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

Primary Purpose

Japanese Encephalitis, Hepatitis A

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis (JE), Hepatitis A, Inactivated Mouse-Brain

Eligibility Criteria

12 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

JE-CV/Hepatitis A (Group 1)

Hepatitis A/JE-CV (Group 2)

JE-CV/Hepatitis A (Group 3)

Hepatitis A/JE-CV (Group 4)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV 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.
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.

Full Information

First Posted
February 12, 2008
Last Updated
September 23, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00621764
Brief Title
Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Official Title
A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis, Hepatitis A
Keywords
Japanese encephalitis (JE), Hepatitis A, Inactivated Mouse-Brain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JE-CV/Hepatitis A (Group 1)
Arm Type
Experimental
Arm Description
Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
Arm Title
Hepatitis A/JE-CV (Group 2)
Arm Type
Experimental
Arm Description
Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)
Arm Title
JE-CV/Hepatitis A (Group 3)
Arm Type
Experimental
Arm Description
Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
Arm Title
Hepatitis A/JE-CV (Group 4)
Arm Type
Experimental
Arm Description
Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)
Intervention Type
Biological
Intervention Name(s)
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Other Intervention Name(s)
ChimeriVax™-JE
Intervention Description
≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Other Intervention Name(s)
ChimeriVax™-JE
Intervention Description
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Intervention Type
Biological
Intervention Name(s)
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Other Intervention Name(s)
ChimeriVax™-JE
Intervention Description
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Other Intervention Name(s)
ChimeriVax™-JE
Intervention Description
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Primary Outcome Measure Information:
Title
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
Description
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.
Time Frame
Day 0 up to Day 14 post-vaccination
Title
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
Description
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.
Time Frame
Day 0 up to Day 14 post-vaccination
Secondary Outcome Measure Information:
Title
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
Description
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.
Time Frame
Day 0 (pre-vaccination) and Day 28 after final vaccination
Title
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
Description
JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame
Day 0 (pre-vaccination) and Day 28 after final vaccination
Other Pre-specified Outcome Measures:
Title
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination
Description
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame
Day 0 (pre-vaccination) up to 5 years after final vaccination
Title
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine
Description
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame
Day 0 (pre-vaccination) up to 5 years after final vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20856164
Citation
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.
Results Reference
result
PubMed Identifier
27815383
Citation
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.
Results Reference
derived
PubMed Identifier
27686833
Citation
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.
Results Reference
derived

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

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