InfluenzaPhase 1H-100-001NCT00662272
Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant
A Phase 1 study testing Fluzone vaccine with JVRS-100 adjuvant and Fluzone vaccine in people with Influenza, run by Colby Pharmaceutical Company at 2 sites in United States.
Trial summary
This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone vaccine with JVRS-100 adjuvant and Fluzone vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Dec 2009
- Phase
- Phase 1
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to understand the study and provide written informed consent
- 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
Who cannot join
- have allergy to eggs or other components of the vaccine
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
About this study
Official title: Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With Ascending Doses of JVRS-100 Adjuvant
This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.
Read the detailed description
The purpose of this trial is to evaluate the safety and tolerability of graded, ascending doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.
- Conditions
- Influenza
- Being tested
- Fluzone vaccine with JVRS-100 adjuvant, Fluzone vaccine
- Keywords
- Flu, Influenza vaccine, Adjuvant, Safety of an adjuvanted vaccine, Immune response to an adjuvanted 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 adjuvantBiological
Also called Fluzone vaccine, 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 vaccineBiological
Also called Flu vaccine
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
Fluzone vaccineBiological
Also called Flu vaccination
One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant Receives: Biological: Fluzone vaccine with JVRS-100 adjuvant |
| 2 | Active comparator | Arm includes treatment with half adult dose of Fluzone® vaccine Receives: Biological: Fluzone vaccine |
| 3 | Active comparator | Arm includes treatment with full adult dose Fluzone® vaccine Receives: Biological: Fluzone vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of adverse events between treatment groups
Measured: Active Study Duration
Dose-response analysis of HAI geometric mean titers (GMT)
Measured: 5 time points
Secondary outcomes (2)
Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort.
Measured: 2 periods
Seroprotection and seroconversion rates to various antigens, distribution of antibody titers, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against "drifted" strains.
Measured: 5 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colby Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas P Monath, MD, Study director, Medical Monitor for Juvaris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662272
- Sponsor's protocol ID
- H-100-001
- Acronym
- H-100-001
- Status last verified
- Mar 2010
- First submitted
- 15 Apr 2008
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10689150Thompson 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.
PubMed 12517228Monto 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.
PubMed 1202957Barker 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.
PubMed 3717461Glezen WP. Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev. 1982;4:25-44. doi: 10.1093/oxfordjournals.epirev.a036250. No abstract available.
PubMed 6754408Pfleiderer 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.
PubMed 11738754Hilleman 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.
PubMed 12163258CBER. 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.
PubMed 16874296de 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.
PubMed 15088777Beyer 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.
PubMed 15163500Banzhoff 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.
PubMed 12679609CBER. Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Guidance. September 2007. Available at hhtp://www.fda.gov/cber/guidelines.htm
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With Ascending Doses of JVRS-100 Adjuvant
- ClinicalTrials.gov ID
- NCT00662272
- Acronym / sponsor ID
- H-100-001 / H-100-001
- Conditions
- Influenza
- Keywords
- Flu, Influenza vaccine, Adjuvant, Safety of an adjuvanted vaccine, Immune response to an adjuvanted vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Colby Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Apr 2008 (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 assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.
Detailed description
The purpose of this trial is to evaluate the safety and tolerability of graded, ascending doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Fluzone vaccine with JVRS-100 adjuvantArm includes treatment with Fluzone® vaccine mixed with study product JVRS-100 adjuvant |
| 2 | Active comparator | Biological: Fluzone vaccineArm includes treatment with half adult dose of Fluzone® vaccine |
| 3 | Active comparator | Biological: Fluzone vaccineArm includes treatment with full adult dose Fluzone® vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- able to understand the study and provide written informed consent
- 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
Key exclusion criteria (18 listed)
- have allergy to eggs or other components of the vaccine
- 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.
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 adjuvantAlso: Fluzone vaccine, adjuvantOne 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. | Biological | 1 |
| Fluzone vaccineAlso: Flu vaccineOne vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid. | Biological | 2 |
| Fluzone vaccineAlso: Flu vaccinationOne vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid. | Biological | 3 |
Primary outcome
Comparison of adverse events between treatment groups
Time frame: Active Study Duration
Dose-response analysis of HAI geometric mean titers (GMT)
Time frame: 5 time points
2 secondary outcomes
Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort.
Time frame: 2 periods
Seroprotection and seroconversion rates to various antigens, distribution of antibody titers, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against "drifted" strains.
Time frame: 5 time points
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 17 Mar 2010.
- Background: PubMed 10689150Betts RF, Treanor JJ. Approaches to improved influenza vaccination. Vaccine. 2000 Feb 25;18(16):1690-5. doi: 10.1016/s0264-410x(99)00508-3.
- Background: PubMed 12517228Thompson 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.
- Background: PubMed 1202957Monto 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.
- Background: PubMed 3717461Barker 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.
- Background: PubMed 6754408Glezen WP. Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev. 1982;4:25-44. doi: 10.1093/oxfordjournals.epirev.a036250. No abstract available.
- Background: PubMed 11738754Pfleiderer 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.
- Background: PubMed 12163258Hilleman 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.
- BackgroundCBER. 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
- Background: PubMed 16874296Advisory 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.
- Background: PubMed 15088777de 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.
- Background: PubMed 15163500Beyer 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.
- Background: PubMed 12679609Banzhoff 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.
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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.
Thomas P Monath, MD study director
Medical Monitor for Juvaris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluzone vaccine with JVRS-100 adjuvant and Fluzone vaccine in people with Influenza, run by Colby Pharmaceutical Company at 2 sites in United States.
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 5 inclusion and 18 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 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Comparison of adverse events 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?
On the ClinicalTrials.gov record for NCT00662272, which also lists 13 linked publications.
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 17 Mar 2010.