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

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.

Timeline

Start

2008-06

Primary completion

2008-10

Completion

2009-12

Publications

• Background Betts RF, Treanor JJ. Approaches to improved influenza vaccination. Vaccine. 2000 Feb 25;18(16):1690-5. doi: 10.1016/s0264-410x(99)00508-3.
• Background 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. doi: 10.1001/jama.289.2.179.
• Background 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. doi: 10.1093/oxfordjournals.aje.a112193.
• Background 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. doi: 10.2105/ajph.76.7.761.
• Background Glezen WP. Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev. 1982;4:25-44. doi: 10.1093/oxfordjournals.epirev.a036250. No abstract available.
• Background Pfleiderer M, Lower J, Kurth R. Cold-attenuated live influenza vaccines, a risk-benefit assessment. Vaccine. 2001 Dec 12;20(5-6):886-94. doi: 10.1016/s0264-410x(01)00386-3.
• Background Hilleman MR. Realities and enigmas of human viral influenza: pathogenesis, epidemiology and control. Vaccine. 2002 Aug 19;20(25-26):3068-87. doi: 10.1016/s0264-410x(02)00254-2.
• Background 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
• Background 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.
• Background 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.
• Background Beyer WE, Palache AM, Luchters 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. doi: 10.1016/j.virusres.2004.02.024.
• Background 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. doi: 10.1159/000069172.
• Background 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

Drugs

Indications