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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluzone vaccine with JVRS-100 adjuvant
* Biological: Fluzone vaccine
* Biological: Fluzone vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant | Biological: Fluzone vaccine with JVRS-100 adjuvant<br>* One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.<br>* Other names: adjuvant;|
| Active Comparator: 2<br>Arm includes treatment with half adult dose of Fluzone® vaccine | Biological: Fluzone vaccine<br>* One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.<br>* Other names: Flu vaccine;|
| Active Comparator: 3<br>Arm includes treatment with full adult dose Fluzone® vaccine | Biological: Fluzone vaccine<br>* One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.<br>* Other names: Flu vaccination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of adverse events between treatment groups |  | Active Study Duration | 
| Dose-response analysis of HAI geometric mean titers (GMT) |  | 5 time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort. |  | 2 periods | 
| Seroprotection and seroconversion rates to various antigens, distribution of antibody titers, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against drifted strains. |  | 5 time points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu, Influenza vaccine, Adjuvant, Safety of an adjuvanted vaccine, Immune response to an adjuvanted vaccine