Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

NCT00735644 | Completed Phase 3 Results DMC

• 1 other identifier: JEC02
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 8

Brief Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects

Conditions

Japanese Encephalitis; Hepatitis A

Keywords

Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots

  Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Secondary Outcomes (4)

• Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.

  Day 0 up to Day 14 post-vaccination

Other Outcomes (1)

• Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.

  Day 0 (pre-vaccination)

Study Arms (5)

JE-CV GPO MBP (Lot 1)

EXPERIMENTAL

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.

Biological: Japanese encephalitis vaccine

JE-CV GPO MBP (Lot 2)

EXPERIMENTAL

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.

Biological: Japanese encephalitis vaccine

JE-CV GPO MBP (Lot 3)

EXPERIMENTAL

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.

Biological: Japanese encephalitis vaccine

JE-CV WRAIR (Group 4)

ACTIVE COMPARATOR

Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)

Biological: Japanese encephalitis vaccine (Acambis)

Hepatitis A (Group 5)

SHAM COMPARATOR

Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine

Biological: Hepatitis A vaccine

Interventions

Japanese encephalitis vaccine BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: ChimeriVax™-JE

JE-CV GPO MBP (Lot 1)

Japanese encephalitis vaccine (Acambis) BIOLOGICAL

0.5 mL, Subcutaneous

JE-CV WRAIR (Group 4)

Hepatitis A vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Avaxim® 80U Pediatric

Hepatitis A (Group 5)

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• In good general health, without significant medical history.
• Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
• Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
• Completion of vaccinations according to the national immunization schedule.

You may not qualify if:

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
• Administration of any anti-viral within 2 months preceding V01.
• History of central nervous system disorder or disease, including seizures.
• Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
• Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
• Receipt of any JE vaccine or hepatitis A vaccine.
• Previous vaccination against flavivirus disease.
• History of flavivirus infection (confirmed either clinically, serologically or microbiologically)

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Unknown Facility

Alabang, Philippines

Location

Unknown Facility

Bayanan, Philippines

Location

Unknown Facility

Buli, Philippines

Location

Unknown Facility

Cupang, Philippines

Location

Unknown Facility

Sucat, Philippines

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Khon Kaen, 40002, Thailand

Location

Related Publications (2)

• Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.

  PMID: 22777096 RESULT

• Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.

  PMID: 24656175 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Encephalitis, Japanese; Hepatitis A

Interventions

Japanese Encephalitis Vaccines; Hepatitis A Vaccines

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; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  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 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 21, 2015
• Results First Posted: August 15, 2014

Record last verified: 2015-04

Locations

TH (3); PH (5)