Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj (BR-JELITE)

A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC

A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Biological: Japanese encephalitis vaccine

Detailed Description

This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Hospital
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of
      • Wonju Sevrance Christian Hospital
  • GyeongGi-Do
    • Goyang, GyeongGi-Do, Korea, Republic of
      • Inje University Ilsan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
• Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
• Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
• Male and female children who are identified to be healthy based on physical examination and medical history.

Exclusion Criteria:

• Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
• Children who have moderate or severe acute disease (regardless of fever).
• Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
• Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
• Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.
• Children who have shown anaphylactic reaction to the investigational products administered in the KD287-BR-CT-301study or who are likely to be allergic to the ingredients of the investigational product.
• Children who have been diagnosed with immunodeficiency such as acquired immune deficiency or who have family history of immunodeficiency.
• Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.
• Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.
• There is a possibility that immune globulin preparations has not been excreted enough on the day of booster dosing of JEV if children have received such a product.
• Children who are currently participating or planning to participate in other clinical stud-ies during the study period.
• Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Japanese encephalitis vaccine; After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC	Biological: Japanese encephalitis vaccine; Dosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm.; Other Names: Boryung Cell-Culture Japanese Encephalitis Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the seroconversion rates before and after the fourth dose of JEV	Day 28 (28 days after booster dose)]

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the seropositive rates before and after the fourth dose of JEV	Day 28 (28 days after booster dose)]
To assess the geometric mean titer (GMT) before and after the fourth dose of JEV	Day 28 (28 days after booster dose)]
To assess the percentage of subjects who develop neutralizing antibody titers	Day 28 (28 days after booster dose)
To assess the percentage of subjects in their neutralizing anti-body titers	Day 28 (28 days after booster dose)

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Study Director: HJ Jung, MD, Boryung Pharmaceutical Company

Publications and helpful links

General Publications

• Yun KW, Lee HJ, Park JY, Cho HK, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine. 2018 Mar 7;36(11):1398-1404. doi: 10.1016/j.vaccine.2018.01.075.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BR-KD-287-CT-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No