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

This study has been completed.
Sponsor:
Information provided by:
Colby Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00662272
First received: April 15, 2008
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Influenza
Biological: Fluzone vaccine with JVRS-100 adjuvant
Biological: Fluzone vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Colby Pharmaceutical Company:

Primary Outcome Measures:
  • Comparison of adverse events between treatment groups [ Time Frame: Active Study Duration ] [ Designated as safety issue: Yes ]
  • Dose-response analysis of HAI geometric mean titers (GMT) [ Time Frame: 5 time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Fluzone vaccine
  • 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 Names:
  • Fluzone vaccine
  • Flu vaccination

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662272

Locations
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
Investigators
Study Director: Thomas P Monath, MD Medical Monitor for Juvaris
  More Information

Publications:
CBER. Guidance for Industry. Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines. May 2007. Available at hhtp://www.fda.gov/cber/guidelines.htm
Centers for Disease Control and Prevention. Prevention and Control of Influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morbidity and Mortality Weekly Report. 2006;55(RR-10):1-42. Erratum: 2006;55(29) 800.
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://www.fda.gov/cber/guidelines.htm

Responsible Party: Maggie Sisti, Juvaris BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00662272     History of Changes
Other Study ID Numbers: H-100-001
Study First Received: April 15, 2008
Last Updated: March 15, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014