Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
NCT ID: NCT00982137
Last Updated: 2012-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2004-07-31
2007-03-31
Brief Summary
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Objectives:
Safety:
* Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow fever (YF) vaccination.
Immunogenicity:
* Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE administered concurrently, one month before or one month after STAMARIL® to adult volunteers without prior JE (or YF) vaccination.
* Assess the durability of the immune response in adult volunteers 6 months after administration of ChimeriVax™-JE and STAMARIL®.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ChimeriVax™-JE then STAMARIL®
Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30
Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.
STAMARIL® then ChimeriVax™-JE
Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30
Yellow fever virus; Live attenuated Japanese encephalitis virus
STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.
ChimeriVax™-JE and STAMARIL®, then Diluent
Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.
Diluent then ChimeriVax™-JE and STAMARIL®
Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virus
Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
Interventions
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Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.
Yellow fever virus; Live attenuated Japanese encephalitis virus
STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virus
Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 18 to ≤ 55 years at Day 0.
* 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.
* The participant must agree 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.
* Female participants of childbearing potential must have a negative serum pregnancy test. An efficacious hormonal method (i.e., oral, implantable or injectable) of contraception or an intrauterine contraceptive device (IUCD) must be used at least 1 month before Screening and at least 1 month after Day 60. These participants will sign an agreement that contraception will be 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 or hysterectomy).
Exclusion Criteria
* Impaired immunity, including known or suspected immunodeficiency (e.g., human immunodeficiency virus \[HIV\] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (including corticosteroids \> 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
* Clinically significant abnormal laboratory assessment results.
* Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine, chicken or eggs or egg protein.
* 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 60.
* Administration of another vaccine within 28 days of receiving study vaccination.
* Physical examination indicating any clinically significant medical condition including any short-lived or long-standing illness which has become more severe.
* 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 60.
* Seropositive to hepatitis C virus (HCV) or HIV or positive for hepatitis B virus (HBV) (antigen).
* Lactation or intended pregnancy in female participants.
* 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).
18 Years
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Herston, Queensland, Australia
Countries
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References
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Nasveld PE, Marjason J, Bennett S, Aaskov J, Elliott S, McCarthy K, Kanesa-Thasan N, Feroldi E, Reid M. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1.
Related Links
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Related Info
Other Identifiers
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H-040-006
Identifier Type: -
Identifier Source: org_study_id