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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone

About this trial

This is an interventional prevention trial for Influenza focused on measuring Elderly influenza vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Fluzone® vaccine with JVRS-100 (3.75ug)

Fluzone® vaccine with JVRS-100 (7.5ug)

Fluzone® vaccine with JVRS-100 (25ug)

Fluzone® vaccine alone

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups.

Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT)

Secondary Outcome Measures

Safety: Comparison of AE rates at intervals between treatment groups.

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.

T-cell responses will be measured.

Full Information

NCT ID

NCT00936468

First Posted

July 9, 2009

Last Updated

February 10, 2011

Sponsor

Colby Pharmaceutical Company

1. Study Identification

Unique Protocol Identification Number

NCT00936468

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Colby Pharmaceutical Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Elderly influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

472 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluzone® vaccine with JVRS-100 (3.75ug)

Arm Type

Experimental

Arm Description

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.

Arm Title

Fluzone® vaccine with JVRS-100 (7.5ug)

Arm Type

Experimental

Arm Description

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.

Arm Title

Fluzone® vaccine with JVRS-100 (25ug)

Arm Type

Experimental

Arm Description

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.

Arm Title

Fluzone® vaccine alone

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT)

Time Frame

Day 0, 21, 28, Month 4 and 9

Secondary Outcome Measure Information:

Title

Safety: Comparison of AE rates at intervals between treatment groups.

Time Frame

Active Study Duration

Title

Time Frame

Day 0, 21, 28 and Month 4 and 9

Title

T-cell responses will be measured.

Time Frame

Day 0, 7, 14 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: