Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant
NCT ID: NCT00662272
Last Updated: 2010-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2008-06-30
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Immunogenicity of Fluzone® With and Without JVRS-100 in Elderly Subjects
NCT00936468
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
NCT01430819
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
NCT00835926
Trial to Describe the Safety and Immunogenicity of Fluzone®
NCT00524940
Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008
NCT01333462
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Arm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant
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.
2
Arm includes treatment with half adult dose of Fluzone® vaccine
Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
3
Arm includes treatment with full adult dose Fluzone® vaccine
Fluzone vaccine
One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Colby Pharmaceutical Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juvaris BioTherapeutics, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas P Monath, MD
Role: STUDY_DIRECTOR
Medical Monitor for Juvaris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Miami Research Associates
Miami, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
Amai M, Nojima M, Yuki Y, Kiyono H, Nagamura F. A review of criteria strictness in "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". Vaccine. 2023 Aug 31;41(38):5622-5629. doi: 10.1016/j.vaccine.2023.07.072. Epub 2023 Aug 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-100-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.