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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ChimeriVax™-JE vaccine

JE-VAX® vaccine

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis, ChimeriVax™-JE, JE-VAX®

Eligibility Criteria

18 Years - 48 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent obtained. Aged ≥18 to <49 years. In good general health. Available for the study duration, including all planned follow-up visits. Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: Clinically significant abnormalities on laboratory and vital sign assessments. Anaphylaxis or other serious adverse reactions Administration of another vaccine within 30 days of study treatment period. Physical examination indicating any significant medical condition. Intention to travel out of the area prior to the study visit on Day 56. Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen. Pregnancy. Excessive alcohol consumption, drug abuse. Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.

Sites / Locations

Clinical Pharamacology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ChimeriVax™-JE

JE-VAX®

Arm Description

Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.

Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Outcomes

Primary Outcome Measures

Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.

Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']

Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®

Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

Secondary Outcome Measures

Full Information

NCT ID

NCT00319592

First Posted

April 28, 2006

Last Updated

August 16, 2012

Sponsor

Sanofi

Collaborators

PRA Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00319592

Brief Title

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

Official Title

Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

PRA Health Sciences

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Japanese Encephalitis

Keywords

Japanese encephalitis, ChimeriVax™-JE, JE-VAX®

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ChimeriVax™-JE

Arm Type

Experimental

Arm Description

Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.

Arm Title

JE-VAX®

Arm Type

Active Comparator

Arm Description

Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Intervention Type

Biological

Intervention Name(s)

ChimeriVax™-JE vaccine

Other Intervention Name(s)

ChimeriVax™-JE

Intervention Description

0.5 mL, subcutaneously

Intervention Type

Biological

Intervention Name(s)

JE-VAX® vaccine

Other Intervention Name(s)

JE-VAX®

Intervention Description

1.0 mL, subcutaneously

Primary Outcome Measure Information:

Title

Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine

Description

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.

Time Frame

Day 0 (pre-vaccination) and up to Day 56 post-vaccination

Title

Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE

Description

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Time Frame

Day 0 up to Day 56 post-vaccination

Title

Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.

Description

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']

Time Frame

Day 0 (Pre-vaccination) and up to Month 12 After First Dose

Title

Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®

Description

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Time Frame

Day 0 (pre-vaccination) up to month 12 post-vaccination

Title

Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®

Description

Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

Time Frame

Day 0 up to Day 6 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent obtained. Aged ≥18 to <49 years. In good general health. Available for the study duration, including all planned follow-up visits. Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: Clinically significant abnormalities on laboratory and vital sign assessments. Anaphylaxis or other serious adverse reactions Administration of another vaccine within 30 days of study treatment period. Physical examination indicating any significant medical condition. Intention to travel out of the area prior to the study visit on Day 56. Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen. Pregnancy. Excessive alcohol consumption, drug abuse. Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy L Abdou, MD

Organizational Affiliation

PRA Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Pharamacology Center

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Japanese Encephalitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial