A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults

Phase 2

Completed

• Conditions: Encephalitis; Japanese Encephalitis
• Interventions: Biological: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent; Biological: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus

• Registration Number: NCT00981175
• Lead Sponsor: Sanofi

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.

Detailed Description

Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and 60 months after Day 0. No safety data will be collected in the long-term immunogenicity follow-up period.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-06
• Study Completion: 2008-02
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Results First Submitted: 2011-04-05
• Results First Submitted QC: 2011-04-05
• Results First Posted: 2011-04-29
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo	Live attenuated Japanese encephalitis virus, then ChimeriVax diluent	Participants received ChimeriVax™-JE on Day 0 and ChimeriVax diluent on Day 28
Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine	ChimeriVax diluent, then Live attenuated Japanese encephalitis virus	Participants received ChimeriVax diluent on Day 0 and ChimeriVax™-JE on Day 28.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose	Day 28 post-vaccination	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.
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.	Days 0 to 28 post-vaccination	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.

Secondary Outcome Measures

Name	Time	Method
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.	Month 6 pre- and post-vaccination	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.
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.	Month 12 post-vaccination	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.
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.	Month 24 post-vaccination	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.
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.	Day 0 up to 28 post-vaccination	Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.