Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

NCT00981630 | Completed Phase 2 Results DMC

• 1 other identifier: H-040-007
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo. Primary Objectives: Safety:

• To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old). Immunogenicity:
• To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity.
• To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis; ChimeriVax™-JE Vaccine; Adult

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo

  Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.

  Day 11 and Day 30 post-vaccination

• Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo

  Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.

  Day 30 post-vaccination

• Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo

  Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.

  Day 0 (post-vaccination) up to Day 30 post-vaccination

Secondary Outcomes (3)

• Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo

  Day 11 and Day 30 post-vaccination

• Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo

  Day 30 post-vaccination

• Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo

  Day 30 up to 12 months post-vaccination

Study Arms (4)

ChimeriVax™-JE Dose Level 1

EXPERIMENTAL

Participants received ChimeriVax™-JE (Japanese Encephalitis) a dose of 3.0 log10 Plaque-forming units (PFU) on Day 0.

Biological: Live attenuated Japanese encephalitis virus

ChimeriVax™-JE Dose Level 2

EXPERIMENTAL

Participants received ChimeriVax™-JE a dose of 4.0 log10 PFU on Day 0.

Biological: Live attenuated Japanese encephalitis virus

ChimeriVax™-JE Dose Level 3

EXPERIMENTAL

Participants received ChimeriVax™-JE a dose of 5.0 log10 PFU on Day 0.

Biological: Live attenuated Japanese encephalitis virus

Placebo

PLACEBO COMPARATOR

Participants received ChimeriVax diluent, 0.5 mL on Day 0.

Biological: ChimeriVax™ diluent (Placebo)

Interventions

Live attenuated Japanese encephalitis virus BIOLOGICAL

0.5 mL,Subcutaneous

Also known as: ChimeriVax™-JE

ChimeriVax™-JE Dose Level 1

ChimeriVax™ diluent (Placebo) BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Paricipants received a dose of ChimeriVax™ diluent at Day 0.

Placebo

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All aspects of the protocol explained and written informed consent obtained from the participant.
• Aged ≥18 to \< 49 years.
• In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
• Participant must be available for the study duration, including all planned follow-up visits.
• Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate.
• For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal \[at least one year since last menstrual period\]).

You may not qualify if:

• A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject).
• Previous or current military service.
• History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more.
• Known or suspected immunodeficiency (e.g., human immunodeficiency virus \[HIV\] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids \> 10 mg prednisone, or equivalent, in the last three months or during the trial (up to Day 30).
• History of thymoma, thymic surgery (removal) or myasthenia gravis.
• Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe criteria described in the toxicity gradings for laboratory values).
• 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 (these subjects will be rescheduled for vaccination at a later date).
• Physical examination indicating any clinically significant medical condition.
• Body temperature \> 38.1°C (100.6°F) or acute illness within 3 days prior to inoculation (participant may be rescheduled).
• Intention to travel out of the area prior to the study visit on Day 30.
• Seropositive to hepatitis C virus or HIV or positive for Hepatitis B Surface Antigen.
• Lactation or intended pregnancy in female subjects.
• Excessive alcohol consumption, drug abuse, significant psychiatric illness.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Unknown Facility

Herston, Queensland, QLD 4006, Australia

Location

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

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; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 21, 2009
• First Posted: September 22, 2009
• Study Start: November 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: November 1, 2007
• Last Updated: December 5, 2012
• Results First Posted: December 5, 2012

Record last verified: 2012-11

Locations

AU (2)