A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

Study Overview
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Brief Summary
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The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Official Title
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A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: ChimeriVax™-JE
* Biological: JE-VAX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 18 or above Subjects in good general health. Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: History of vaccination/infection with JE or Yellow fever or other flaviviruses History of residence/travel to flavivirus endemic regions History of anaphylaxis/serious adverse reactions Administration of vaccine within 30 days of study or during treatment period Clinically significant physical exam/medical history/lab abnormalities Pregnancy Excessive alcohol/drug abuse Hypersensitivity to constituents of JE-VAX® Blood transfusion/treatment with blood product within 6months of study and during study treatment period Known/suspected immunodeficiency Compromised blood brain barrier Employees of Clinical Research Organization (CRO)/study site staff Any other condition which would exclude subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChimeriVax™-JE<br>Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms. | Biological: ChimeriVax™-JE<br>* 0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)<br>|
| Active Comparator: JE-VAX®<br>Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. | Biological: JE-VAX®<br>* 0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10. | Up to Day 60 post-first vaccination | 
| Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash. | Day 0 (Pre-vaccination) up to 60 days post-first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). | Up to Day 60 post-first vaccination | 
| Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). | Day 60 post-first vaccination |