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

Sanofi820 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

820

Conditions

Japanese Encephalitis

Interventions

ChimeriVax™-JEBIOLOGICAL

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

JE-VAX®BIOLOGICAL

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (10)

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Shawnee Mission, Kansas, United States

Unnamed facility

Missoula, Montana, United States

Unnamed facility

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination

Secondary Outcomes

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).

Time frame: 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).

Time frame: Day 60 post-first vaccination

Data from ClinicalTrials.gov

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