Influenza Clinical Trial
Official title:
Randomized, Double Blind, Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With and Without JVRS-100 Adjuvant in Subjects 65 Years and Older
This study is designed to determine the optimal dose of JVRS-100 and assess safety, tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged ≥65 years.
Status | Completed |
Enrollment | 472 |
Est. completion date | September 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Be adult volunteers aged =65 years - Live in the community, independently or in an assisted living environment - Be Class 1-5, as defined by the CSHA-CFS - If female, will be post-menopausal - Will be available for the duration of the trial (21-day On Study Period) and Follow-Up (4 and 9 months after vaccination) - Be 'probably not demented' on the Mini-Cog test - Provide informed consent - Agree to defer receipt of vaccination of novel H1N1 (swine) influenza until after completion of the Day 28 study procedures Exclusion Criteria: - Known allergy to eggs or other components of the vaccine. - History of severe reaction of any kind to conventional influenza vaccines - Be Class 6-7 in the CSHA-CFS or be institutionalized (e.g., in a nursing home) - Requiring nursing home-level equivalent care at home or within a community assisted living environment - Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. - Significant cardiovascular disease (e.g., NYHA class 3 through 4 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled ventricular cardiac arrhythmias); resting heart rate >100; - A history of chronic obstructive pulmonary disease or history of other lung disease requiring chronic steroid treatment in excess of a bioequivalent dose of 10 mg prednisone daily; a combined history of lung disease and anemia. - Evidence of significant (more than 10 pounds) of unintentional weight loss in the last year. - Changed residence or become hospitalized in the last 6 months. - Combined history of depression and anemia. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Use of any investigational product within 60 days preceding the administration of the study vaccine, or planned use during the study period. - Seropositive to HIV or HCV or positive for HBsAg - Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to vaccination (subject may be rescheduled) - History of excessive alcohol consumption, drug abuse, or significant psychiatric illness. - Be 'probably demented' on the Min-Cog test - Need for guardian assistance in completing informed consent - Has received vaccination for novel H1N1 (swine) influenza |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Colby Pharmaceutical Company |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups. | Active Study Duration | Yes | |
Primary | Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT) | Day 0, 21, 28, Month 4 and 9 | No | |
Secondary | Safety: Comparison of AE rates at intervals between treatment groups. | Active Study Duration | Yes | |
Secondary | Immunogenicity: Comparison of Fluzone® with JVRS-100 by examining seroprotection and seroconversion rates to various antigens, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against drifted strains. | Day 0, 21, 28 and Month 4 and 9 | No | |
Secondary | T-cell responses will be measured. | Day 0, 7, 14 and 28 | No |
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