Japanese EncephalitisPhase 2NCT00319592
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
A Phase 2 study testing ChimeriVax™-JE vaccine and JE-VAX® vaccine in people with Japanese Encephalitis, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course. Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- ChimeriVax™-JE vaccine and JE-VAX® vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2006
- 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 18 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent obtained.
- Aged ≥18 to <49 years.
- In good general health.
- Available for the study duration, including all planned follow-up visits.
- Females must have negative pregnancy test and be using adequate form of contraception
Who cannot join
- Clinically significant abnormalities on laboratory and vital sign assessments.
- Anaphylaxis or other serious adverse reactions
- Administration of another vaccine within 30 days of study treatment period.
- Physical examination indicating any significant medical condition.
- Intention to travel out of the area prior to the study visit on Day 56.
- Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
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- Pregnancy.
- Excessive alcohol consumption, drug abuse.
- Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
- Conditions
- Japanese Encephalitis
- Being tested
- ChimeriVax™-JE vaccine, JE-VAX® vaccine
- Keywords
- Japanese encephalitis, 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™-JE vaccineBiological
Also called ChimeriVax™-JE
0.5 mL, subcutaneously
JE-VAX® vaccineBiological
Also called JE-VAX®
1.0 mL, subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| ChimeriVax™-JE | Experimental | Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. Receives: Biological: ChimeriVax™-JE vaccine |
| JE-VAX® | Active comparator | Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. Receives: Biological: JE-VAX® vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.
Measured: Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Measured: Day 0 up to Day 56 post-vaccination
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']
Measured: Day 0 (Pre-vaccination) and up to Month 12 After First Dose
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Measured: Day 0 (pre-vaccination) up to month 12 post-vaccination
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Measured: Day 0 up to Day 6 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionSep 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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Nancy L Abdou, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319592
- Sponsor's protocol ID
- H-040-008
- Status last verified
- Aug 2012
- First submitted
- 28 Apr 2006
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).
- ClinicalTrials.gov ID
- NCT00319592
- Acronym / sponsor ID
- H-040-008
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, ChimeriVax™-JE, JE-VAX®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 16 Aug 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 ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains 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™-JE vaccineSubjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. |
| JE-VAX® | Active comparator | Biological: JE-VAX® vaccineSubjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent obtained.
- Aged ≥18 to <49 years.
- In good general health.
- Available for the study duration, including all planned follow-up visits.
- Females must have negative pregnancy test and be using adequate form of contraception
Key exclusion criteria (9 listed)
- Clinically significant abnormalities on laboratory and vital sign assessments.
- Anaphylaxis or other serious adverse reactions
- Administration of another vaccine within 30 days of study treatment period.
- Physical examination indicating any significant medical condition.
- Intention to travel out of the area prior to the study visit on Day 56.
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™-JE vaccineAlso: ChimeriVax™-JE0.5 mL, subcutaneously | Biological | ChimeriVax™-JE |
| JE-VAX® vaccineAlso: JE-VAX®1.0 mL, subcutaneously | Biological | JE-VAX® |
Primary outcome
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Time frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Time frame: Day 0 up to Day 56 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Time frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Time frame: Day 0 (pre-vaccination) up to month 12 post-vaccination
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Time frame: Day 0 up to Day 6 post-vaccination
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy L Abdou, MD principal investigator
PRA Health Sciences
1 site 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™-JE vaccine and JE-VAX® vaccine in people with Japanese Encephalitis, run by Sanofi 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 5 inclusion and 9 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 20 Aug 2012. 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 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 16 Aug 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 Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine (time frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination). The study lists 5 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 20 Aug 2012.