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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662272
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : March 17, 2010
Information provided by:
Colby Pharmaceutical Company

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone vaccine with JVRS-100 adjuvant Biological: Fluzone vaccine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 1
Arm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant
Biological: Fluzone 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.
Other Names:
  • Fluzone vaccine
  • adjuvant

Active Comparator: 2
Arm includes treatment with half adult dose of Fluzone® vaccine
Biological: Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
Other Name: Flu vaccine

Active Comparator: 3
Arm includes treatment with full adult dose Fluzone® vaccine
Biological: Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
Other Name: Flu vaccination

Primary Outcome Measures :
  1. Comparison of adverse events between treatment groups [ Time Frame: Active Study Duration ]
  2. Dose-response analysis of HAI geometric mean titers (GMT) [ Time Frame: 5 time points ]

Secondary Outcome Measures :
  1. Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort. [ Time Frame: 2 periods ]
  2. 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. [ Time Frame: 5 time points ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662272

United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Colby Pharmaceutical Company
Study Director: Thomas P Monath, MD Medical Monitor for Juvaris

CBER. Guidance for Industry. Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines. May 2007. Available at hhtp://
CBER. Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Guidance. September 2007. Available at hhtp://

Responsible Party: Maggie Sisti, Juvaris BioTherapeutics, Inc. Identifier: NCT00662272     History of Changes
Other Study ID Numbers: H-100-001
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: March 17, 2010
Last Verified: March 2010

Keywords provided by Colby Pharmaceutical Company:
Influenza vaccine
Safety of an adjuvanted vaccine
Immune response to an adjuvanted vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs