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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00981630




Registration number
NCT00981630
Ethics application status
Date submitted
21/09/2009
Date registered
22/09/2009
Date last updated
5/12/2012

Titles & IDs
Public title
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
Scientific title
Randomised, Double-blind, Placebo Controlled Phase II, Dose-ranging Study of the Safety, Tolerability and Immunogenicity of Live Attenuated ChimeriVax™-JE Vaccine (Lyophilised)
Secondary ID [1] 0 0
H-040-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Japanese Encephalitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Live attenuated Japanese encephalitis virus
Treatment: Other - Live attenuated Japanese encephalitis virus
Treatment: Other - Live attenuated Japanese encephalitis virus
Treatment: Other - ChimeriVax™ diluent (Placebo)

Experimental: ChimeriVax™-JE Dose Level 1 - Participants received ChimeriVax™-JE (Japanese Encephalitis) a dose of 3.0 log10 Plaque-forming units (PFU) on Day 0.

Experimental: ChimeriVax™-JE Dose Level 2 - Participants received ChimeriVax™-JE a dose of 4.0 log10 PFU on Day 0.

Experimental: ChimeriVax™-JE Dose Level 3 - Participants received ChimeriVax™-JE a dose of 5.0 log10 PFU on Day 0.

Placebo comparator: Placebo - Participants received ChimeriVax diluent, 0.5 mL on Day 0.


Treatment: Other: Live attenuated Japanese encephalitis virus
0.5 mL,Subcutaneous

Treatment: Other: Live attenuated Japanese encephalitis virus
0.5 mL, Subcutaneous

Treatment: Other: Live attenuated Japanese encephalitis virus
0.5 mL, Subcutaneous

Treatment: Other: ChimeriVax™ diluent (Placebo)
0.5 mL, Subcutaneous
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo
Timepoint [1] 0 0
Day 11 and Day 30 post-vaccination
Primary outcome [2] 0 0
Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Timepoint [2] 0 0
Day 30 post-vaccination
Primary outcome [3] 0 0
Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Timepoint [3] 0 0
Day 0 (post-vaccination) up to Day 30 post-vaccination
Secondary outcome [1] 0 0
Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Timepoint [1] 0 0
Day 11 and Day 30 post-vaccination
Secondary outcome [2] 0 0
Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo
Timepoint [2] 0 0
Day 30 post-vaccination
Secondary outcome [3] 0 0
Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo
Timepoint [3] 0 0
Day 30 up to 12 months post-vaccination

Eligibility
Key inclusion criteria
Inclusion Criteria :

* All aspects of the protocol explained and written informed consent obtained from the participant.
* Aged =18 to < 49 years.
* In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
* Participant must be available for the study duration, including all planned follow-up visits.
* Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate.
* For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal [at least one year since last menstrual period]).
Minimum age
18 Years
Maximum age
48 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria :

* A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject).
* Previous or current military service.
* History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more.
* 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, in the last three months or during the trial (up to Day 30).
* History of thymoma, thymic surgery (removal) or myasthenia gravis.
* Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe criteria described in the toxicity gradings for laboratory values).
* Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, hymenoptera (bee family) stings, or drugs (including vaccines).
* 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 30.
* Administration of another vaccine or antiviral within 30 days preceding the screening visit or up to Day 30 (these subjects will be rescheduled for vaccination at a later date).
* 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 (participant may be rescheduled).
* Intention to travel out of the area prior to the study visit on Day 30.
* Seropositive to hepatitis C virus or HIV or positive for Hepatitis B Surface 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, ischaemia, infection, inflammation of the brain).
* Intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 30.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
QLD 4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo.

Primary Objectives:

Safety:

* To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).

Immunogenicity:

* To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity.
* To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.
Trial website
https://clinicaltrials.gov/study/NCT00981630
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Sanofi Pasteur Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00981630