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Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

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ClinicalTrials.gov Identifier: NCT02526550
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Kulkanya Chokephaibulkit, Siriraj Hospital

Study Description
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Brief Summary:
This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

Condition or disease Intervention/treatment Phase
Encephalitis Biological: Live attenuated chimeric Japanese Encephalitis vaccine Biological: Inactivated Hepatitis A vaccine Phase 4

Detailed Description:
The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children
Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Imojev
Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
 Biological: Live attenuated chimeric Japanese Encephalitis vaccine
0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Other Name: Imojev

Biological: Inactivated Hepatitis A vaccine
0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Other Name: Havrix


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination [ Time Frame: Day 0 (Baseline) and Day 28 (post-vaccination) ]
    Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).


Secondary Outcome Measures :
  1. Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination [ Time Frame: Day 0 (Baseline) and Day 28 (post-vaccination) ]
    Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.

  2. Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ [ Time Frame: Up to 28 days post booster vaccination ]
    Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 1 to <5 years on the day of inclusion
  • History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
  • In good general health at the time of inclusion
  • Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

  • Receipt of blood or blood products in the past 3 months
  • Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
  • Previous receipt of 2 doses of any vaccine against JE virus
  • Known hypersensitivity to any of the vaccine components
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
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): NCT02526550


Sponsors and Collaborators
Siriraj Hospital
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Kulkanya Chokephaibulkit, Professor Siriraj Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kulkanya Chokephaibulkit, Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT02526550    
Other Study ID Numbers: JEC26-EXT
First Posted: August 18, 2015    Key Record Dates
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The submission of study review and results to a peer-review journal is ongoing.
Keywords provided by Kulkanya Chokephaibulkit, Siriraj Hospital:
Live attenuated Japanese Encephalitis vaccine
IMOJEV
CD.JEVAX
Booster
Thai children
 Immunogenicity
Safety
Interchangeability
Hepatitis A vaccine
Vaccination or Other Immunization Procedure
Additional relevant MeSH terms:
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Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs