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

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ClinicalTrials.gov Identifier: NCT00621764
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : September 25, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.


Condition or disease Intervention/treatment Phase
Japanese Encephalitis Hepatitis A Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) Phase 2

Detailed Description:
This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: JE-CV/Hepatitis A (Group 1)
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)
≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
Other Name: ChimeriVax™-JE
Experimental: Hepatitis A/JE-CV (Group 2)
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)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Name: ChimeriVax™-JE
Experimental: JE-CV/Hepatitis A (Group 3)
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)
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
Other Name: ChimeriVax™-JE
Experimental: Hepatitis A/JE-CV (Group 4)
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)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Name: ChimeriVax™-JE


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection [ Time Frame: Day 0 up to Day 14 post-vaccination ]

    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.


  2. Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection [ Time Frame: Day 0 up to Day 14 post-vaccination ]

    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.



Secondary Outcome Measures :
  1. Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ]
    JE virus neutralizing antibody measurement was assessed by 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.

  2. Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ]
    JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.


Other Outcome Measures:
  1. Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination [ Time Frame: Day 0 (pre-vaccination) up to 5 years after final vaccination ]
    Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.

  2. Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine [ Time Frame: Day 0 (pre-vaccination) up to 5 years after final vaccination ]
    Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
  • Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

Exclusion Criteria:

  • 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.
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
  • 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.
  • Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
  • History of seizures.
  • Previous vaccination against flavivirus disease.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00621764


Locations
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Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00621764    
Other Study ID Numbers: JEC01
First Posted: February 22, 2008    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Japanese encephalitis (JE)
Hepatitis A
Inactivated Mouse-Brain
Additional relevant MeSH terms:
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Hepatitis A
Encephalitis, Japanese
Hepatitis
Encephalitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
Central Nervous System Viral Diseases
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs