Influenza
Conditions
Keywords
Flu, Influenza vaccine, Adjuvant, Safety of an adjuvanted vaccine, Immune response to an adjuvanted vaccine
Brief summary
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
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.
Interventions
BIOLOGICALFluzone vaccine with JVRS-100 adjuvant
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.
BIOLOGICALFluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
Sponsors
Colby Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed