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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ChimeriVax™-JE

JE-VAX®

About this trial

This is an interventional prevention trial for Japanese Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ChimeriVax™-JE

JE-VAX®

Arm Description

Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.

Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

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).

Full Information

NCT ID

NCT00314145

First Posted

April 11, 2006

Last Updated

December 4, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00314145

Brief Title

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

Official Title

A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

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 ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain 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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

820 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ChimeriVax™-JE

Arm Type

Experimental

Arm Description

Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.

Arm Title

JE-VAX®

Arm Type

Active Comparator

Arm Description

Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.

Intervention Type

Biological

Intervention Name(s)

ChimeriVax™-JE

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

JE-VAX®

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination

Description

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

Title

Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®

Description

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 Outcome Measure Information:

Title

Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination

Description

Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).

Time Frame

Up to Day 60 post-first vaccination

Title

Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination

Description

Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).

Time Frame

Day 60 post-first vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Angles, M.D.

Organizational Affiliation

Heart of America Research Institute

Official's Role

Principal Investigator

Facility Information:

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60610

Country

United States

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98403

Country

United States

City

Adelaide

Country

Australia

City

Melbourne

Country

Australia

City

New South Wales

Country

Australia

City

Queensland

Country

Australia

City

Victoria

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

20934459

Citation

Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.

Results Reference

derived

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