A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: AVX502
* Biological: AVX502
* Biological: Placebo
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T1<br> | Biological: AVX502<br>* 2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route<br>|
| Active Comparator: T2<br> | Biological: AVX502<br>* 2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route<br>|
| Placebo Comparator: C1<br> | Biological: Placebo<br>* 2 doses of placebo given at T=0 and T=4 weeks via the IM route<br>|
| Placebo Comparator: C2<br> | Biological: Placebo<br>* 2 doses of placebo given at T=0 and T=4 weeks via the SC route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the immunogenicity of AVX502 in healthy adult volunteers 65 years of age and older via serum antibody concentration |  | 4 weeks after second dose of vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu, Influenza, A/Wyoming/03/2003, Alphavirus