Safety, Tolerability and Immunogenicity of Fluzone® With and Without JVRS-100 in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Colby Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00936468
First received: July 9, 2009
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Colby Pharmaceutical Company:

Primary Outcome Measures:
  • Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups. [ Time Frame: Active Study Duration ] [ Designated as safety issue: Yes ]
  • Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT) [ Time Frame: Day 0, 21, 28, Month 4 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Comparison of AE rates at intervals between treatment groups. [ Time Frame: Active Study Duration ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Day 0, 21, 28 and Month 4 and 9 ] [ Designated as safety issue: No ]
  • T-cell responses will be measured. [ Time Frame: Day 0, 7, 14 and 28 ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone® vaccine with JVRS-100 (3.75ug)
One vaccination on Day 0 with Fluzone® vaccine at 45 ug mixed with JVRS-100 adjuvant at 3.75ug given by IM injection to the upper deltoid.
Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.
Experimental: Fluzone® vaccine with JVRS-100 (7.5ug)
One vaccination on Day 0 with Fluzone® vaccine at 45 ug mixed with JVRS-100 adjuvant at 7.5ug given by IM injection to the upper deltoid.
Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.
Experimental: Fluzone® vaccine with JVRS-100 (25ug)
One vaccination on Day 0 with Fluzone® vaccine at 45 ug mixed with JVRS-100 adjuvant at 25ug given by IM injection to the upper deltoid.
Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.
Experimental: Fluzone® vaccine alone
One vaccination on Day 0 with Fluzone vaccine at 45 ug given by IM injection in the upper deltoid.
Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.

Detailed Description:

Approximately 472 subjects will be enrolled in this study. The study population will include elderly male and female subjects aged ≥65 years who are living in the community (including assisted living environments) and who are very fit to moderately frail.

One hundred subjects (approximately 25 in each treatment arms) will be vaccinated, and 14 days will elapse during which safety parameters are monitored by a Data and Safety Monitoring Board (DSMB), before randomizing the remaining 372 subjects.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00936468

Sponsors and Collaborators
Colby Pharmaceutical Company
Investigators
Principal Investigator: Eric Sheldon, MD Miami Research Associates, FL
Principal Investigator: Casey Johnson, DO Johnson County Clin-Trials, KS
Principal Investigator: Stephan Sharp, MD Clinical Research Associates, TN
Principal Investigator: Aurora Pop-Vicas, MD Memorial Hospital, RI
Principal Investigator: James Borders, MD Central Kentucky Research Associates, KY
Principal Investigator: Rex Biedenbender, MD Eastern Virginia Medical School, VA
Principal Investigator: Derek Muse, M.D. Jean Brown Research
  More Information

No publications provided

Responsible Party: Maggie Sisti, Juvaris
ClinicalTrials.gov Identifier: NCT00936468     History of Changes
Other Study ID Numbers: H-100-002
Study First Received: July 9, 2009
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Colby Pharmaceutical Company:
Elderly influenza vaccine

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

ClinicalTrials.gov processed this record on July 20, 2014