Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

Phase 2

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: ChimeriVax™ diluent (Placebo); Biological: Live attenuated Japanese encephalitis virus

• Registration Number: NCT00981630
• Lead Sponsor: Sanofi

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.

Detailed Description

All participants will received a single dose of study vaccine, ChimeriVax™-JE or placebo on Day 0. The double-blind treatment phase will last 30 days, with follow-up visits at 6 and 12 months.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-02
• Study Completion: 2007-11
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Status Verified: 2012-11
• Results First Submitted: 2012-11-06
• Results First Submitted QC: 2012-11-06
• Last Update Submitted: 2012-11-06
• Results First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ChimeriVax™ diluent (Placebo)	Participants received ChimeriVax diluent, 0.5 mL on Day 0.
ChimeriVax™-JE Dose Level 1	Live attenuated Japanese encephalitis virus	Participants received ChimeriVax™-JE (Japanese Encephalitis) a dose of 3.0 log10 Plaque-forming units (PFU) on Day 0.
ChimeriVax™-JE Dose Level 2	Live attenuated Japanese encephalitis virus	Participants received ChimeriVax™-JE a dose of 4.0 log10 PFU on Day 0.
ChimeriVax™-JE Dose Level 3	Live attenuated Japanese encephalitis virus	Participants received ChimeriVax™-JE a dose of 5.0 log10 PFU on Day 0.

Primary Outcome Measures

Name	Time	Method
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	Day 11 and Day 30 post-vaccination	Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
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	Day 30 post-vaccination	Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
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	Day 0 (post-vaccination) up to Day 30 post-vaccination	Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo	Day 11 and Day 30 post-vaccination	Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.
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	Day 30 post-vaccination	The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.
Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo	Day 30 up to 12 months post-vaccination	Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer \< 1:10.