EncephalitisPhase 2NCT00981175
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
A Phase 2 study testing Live attenuated Japanese encephalitis virus, then ChimeriVax diluent and ChimeriVax diluent, then Live attenuated Japanese encephalitis virus in people with Encephalitis and Japanese Encephalitis, run by Sanofi at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Japanese Encephalitis
- What is being tested?
- Live attenuated Japanese encephalitis virus, then ChimeriVax diluent and ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2003to Feb 2008
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At entry:
- All aspects of the protocol explained and written informed consent obtained from the subject.
- Aged ≥ 18 to < 55 years.
- In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
- Subject must be available for the study duration, including all planned follow-up visits.
- Has the subject agreed to take the following precautions to avoid insect bites for 7 days following vaccination: (a) wear long-sleeved shirts and trousers?; (b) apply N,N-Diethyl-meta-toluamide (DEET)-containing insect repellents?; (c) Sleep in screened enclosures?
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- For female subjects of childbearing potential: Negative serum pregnancy tests. An efficacious hormonal (i.e., oral, implantable or injectable) or barrier method of birth control must be used at least 1 month before Screening and Month 6 and at least 1 month after Day 28 and Month 6. These subjects will sign an agreement that birth control will be practised during the specified periods and will specify the method used. Female subjects unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
- For long-term immunogenicity follow-up period:
- Subject received an initial dose of ChimeriVax™-JE, has a baseline (Day 0) sample and at least one post-vaccination evaluable serological specimen for antibody analysis.
- All aspects of the Long-term Immunogenicity Follow-up Period explained and updated written informed consent obtained from the subject.
- In good general health, without significant medical history that may affect the efficacy endpoints or the ability to take blood samples.
Who cannot join
- A history of vaccination to Japanese encephalitis (JE). Previous vaccination will be determined by history (interview of subject) and/or by reviewing the subject's vaccination card or other official documentation (either a history of or documentation of vaccination fulfils the criterion for exclusion).
- Known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids > 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
- Clinically significant abnormalities on laboratory assessment.
- Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine.
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 56.
- Administration of another vaccine within 30 days preceding the screening visit or up to Day 56 (these subjects will be rescheduled for vaccination at a later date).
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- Physical examination indicating any clinically significant medical condition.
- Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to inoculation (subject may be rescheduled).
- Intention to travel out of the area prior to the study visit on Day 56.
- Seropositive to hepatitis C virus (HCV) or HIV or positive for hepatitis B (HBV) (antigen).
- Lactation or intended pregnancy in female subjects.
- Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g., significant hypertensive cerebrovascular disease, trauma, ischemia, infection, inflammation of the brain).
- For long-term immunogenicity follow-up period:
- History of Yellow Fever or out of study JE vaccination or known flavivirus infection since receiving ChimeriVax™-JE vaccination on Day 0 or Day 28 (during double-blind treatment period of the study). Yellow Fever/JE vaccination or flavivirus infection will be determined by history (interview of subject) and/or by reviewing the subject's medical records. Please note subjects who were flavivirus positive at Day 0 will be allowed to enrol on the study.
- Participation in another JE clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Phase 2 Study of the Safety, Immunogenicity and Duration of Immunity of ChimeriVax™-JE, Live Attenuated Vaccine in Healthy Adults
The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults.
Objectives:
Safety:
- Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese encephalitis (JE) vaccination.
Immunogenicity:
- Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE
- Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.
Read the detailed description
Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and 60 months after Day 0. No safety data will be collected in the long-term immunogenicity follow-up period.
- Conditions
- Encephalitis, Japanese Encephalitis
- Being tested
- Live attenuated Japanese encephalitis virus, then ChimeriVax diluent, ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
- Keywords
- Japanese Encephalitis, Japanese Encephalitis Vaccines, Adult
- Medical subject headings
- Encephalitis, Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated Japanese encephalitis virus, then ChimeriVax diluentBiological
Also called ChimeriVax™-JE
ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
ChimeriVax diluent, then Live attenuated Japanese encephalitis virusBiological
Also called ChimeriVax™-JE
ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo | Experimental | Participants received ChimeriVax™-JE on Day 0 and ChimeriVax diluent on Day 28 Receives: Biological: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent |
| Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine | Experimental | Participants received ChimeriVax diluent on Day 0 and ChimeriVax™-JE on Day 28. Receives: Biological: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Measured: Day 28 post-vaccination
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
Measured: Days 0 to 28 post-vaccination
Secondary outcomes (4)
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.
Measured: Month 6 pre- and post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.
Measured: Month 12 post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.
Measured: Month 24 post-vaccination
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.
Measured: Day 0 up to 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startApr 2003
- Primary completionJun 2004
- Study completionFeb 2008
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 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981175
- Sponsor's protocol ID
- H-040-005
- Status last verified
- Jul 2012
- First submitted
- 21 Sep 2009
- Last updated
- 16 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nasveld PE, Ebringer A, Elmes N, Bennett S, Yoksan S, Aaskov J, McCarthy K, Kanesa-thasan N, Meric C, Reid M. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin. 2010 Dec;6(12):1038-46. doi: 10.4161/hv.6.12.13057. Epub 2010 Dec 1.
PubMed 21150279
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Phase 2 Study of the Safety, Immunogenicity and Duration of Immunity of ChimeriVax™-JE, Live Attenuated Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00981175
- Acronym / sponsor ID
- H-040-005
- Conditions
- Encephalitis, Japanese Encephalitis
- Keywords
- Japanese Encephalitis, Japanese Encephalitis Vaccines, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 29 Apr 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 assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults.
Objectives:
Safety:
- Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to <55 years) without prior Japanese encephalitis (JE) vaccination.
Immunogenicity:
- Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE
- Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.
Detailed description
Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and 60 months after Day 0. No safety data will be collected in the long-term immunogenicity follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo | Experimental | Biological: Live attenuated Japanese encephalitis virus, then ChimeriVax diluentParticipants received ChimeriVax™-JE on Day 0 and ChimeriVax diluent on Day 28 |
| Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine | Experimental | Biological: ChimeriVax diluent, then Live attenuated Japanese encephalitis virusParticipants received ChimeriVax diluent on Day 0 and ChimeriVax™-JE on Day 28. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- All aspects of the protocol explained and written informed consent obtained from the subject.
- Aged ≥ 18 to < 55 years.
- In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
- Subject must be available for the study duration, including all planned follow-up visits.
- Has the subject agreed to take the following precautions to avoid insect bites for 7 days following vaccination: (a) wear long-sleeved shirts and trousers?; (b) apply N,N-Diethyl-meta-toluamide (DEET)-containing insect repellents?; (c) Sleep in screened enclosures?
Key exclusion criteria (16 listed)
- A history of vaccination to Japanese encephalitis (JE). Previous vaccination will be determined by history (interview of subject) and/or by reviewing the subject's vaccination card or other official documentation (either a history of or documentation of vaccination fulfils the criterion for exclusion).
- Known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids > 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
- Clinically significant abnormalities on laboratory assessment.
- Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine.
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to 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 |
|---|---|---|
| Live attenuated Japanese encephalitis virus, then ChimeriVax diluentAlso: ChimeriVax™-JEChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28 | Biological | Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo |
| ChimeriVax diluent, then Live attenuated Japanese encephalitis virusAlso: ChimeriVax™-JEChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28. | Biological | Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine |
Primary outcome
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
Time frame: Day 28 post-vaccination
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Time frame: Days 0 to 28 post-vaccination
Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
4 secondary outcomes
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Time frame: Month 6 pre- and post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Time frame: Month 12 post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Time frame: Month 24 post-vaccination
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Time frame: Day 0 up to 28 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21150279Nasveld PE, Ebringer A, Elmes N, Bennett S, Yoksan S, Aaskov J, McCarthy K, Kanesa-thasan N, Meric C, Reid M. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin. 2010 Dec;6(12):1038-46. doi: 10.4161/hv.6.12.13057. Epub 2010 Dec 1.
- Related InfoLink provided by the sponsor.
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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.
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 Live attenuated Japanese encephalitis virus, then ChimeriVax diluent and ChimeriVax diluent, then Live attenuated Japanese encephalitis virus in people with Encephalitis and Japanese Encephalitis, run by Sanofi at 1 site in Australia.
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 11 inclusion and 16 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 Jul 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 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 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 29 Apr 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?
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose (time frame: Day 28 post-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 NCT00981175, 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 16 Jul 2012.