West Nile FeverPhase 2WinVax004NCT00746798
Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
A Phase 2 study testing ChimeriVax-WN02 vaccine in people with West Nile Fever, run by Sanofi Pasteur, a Sanofi Company at 15 sites in United States.
Trial summary
The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- West Nile Fever
- What is being tested?
- ChimeriVax-WN02 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 479 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Medically stable, ambulatory male or female ≥ 50 years of age.
- Attend all scheduled visits and to comply with all study procedures.
- Negative serum pregnancy test at Screening, and a negative urine pregnancy test on Day 0.
Who cannot join
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg of prednisone or equivalent), or depot preparation within the previous 3 months. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within 3 months before enrollment or planned administration during treatment period of study.
- Presence of acute or chronic illness associated with an oral temperature of >38.0 °C or requiring hospitalization at time of enrollment.
- Any of the following serological findings at Screening:
- positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive human immunodeficiency virus (HIV).
- Personal or family history of thymic pathology (e.g., thymoma), thymectomy, or myasthenia.
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- History of significant allergic reaction to the vaccine components
- Asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen.
- Active or potentially progressive neurologic disease or injury including but not limited to: Parkinson's, Guillain Barré, epilepsy, seizures (except febrile seizures under the age of 2), cerebrovascular accident, head trauma requiring hospitalization within the preceding 3 years, or any other neurologic condition thought to impact the integrity of the blood brain barrier.
- Clinically significant abnormal ECG findings at Screening
- Impaired hepatic function, and/or clinically significant or unexplained elevations of alanine aminotransferase (ALT, SGPT), or aspartate aminotransferase (AST, SGOT) > 3X the upper limit of normal.
- Impaired renal function, as shown by but not limited to, serum creatinine >2.0 mg/dL.
- Impaired hematopoietic function and/or clinically significant hematological laboratory abnormalities.
- A history of alcohol or drug abuse within 12 months prior to study entry.
- Pregnant or lactating women and women of childbearing potential who are not using an acceptable method of contraception at least 28 days prior to enrollment. Post menopausal women will be considered not of childbearing potential 1 year after last menstrual period.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the Investigator affects the ability of the subject to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
- Any other condition, which in the Investigator's judgment, might result in an increased risk to the subject, or would affect the subject's participation in the study.
- Participation in another clinical trial investigating a vaccine, drug or medical procedure in the 30 days preceding informed consent.
- Any vaccine administered within 30 days prior to study vaccination. Note: Influenza vaccine can be administered 1 week preceding study vaccination.
- Planned participation in another clinical trial during the present trial period.
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Research site personnel or their family members cannot be enrolled as subjects in this trial.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Advanced Clinical Research Inst.
Anaheim, California, 92801
Advanced Clinical Research- Idaho
Boise, Idaho, 83642
Big Sky Clinical Research
Butte, Montana, 59701
Lynn Health Science Institute
Colorado Springs, Colorado, 80909
Research Across America
Dallas, Texas, 75234
Odyssey Research
Fargo, North Dakota, 88104
Benchmark
Fort Worth, Texas, 76135
Idaho Falls Infectious diseases
Idaho Falls, Idaho, 83404
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Infectious Disease Specialists, PC
Missoula, Montana, 59802
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Vince & Associates
Overland Park, Kansas, 66211
Radiant Research
Salt Lake City, Utah, 84107
Miami Research
South Miami, Florida, 33143
Bio-Kinetic
Springfield, Missouri, 65802
About this study
Official title: Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults.
The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.
Read the detailed description
Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.
- Conditions
- West Nile Fever
- Being tested
- ChimeriVax-WN02 vaccine, Placebo
- Keywords
- West Nile Fever, ChimeriVax, West Nile Virus Vaccine
- Medical subject headings
- West Nile Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChimeriVax-WN02 vaccineBiological
low dose, approximately 4 x 3log10, given one time subcutaneously
ChimeriVax-WN02 vaccineBiological
medium dose, approximately 4 x 4log10, given one time
ChimeriVax-WN02 vaccineBiological
high dose, approximately 4 x 5log10, given one time subcutaneously
PlaceboBiological
0.9%Normal Saline for Injection, given one time subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| ChimeriVax WN02 vaccine, low dose | Experimental | Participants randomized to receive ChimeriVax WN02 vaccine, low dose Receives: Biological: ChimeriVax-WN02 vaccine |
| ChimeriVax-WN02 vaccine, medium dose | Experimental | Participants randomized to receive ChimeriVax-WN02 vaccine, medium dose Receives: Biological: ChimeriVax-WN02 vaccine |
| ChimeriVax-WN02 vaccine, high dose | Experimental | Participants randomized to receive ChimeriVax-WN02 vaccine, high dose Receives: Biological: ChimeriVax-WN02 vaccine |
| Placebo | Placebo comparator | Participants randomized to receive Placebo (Saline) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Measured: Day 0 and Day 28 post-vaccination
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.
Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10.
Measured: Day 0 and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Measured: Day 0 up to Day 14 post-vaccination
Secondary outcomes (1)
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.
Measured: Day 2 up to Day 14 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for West Nile FeverStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746798
- Sponsor's protocol ID
- H-244-004
- Acronym
- WinVax004
- Status last verified
- Mar 2015
- First submitted
- 2 Sep 2008
- Last updated
- 3 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults.
- ClinicalTrials.gov ID
- NCT00746798
- Acronym / sponsor ID
- WinVax004 / H-244-004
- Conditions
- West Nile Fever
- Keywords
- West Nile Fever, ChimeriVax, West Nile Virus Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Posted 2 Nov 2011
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 study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.
Detailed description
Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ChimeriVax WN02 vaccine, low dose | Experimental | Biological: ChimeriVax-WN02 vaccineParticipants randomized to receive ChimeriVax WN02 vaccine, low dose |
| ChimeriVax-WN02 vaccine, medium dose | Experimental | Biological: ChimeriVax-WN02 vaccineParticipants randomized to receive ChimeriVax-WN02 vaccine, medium dose |
| ChimeriVax-WN02 vaccine, high dose | Experimental | Biological: ChimeriVax-WN02 vaccineParticipants randomized to receive ChimeriVax-WN02 vaccine, high dose |
| Placebo | Placebo comparator | Biological: PlaceboParticipants randomized to receive Placebo (Saline) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Medically stable, ambulatory male or female ≥ 50 years of age.
- Attend all scheduled visits and to comply with all study procedures.
- Negative serum pregnancy test at Screening, and a negative urine pregnancy test on Day 0.
Key exclusion criteria (22 listed)
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg of prednisone or equivalent), or depot preparation within the previous 3 months. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within 3 months before enrollment or planned administration during treatment period of study.
- Presence of acute or chronic illness associated with an oral temperature of >38.0 °C or requiring hospitalization at time of enrollment.
- Any of the following serological findings at Screening:
- positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive human immunodeficiency virus (HIV).
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 |
|---|---|---|
| ChimeriVax-WN02 vaccinelow dose, approximately 4 x 3log10, given one time subcutaneously | Biological | ChimeriVax WN02 vaccine, low dose |
| ChimeriVax-WN02 vaccinemedium dose, approximately 4 x 4log10, given one time | Biological | ChimeriVax-WN02 vaccine, medium dose |
| ChimeriVax-WN02 vaccinehigh dose, approximately 4 x 5log10, given one time subcutaneously | Biological | ChimeriVax-WN02 vaccine, high dose |
| Placebo0.9%Normal Saline for Injection, given one time subcutaneously | Biological | Placebo |
Primary outcome
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Time frame: Day 0 and Day 28 post-vaccination
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test. Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10.
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time frame: Day 0 up to Day 14 post-vaccination
1 secondary outcome
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time frame: Day 2 up to Day 14 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for West Nile Fever
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High-Titer Neutralizing Plasma for West Nile Fever in Hospitalized Patients
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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.
Medical Director study director
Sanofi Pasteur Inc
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChimeriVax-WN02 vaccine in people with West Nile Fever, run by Sanofi Pasteur, a Sanofi Company at 15 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 4 inclusion and 22 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine (time frame: Day 0 and Day 28 post-vaccination). The study lists 3 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 3 Apr 2015.