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

AlphaVax

Status and phase

Completed

Phase 2

Phase 1

Conditions

Influenza

Treatments

Biological: Placebo

Biological: AVX502

Study type

Interventional

Funder types

Industry

Identifiers

NCT00706732

AVX502-003

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.