A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
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ClinicalTrials.gov Identifier: NCT00319592 |
Recruitment Status :
Completed
First Posted : April 27, 2006
Results First Posted : August 16, 2012
Last Update Posted : August 20, 2012
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Condition or disease | Intervention/treatment | Phase |
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Japanese Encephalitis | Biological: ChimeriVax™-JE vaccine Biological: JE-VAX® vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | May 2005 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
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Experimental: ChimeriVax™-JE
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
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Biological: ChimeriVax™-JE vaccine
0.5 mL, subcutaneously
Other Name: ChimeriVax™-JE |
Active Comparator: JE-VAX®
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
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Biological: JE-VAX® vaccine
1.0 mL, subcutaneously
Other Name: JE-VAX® |
- 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 [ Time Frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination ]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 [ Time Frame: Day 0 up to Day 56 post-vaccination ]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. [ Time Frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose ]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® [ Time Frame: Day 0 (pre-vaccination) up to month 12 post-vaccination ]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® [ Time Frame: Day 0 up to Day 6 post-vaccination ]Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

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Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319592
United States, Kansas | |
Clinical Pharamacology Center | |
Lenexa, Kansas, United States, 66219 |
Principal Investigator: | Nancy L Abdou, MD | PRA Health Sciences |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00319592 |
Other Study ID Numbers: |
H-040-008 |
First Posted: | April 27, 2006 Key Record Dates |
Results First Posted: | August 16, 2012 |
Last Update Posted: | August 20, 2012 |
Last Verified: | August 2012 |
Japanese encephalitis ChimeriVax™-JE JE-VAX® |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infections |
Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |