Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

NCT00314132 | Completed Phase 3 Results

• 1 other identifier: H-040-010
• Study Type: interventional
• Target: 2,004
• Locations: 2 countries
• Sites: 22

Brief Summary

The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.

Conditions

Encephalitis; Japanese Encephalitis

Keywords

Japanese Encephalitis; Encephalitis virus; ChimeriVax™-JE Vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo

  Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.

  Day 0 up to 30 days post-vaccination

• Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo

  Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.

  Day 0 up to 30 days post-vaccination

Study Arms (2)

Placebo

PLACEBO COMPARATOR

All subjects received a single injection of placebo on Day 0.

Biological: 0.9% Saline

ChimeriVax™ JE 4 log10 PFU Vaccine

EXPERIMENTAL

All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.

Biological: ChimeriVax-JE, Japanese Encephalitis vaccine

Interventions

ChimeriVax-JE, Japanese Encephalitis vaccine BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: ChimeriVax™

ChimeriVax™ JE 4 log10 PFU Vaccine

0.9% Saline BIOLOGICAL

0.5 mL, Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained from the subject.
• Aged 18 years or above at screening.
• In good general health
• Subject available for the study duration
• For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.

You may not qualify if:

• A history of vaccination against or infection with JE.
• Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
• History of thymoma, thymic surgery (removal) or myasthenia gravis.
• Clinically significant abnormalities on laboratory assessment
• Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
• Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
• Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
• Physical examination indicating any clinically significant medical condition.
• Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation.
• Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
• Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
• Lactation or intended pregnancy in female subjects.
• Excessive alcohol consumption, drug abuse, significant psychiatric illness.
• A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
• Participation in another clinical study within 30 days of the screening visit for this study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (22)

Unknown Facility

Burbank, California, 92505, United States

Location

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Costa Mesa, California, 92708, United States

Location

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Davis, California, 95616, United States

Location

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San Francisco, California, 94102, United States

Location

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Vallejo, California, 94589, United States

Location

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Miami, Florida, 33173, United States

Location

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Orlando, Florida, 32809, United States

Location

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Pembroke Pines, Florida, 33024, United States

Location

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Iowa City, Iowa, 52242, United States

Location

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Overland Park, Kansas, 66212, United States

Location

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Bardstown, Kentucky, 40004, United States

Location

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Livonia, Michigan, 48152, United States

Location

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Sprnigfield, Missouri, 65802, United States

Location

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Omaha, Nebraska, 68134, United States

Location

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Winston-Salem, North Carolina, 27109, United States

Location

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Fort Worth, Texas, 76135, United States

Location

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Darlinghurst, NSW 2010, Australia

Location

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Enoggera, QLD 4051, Australia

Location

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Heidelbeg West, VIC 3081, Australia

Location

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Kippa-Ring, QLD 4021, Australia

Location

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Mill Park, VIC 3082, Australia

Location

Unknown Facility

Toorak Gardens, SA 5056, Australia

Location

Related Publications (1)

• 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.

  PMID: 20934459 DERIVED

MeSH Terms

Conditions

Encephalitis; Encephalitis, Japanese

Interventions

Japanese Encephalitis Vaccines; ChimeriVax; Saline Solution

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Steven G Hull, MD

  Vince and Associates Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: October 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 6, 2012
• Results First Posted: December 5, 2012

Record last verified: 2012-12

Locations

AU (6); US (16)