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

Phase 4

Completed

• Conditions: Encephalitis
• Interventions: Biological: Live attenuated chimeric Japanese Encephalitis vaccine; Biological: Inactivated Hepatitis A vaccine

• Registration Number: NCT02526550
• Lead Sponsor: Siriraj Hospital

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.

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2015-08-09
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Results First Submitted: 2016-01-12
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Results First Posted: 2016-12-07
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imojev	Live attenuated chimeric Japanese Encephalitis vaccine	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
Imojev	Inactivated Hepatitis A vaccine	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination	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

Name	Time	Method
Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination	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.
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™	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.