Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant

Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With Ascending Doses of JVRS-100 Adjuvant

This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.

The purpose of this trial is to evaluate the safety and tolerability of graded, ascending doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.

Inclusion Criteria:

• able to understand the study and provide written informed consent
• be age 18 to 49 years
• be in good general health, without significant medical history, physical examination findings, or abnormal laboratory results
• be available for the study duration, including all planned follow-up visits
• female subjects of child bearing potential must not be pregnant and agree to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before the study and during the study

Exclusion Criteria:

• have allergy to eggs or other components of the vaccine
• have had an influenza vaccine within 3 years preceding the screening visit
• have a history of severe reaction of any kind to conventional influenza vaccines
• have or suspected immunodeficiency disorder, including leukemia, lymphoma, generalized malignancy, or treatment with immunosuppressive medications, including corticosteroids, alkylating agents, antimetabolites, or radiation therapy
• have a history of an autoimmune disorder, including systemic lupus, rheumatoid arthritis, scleroderma, other collagen vascular disease, multiple sclerosis, etc. Psoriasis limited to cutaneous manifestations is not an exclusion criterion.
• have prior history of anaphylaxis to foods, hymenoptera stings, vaccines or drugs
• have had transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 3 months of the Screening Visit or anticipated through the study period
• have received another vaccine within 30 days preceding the screening visit or anticipated through the study period
• have participation in another clinical trial within 60 days of the screening visit
• have a positive serum or urine pregnancy test prior to vaccination or plan on a pregnancy during study period
• have abnormalities on laboratory assessment
• be seropositive to HIV or HCV or positive for HBsAg
• be positive for anti-nuclear antibodies
• have a physical examination indicating any clinically significant medical condition
• have a body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to vaccination
• intention to travel out of the area prior to the study visit on Day 28 of the study
• have a history of excessive alcohol consumption, drug abuse, significant psychiatric illness
• have the intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 28 of the study