Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

Phase 2

Completed

• Conditions: Japanese Encephalitis; Yellow Fever
• Interventions: Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus; Biological: Yellow fever virus; Live attenuated Japanese encephalitis virus

• Registration Number: NCT00982137
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.

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

All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-04
• Study Completion: 2007-03
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Results First Submitted: 2012-07-11
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Results First Posted: 2012-09-20
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChimeriVax™-JE then STAMARIL®	Live attenuated Japanese encephalitis virus; Yellow fever virus	Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30
STAMARIL® then ChimeriVax™-JE	Yellow fever virus; Live attenuated Japanese encephalitis virus	Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30
ChimeriVax™-JE and STAMARIL®, then Diluent	Live attenuated Japanese encephalitis virus; Yellow fever virus	Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30.
Diluent then ChimeriVax™-JE and STAMARIL®	Live attenuated Japanese encephalitis virus; Yellow fever virus	Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.	Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)	Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.; The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.	Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)	Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.; The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination	Day 0 (Pre-vaccination) through Day 30 post-vaccination	Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo	Day 0 up to Day 60 post-vaccination	Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.; All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.	Day 0 through 6 months post-vaccination	Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.; Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo	Day 0 through 6 months post-vaccination	Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.; Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).