Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant (H-100-001)

Colby Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Fluzone vaccine; Biological: Fluzone vaccine with JVRS-100 adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662272

H-100-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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128 participants in 3 patient groups

1

Experimental group

Description:

Arm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant

Treatment:

Biological: Fluzone vaccine with JVRS-100 adjuvant

2

Active Comparator group

Description:

Arm includes treatment with half adult dose of Fluzone® vaccine

Treatment:

Biological: Fluzone vaccine

Biological: Fluzone vaccine

3

Active Comparator group

Description:

Arm includes treatment with full adult dose Fluzone® vaccine

Treatment:

Biological: Fluzone vaccine

Biological: Fluzone vaccine