Japanese EncephalitisPhase 3NCT00314145
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
A Phase 3 study testing ChimeriVax™-JE and JE-VAX® in people with Japanese Encephalitis, run by Sanofi at 10 sites in 2 countries.
Trial summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- ChimeriVax™-JE and JE-VAX®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2005to Nov 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
Who cannot join
- History of vaccination/infection with JE or Yellow fever or other flaviviruses
- History of residence/travel to flavivirus endemic regions
- History of anaphylaxis/serious adverse reactions
- Administration of vaccine within 30 days of study or during treatment period
- Clinically significant physical exam/medical history/lab abnormalities
- Pregnancy
Show all 13Show fewer
- Excessive alcohol/drug abuse
- Hypersensitivity to constituents of JE-VAX®
- Blood transfusion/treatment with blood product within 6months of study and during study treatment period
- Known/suspected immunodeficiency
- Compromised blood brain barrier
- Employees of Clinical Research Organization (CRO)/study site staff
- Any other condition which would exclude subject.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States5 sites
Study site
Chicago, Illinois, 60610
Study site
Dallas, Texas, 75231
Study site
Missoula, Montana, 59802
Study site
Shawnee Mission, Kansas, 66216
Study site
Tacoma, Washington, 98403
Australia5 sites
Study site
Adelaide
Study site
Melbourne
Study site
New South Wales
Study site
Queensland
Study site
Victoria
About this study
Official title: A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
- Conditions
- Japanese Encephalitis
- Being tested
- ChimeriVax™-JE, JE-VAX®
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChimeriVax™-JEBiological
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
JE-VAX®Biological
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
| Study group | Role | What they receive |
|---|---|---|
| ChimeriVax™-JE | Experimental | Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms. Receives: Biological: ChimeriVax™-JE |
| JE-VAX® | Active comparator | Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. Receives: Biological: JE-VAX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Measured: Up to Day 60 post-first vaccination
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.
Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Measured: Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Secondary outcomes (2)
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Measured: Up to Day 60 post-first vaccination
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Measured: Day 60 post-first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startNov 2005
- Primary completionJun 2006
- Study completionNov 2006
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Angles, M.D., Principal investigator, Heart of America Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314145
- Sponsor's protocol ID
- H-040-009
- Status last verified
- Dec 2012
- First submitted
- 11 Apr 2006
- Last updated
- 6 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
PubMed 20934459
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
- ClinicalTrials.gov ID
- NCT00314145
- Acronym / sponsor ID
- H-040-009
- Conditions
- Japanese Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Posted 5 Dec 2012
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 non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChimeriVax™-JE | Experimental | Biological: ChimeriVax™-JEParticipants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms. |
| JE-VAX® | Active comparator | Biological: JE-VAX®Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
Key exclusion criteria (13 listed)
- History of vaccination/infection with JE or Yellow fever or other flaviviruses
- History of residence/travel to flavivirus endemic regions
- History of anaphylaxis/serious adverse reactions
- Administration of vaccine within 30 days of study or during treatment period
- Clinically significant physical exam/medical history/lab abnormalities
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™-JE0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline) | Biological | ChimeriVax™-JE |
| JE-VAX®0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) | Biological | JE-VAX® |
Primary outcome
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time frame: Up to Day 60 post-first vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Time frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
2 secondary outcomes
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time frame: Up to Day 60 post-first vaccination
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time frame: Day 60 post-first vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20934459Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
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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.
Luis Angles, M.D. principal investigator
Heart of America Research Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ChimeriVax™-JE and JE-VAX® in people with Japanese Encephalitis, run by Sanofi at 10 sites in 2 countries.
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 3 inclusion and 13 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 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Dec 2012). 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?
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination (time frame: Up to Day 60 post-first vaccination). 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 NCT00314145, which also lists 1 linked publication.
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 6 Dec 2012.