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

Influenza Clinical Trial

— H-100-001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662272
• Other study ID #: H-100-001
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2008
• Last updated: March 15, 2010
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Colby Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
• Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Colby Pharmaceutical Company

Country where clinical trial is conducted

United States, 

References & Publications (13)

Advisory Committee on Immunization Practices, Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and Control of Influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006 Jul 28;55(RR-10):1-42. Erratum in: MMWR Morb Mortal Wkly Rep. 2006 Jul 28;55(29):800. — View Citation

Banzhoff A, Nacci P, Podda A. A new MF59-adjuvanted influenza vaccine enhances the immune response in the elderly with chronic diseases: results from an immunogenicity meta-analysis. Gerontology. 2003 May-Jun;49(3):177-84. — View Citation

Barker WH. Excess pneumonia and influenza associated hospitalization during influenza epidemics in the United States, 1970-78. Am J Public Health. 1986 Jul;76(7):761-5. — View Citation

Betts RF, Treanor JJ. Approaches to improved influenza vaccination. Vaccine. 2000 Feb 25;18(16):1690-5. — View Citation

Beyer WE, Palache AM, Lüchters G, Nauta J, Osterhaus AD. Seroprotection rate, mean fold increase, seroconversion rate: which parameter adequately expresses seroresponse to influenza vaccination? Virus Res. 2004 Jul;103(1-2):125-32. — View Citation

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

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

de Jong JC, Palache AM, Beyer WE, Rimmelzwaan GF, Boon AC, Osterhaus AD. Haemagglutination-inhibiting antibody to influenza virus. Dev Biol (Basel). 2003;115:63-73. Review. — View Citation

Glezen WP. Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev. 1982;4:25-44. Review. — View Citation

Hilleman MR. Realities and enigmas of human viral influenza: pathogenesis, epidemiology and control. Vaccine. 2002 Aug 19;20(25-26):3068-87. Review. — View Citation

Monto AS, Kioumehr F. The Tecumseh Study of Respiratory Illness. IX. Occurence of influenza in the community, 1966--1971. Am J Epidemiol. 1975 Dec;102(6):553-63. — View Citation

Pfleiderer M, Löwer J, Kurth R. Cold-attenuated live influenza vaccines, a risk-benefit assessment. Vaccine. 2001 Dec 12;20(5-6):886-94. Review. — View Citation

Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of adverse events between treatment groups		Active Study Duration	Yes
Primary	Dose-response analysis of HAI geometric mean titers (GMT)		5 time points	No
Secondary	Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort.		2 periods	Yes
Secondary	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	No