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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00981175




Registration number
NCT00981175
Ethics application status
Date submitted
21/09/2009
Date registered
22/09/2009
Date last updated
16/07/2012

Titles & IDs
Public title
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
Scientific title
Randomised, Double-blind, Phase 2 Study of the Safety, Immunogenicity and Duration of Immunity of ChimeriVax™-JE, Live Attenuated Vaccine in Healthy Adults
Secondary ID [1] 0 0
H-040-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Encephalitis 0 0
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
Other interventions - Live attenuated Japanese encephalitis virus, then ChimeriVax diluent
Other interventions - ChimeriVax diluent, then Live attenuated Japanese encephalitis virus

Experimental: Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo - Participants received ChimeriVax™-JE on Day 0 and ChimeriVax diluent on Day 28

Experimental: Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine - Participants received ChimeriVax diluent on Day 0 and ChimeriVax™-JE on Day 28.


Other interventions: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent
ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28

Other interventions: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 28 post-vaccination
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Days 0 to 28 post-vaccination
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Month 6 pre- and post-vaccination
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Month 12 post-vaccination
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Month 24 post-vaccination
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 0 up to 28 post-vaccination

Eligibility
Key inclusion criteria
Inclusion Criteria :

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?

- 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.
Minimum age
18 Years
Maximum age
54 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria :

- 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).

- 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.

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
Crossover
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Enoggera
Recruitment postcode(s) [1] 0 0
4051 - Enoggera

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, 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.
Trial website
https://clinicaltrials.gov/show/NCT00981175
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
Other publications