Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

NCT00621764 | Completed Phase 2 Results DMC

• 1 other identifier: JEC01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.

Conditions

Japanese Encephalitis; Hepatitis A

Keywords

Japanese encephalitis (JE); Hepatitis A; Inactivated Mouse-Brain

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection

  12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.

  Day 0 up to Day 14 post-vaccination

• Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection

  12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.

  Day 0 up to Day 14 post-vaccination

Secondary Outcomes (2)

• Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination

  Day 0 (pre-vaccination) and Day 28 after final vaccination

• Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination

  Day 0 (pre-vaccination) and Day 28 after final vaccination

Other Outcomes (2)

• Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination

  Day 0 (pre-vaccination) up to 5 years after final vaccination

• Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine

  Day 0 (pre-vaccination) up to 5 years after final vaccination

Study Arms (4)

JE-CV/Hepatitis A (Group 1)

EXPERIMENTAL

Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Hepatitis A/JE-CV (Group 2)

EXPERIMENTAL

Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

JE-CV/Hepatitis A (Group 3)

EXPERIMENTAL

Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Hepatitis A/JE-CV (Group 4)

EXPERIMENTAL

Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Interventions

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) BIOLOGICAL

≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)

Also known as: ChimeriVax™-JE

JE-CV/Hepatitis A (Group 1)

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) BIOLOGICAL

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Also known as: ChimeriVax™-JE

Hepatitis A/JE-CV (Group 2)

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
• Completion of vaccinations according to the national immunization schedule
• Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

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 first trial vaccination.
• 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 the trial vaccine or 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.
• Receipt of hepatitis A vaccine.
• History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
• Administration of any anti-viral within 2 months preceding the screening visit.
• History of central nervous system disorder or disease.
• Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
• Planned participation in another clinical trial during the present trial period.
• 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, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
• Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Related Publications (3)

• Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, Gailhardou S, Boaz M, Feroldi E. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):1111-7. doi: 10.1097/INF.0b013e3181f68e9c.

  PMID: 20856164 RESULT

• Feroldi E, Boaz M, Yoksan S, Chokephaibulkit K, Thisyakorn U, Pancharoen C, Monfredo C, Bouckenooghe A. Persistence of Wild-Type Japanese Encephalitis Virus Strains Cross-Neutralization 5 Years After JE-CV Immunization. J Infect Dis. 2017 Jan 15;215(2):221-227. doi: 10.1093/infdis/jiw533.

  PMID: 27815383 DERIVED

• Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Pancharoen C, Boaz M, Bouckenooghe A, Feroldi E. Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine. 2016 Nov 4;34(46):5664-5669. doi: 10.1016/j.vaccine.2016.09.018. Epub 2016 Sep 27.

  PMID: 27686833 DERIVED

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 Director

  Sanofi Pasteur SA

  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: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2013
• Last Updated: October 2, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

TH (3)