placebo given at T=0 and T=4 weeks via the IM route
2 doses of placebo given at T=0 and T=4 weeks via the SC route
|
Active Comparator: T2
|
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
|
Placebo Comparator: C2
|
2 doses of placebo given at T=0 and T=4 weeks via the IM route
2 doses of placebo given at T=0 and T=4 weeks via the SC route
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks after second dose of vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Olmsted, Ph.D., AlphaVax, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 26, 2008
First Submitted That Met QC Criteria
June 26, 2008
First Posted (Estimate)
June 30, 2008
Study Record Updates
Last Update Posted (Estimate)
July 12, 2012
Last Update Submitted That Met QC Criteria
July 11, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVX502-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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