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

Siriraj Hospital

Status and phase: Completed; Phase 4

Conditions: Encephalitis

Treatments: Biological: Live attenuated chimeric Japanese Encephalitis vaccine; Biological: Inactivated Hepatitis A vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02526550

JEC26-EXT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Imojev

Experimental group

Description:

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

Treatment:

Biological: Inactivated Hepatitis A vaccine

Biological: Live attenuated chimeric Japanese Encephalitis vaccine