Japanese EncephalitisPhase 2NCT00441259

Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

A Phase 2 study testing ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in people with Japanese Encephalitis, run by Sanofi at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Read more about this study

Who is it for?: Ages 9 months to 10 yearsHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis
What is being tested?: ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 3 sitesIndia
Study dates: Jan 2007to Dec 2011
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 9 months to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
Aged ≥ 9 months to < 10 years
In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Who cannot join

A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
Demonstration of parasitemia on malaria blood smear at Screening.
History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
hypersensitivity to thimerosal or gelatin
Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,

Show all 16Show fewer

Have a history of severe reaction to other vaccines,
Have a chronic condition requiring medication,
Intend to travel out of the area during the study period,
Have spent at least 4 weeks in a JE-endemic region,
Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
Exhibit signs of secondary or tertiary malnutrition,
Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
Have malaria infection, or who have a fever within 3 days before vaccination.
Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.

Trial locations and contacts

3 sites in 1 country.

India3 sites

Government Medical College
Baroda, 390001
Dr Atul's Child Hospital
Jaipur, Rajasthan, 302016
Maulana Azad Medical College
New Delhi, 110002

Other trials in India

About this study

Official title: Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.

Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

Conditions: Japanese Encephalitis
Being tested: ChimeriVax™-JE, Japanese Encephalitis Inactivated Mouse Brain Vaccine
Keywords: Japanese Encephalitis
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
One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously
Japanese Encephalitis Inactivated Mouse Brain VaccineBiological
Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously

Study groups in NCT00441259
Study group	Role	What they receive
JE-CV Group	Experimental	Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV) Receives: Biological: ChimeriVax™-JE
MBDV Group	Active comparator	Participants will receive the mouse brain-derived vaccine (MBDV) Receives: Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Measured: Day 14 up to Day 42 Post-vaccination
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Measured: Day 14 up to Day 42 Post-vaccination
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Measured: Day 42 Post-vaccination
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Measured: Day 42 Post Dose 1

Secondary outcomes (2)

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Measured: Day 42 Post Dose 1
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Measured: Day 42 Post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Dec 2011

First posted28 Feb 2007 (estimated)
Study startJan 2007
Primary completionFeb 2011
Study completionDec 2011

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: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441259
Sponsor's protocol ID: H-040-004
Status last verified: Jul 2012
First submitted: 27 Feb 2007
Last updated: 27 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Japanese Encephalitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.
ClinicalTrials.gov ID: NCT00441259
Acronym / sponsor ID: H-040-004
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Feb 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 Feb 2007 (estimated)
Results: Posted 27 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
JE-CV Group	Experimental	Biological: ChimeriVax™-JEParticipants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)
MBDV Group	Active comparator	Biological: Japanese Encephalitis Inactivated Mouse Brain VaccineParticipants will receive the mouse brain-derived vaccine (MBDV)

Who may qualify

Ages: 9 months to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
Aged ≥ 9 months to < 10 years
In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Key exclusion criteria (16 listed)

A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
Demonstration of parasitemia on malaria blood smear at Screening.
History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
hypersensitivity to thimerosal or gelatin
Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,

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™-JEOne dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously	Biological	JE-CV Group
Japanese Encephalitis Inactivated Mouse Brain VaccineTwo doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously	Biological	MBDV Group

Primary outcome

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 42 Post-vaccination
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 42 Post Dose 1
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).

2 secondary outcomes

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 42 Post Dose 1
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 42 Post-vaccination

Results and safety

Results posted to the registry on 27 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ChimeriVax™-JE	48	48
Mouse Brain Derived Vaccine	48	48

Primary outcome: Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame: Day 14 up to Day 42 Post-vaccination. Number. Unit: Participants

Measure	ChimeriVax™-JE n = 48	Mouse Brain Derived Vaccine n = 48
Nasopharyngitis (All; N = 48, 48)	2	2 (0 to 0)
Otitis Media Acute (All; N = 48, 48)	1	0 (0 to 0)
Diarrhea Infectious (All; N = 48, 48)	1	0 (0 to 0)
Dysentery (All; N = 48, 48)	1	0 (0 to 0)
Hepatitis A (All; N = 48, 48)	1	0 (0 to 0)
Rash Pustular (All; N = 48, 48)	1	0 (0 to 0)
Tonsillitis (All; N = 48, 48)	1	0 (0 to 0)
Upper Respiratory Tract Infection (All; N=48, 48)	1	0 (0 to 0)

Population analysed: Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.

Primary outcome: Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame: Day 14 up to Day 42 Post-vaccination. Number. Unit: Participants

Measure	ChimeriVax™-JE n = 48	Mouse Brain Derived Vaccine n = 48
Nasopharyngitis (All; N = 48, 48)	2	2 (0 to 0)
Upper Respiratory Tract Infection (All; N =48, 48)	1	0 (0 to 0)
Impetigo (All; N = 48, 48)	0	1 (0 to 0)
Pharyngitis (All; N = 48, 48)	0	1 (0 to 0)
Diarrhea (All; N = 48, 48)	1	2 (0 to 0)
Vomiting (All; N = 48, 48)	1	1 (0 to 0)
Hematochezia (All; N = 48, 48)	1	0 (0 to 0)
Mucous Stools (All; N = 48, 48)	1	0 (0 to 0)

Population analysed: Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.

Primary outcome: Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame: Day 42 Post-vaccination. Number. Unit: Participants

Measure	ChimeriVax™-JE n = 33	Mouse Brain Derived Vaccine n = 35
Homologous JE-CV virus PRNT (N = 33, 0)	33	NA (0 to 0)
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA	8
JE-CV PRNT (N = 33, 35)	33	33 (0 to 0)
Nakayama PRNT (N = 32, 35)	8	8 (0 to 0)
Indian WT virus PRNT (N = 33, 35)	27	26 (0 to 0)

Population analysed: Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.

Primary outcome: Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame: Day 42 Post Dose 1. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	ChimeriVax™-JE n = 34	Mouse Brain Derived Vaccine n = 35
Homologous JE-CV virus PRNT (N = 34, 0)	313.5 (40 to 5120)	NA (NA to NA)
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA (NA to NA)	8.0 (5 to 160)
JE-CV PRNT (N = 34, 35)	313.5 (40 to 5120)	49.7 (5 to 320)
Nakayama PRNT (N = 33, 35)	7.8 (5 to 160)	8.0 (5 to 160)
Indian WT virus PRNT (N = 34, 35)	60.1 (5 to 2560)	17.1 (5 to 320)

Population analysed: Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ChimeriVax™-JE	0 of 48 (0%)	6 of 48 (12.5%)	Not reported
Mouse Brain Derived Vaccine	0 of 48 (0%)	5 of 48 (10.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 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.

Anand Dubey, M.D principal investigator

Maulana Azad Medical College, New Delhi, India

Bakul B. Javadekar, M.D. principal investigator

Government Medical College, Baroda, India

Atul Shanker, Dr. principal investigator

Dr Atul's Child Hospital, Jaipur, Rajasthan, India

3 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™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in people with Japanese Encephalitis, run by Sanofi at 3 sites in India.

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 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 27 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 3 sites in India. 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 27 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 With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine (time frame: Day 14 up to Day 42 Post-vaccination). The study lists 4 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 NCT00441259.

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 27 Aug 2012.