West Nile Virus DiseasePhase 1NCT00707642
Safety Study of HBV-002 West Nile Vaccine in Healthy Adults
A Phase 1 study testing WN-80E in people with West Nile Virus Disease, run by Hawaii Biotech, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- West Nile Virus Disease
- What is being tested?
- WN-80E
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation [hematology, biochemistry, urinalysis])
- Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table
Who cannot join
- Current active infection process including URI or influenza
- Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies
- History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE)
- Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines
- History of alcohol or other substance abuse within 1 year of screening
- Use of corticosteroids or immunosuppressive drugs within 30 days of screening (Use of topical or nasal corticosteroids are not excluded.)
Show all 11Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Administration of immunoglobulins within three months of the first vaccination or planned during the study period
- Receipt of any vaccines or investigational or non-registered product other than HBV-002 within 30 days prior to screening or planned receipt throughout the study.
- Receipt of another study vaccines within 30 days prior to screening
- Receipt of blood products within 6 months of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Honolulu, Hawaii, 96813
About this study
Official title: Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.
Read the detailed description
West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.
- Conditions
- West Nile Virus Disease
- Being tested
- WN-80E
- Keywords
- West Nile Virus, West Nile Vaccine, West Nile virus disease, Hawaii Biotech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WN-80EBiological
Also called HBV-002 vaccine
Three injections of the study vaccine [Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)] given one month apart
WN-80EBiological
Also called HBV-002 vaccine
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
WN-80EBiological
Also called HBV-002 vaccine
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
WN-80EBiological
Also called HBV-002 vaccine
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg) Receives: Biological: WN-80E |
| 2 | Experimental | Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg) Receives: Biological: WN-80E |
| 3 | Experimental | High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg) Receives: Biological: WN-80E |
| 4 | Experimental | High Dose WN-80E API (50 µg), no adjuvant Receives: Biological: WN-80E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
Measured: 38 weeks
Secondary outcomes (1)
To assess the immunogenicity of HBV-002
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for West Nile Virus DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jay Winship, M.D., Study director, Hawaii Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707642
- Sponsor's protocol ID
- HBV-002-C-101
- Status last verified
- Jun 2009
- First submitted
- 29 Jun 2008
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00707642
- Acronym / sponsor ID
- HBV-002-C-101
- Conditions
- West Nile Virus Disease
- Keywords
- West Nile Virus, West Nile Vaccine, West Nile virus disease, Hawaii Biotech
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hawaii Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Jul 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.
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.
Detailed description
West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: WN-80ELow Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg) |
| 2 | Experimental | Biological: WN-80EMedium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg) |
| 3 | Experimental | Biological: WN-80EHigh Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg) |
| 4 | Experimental | Biological: WN-80EHigh Dose WN-80E API (50 µg), no adjuvant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation [hematology, biochemistry, urinalysis])
- Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table
Key exclusion criteria (11 listed)
- Current active infection process including URI or influenza
- Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies
- History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE)
- Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines
- History of alcohol or other substance abuse within 1 year of screening
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 |
|---|---|---|
| WN-80EAlso: HBV-002 vaccineThree injections of the study vaccine [Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)] given one month apart | Biological | 1 |
| WN-80EAlso: HBV-002 vaccineThree injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart | Biological | 2 |
| WN-80EAlso: HBV-002 vaccineThree injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart | Biological | 3 |
| WN-80EAlso: HBV-002 vaccineThree injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart | Biological | 4 |
Primary outcome
Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
Time frame: 38 weeks
1 secondary outcome
To assess the immunogenicity of HBV-002
Time frame: 38 weeks
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 16 Jun 2009.
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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.
Jay Winship, M.D. study director
Hawaii Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WN-80E in people with West Nile Virus Disease, run by Hawaii Biotech, Inc. at 1 site 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 2 inclusion and 11 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 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects (time frame: 38 weeks). 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 16 Jun 2009.