InfluenzaPhase 2NCT00936468
Safety, Tolerability and Immunogenicity of Fluzone® With and Without JVRS-100 in Elderly Subjects
A Phase 2 study testing Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone in people with Influenza, run by Colby Pharmaceutical Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
About this study
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone
- Keywords
- Elderly influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluzone® vaccine with JVRS-100 (3.75ug) | Experimental | 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. Receives: Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone |
| Fluzone® vaccine with JVRS-100 (7.5ug) | Experimental | 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. Receives: Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone |
| Fluzone® vaccine with JVRS-100 (25ug) | Experimental | 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. Receives: Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone |
| Fluzone® vaccine alone | Experimental | One vaccination on Day 0 with Fluzone vaccine at 45 ug given by IM injection in the upper deltoid. Receives: Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups.
Measured: Active Study Duration
Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT)
Measured: Day 0, 21, 28, Month 4 and 9
Secondary outcomes (3)
Safety: Comparison of AE rates at intervals between treatment groups.
Measured: Active Study Duration
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.
Measured: Day 0, 21, 28 and Month 4 and 9
T-cell responses will be measured.
Measured: Day 0, 7, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colby Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Sheldon, MD, Principal investigator, Miami Research Associates, FLCasey Johnson, DO, Principal investigator, Johnson County Clin-Trials, KSStephan Sharp, MD, Principal investigator, Clinical Research Associates, TNAurora Pop-Vicas, MD, Principal investigator, Memorial Hospital, RIJames Borders, MD, Principal investigator, Central Kentucky Research Associates, KYRex Biedenbender, MD, Principal investigator, Eastern Virginia Medical School, VADerek Muse, M.D., Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936468
- Sponsor's protocol ID
- H-100-002
- Status last verified
- Feb 2011
- First submitted
- 9 Jul 2009
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00936468
- Acronym / sponsor ID
- H-100-002
- Conditions
- Influenza
- Keywords
- Elderly influenza vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Colby Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluzone® vaccine with JVRS-100 (3.75ug) | Experimental | Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneOne 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. |
| Fluzone® vaccine with JVRS-100 (7.5ug) | Experimental | Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneOne 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. |
| Fluzone® vaccine with JVRS-100 (25ug) | Experimental | Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneOne 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. |
| Fluzone® vaccine alone | Experimental | Biological: Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneOne vaccination on Day 0 with Fluzone vaccine at 45 ug given by IM injection in the upper deltoid. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone® vaccine with JVRS-100 adjuvant or Fluzone aloneOne 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. | Biological | Fluzone® vaccine alone, Fluzone® vaccine with JVRS-100 (25ug), Fluzone® vaccine with JVRS-100 (3.75ug), Fluzone® vaccine with JVRS-100 (7.5ug) |
Primary outcome
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
Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT)
Time frame: Day 0, 21, 28, Month 4 and 9
3 secondary outcomes
Safety: Comparison of AE rates at intervals between treatment groups.
Time frame: Active Study Duration
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
T-cell responses will be measured.
Time frame: Day 0, 7, 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sheldon, MD principal investigator
Miami Research Associates, FL
Casey Johnson, DO principal investigator
Johnson County Clin-Trials, KS
Stephan Sharp, MD principal investigator
Clinical Research Associates, TN
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone in people with Influenza, run by Colby Pharmaceutical Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.