Safety and effectiveness of boosting healthy adults with new cell-culture-derived JE vaccine (JESPECT), where mouse-brain-derived vaccine (JEVAX) has previously been administered.

Not Applicable

Completed

• Conditions: Japanese encephalitis; Infection - Other infectious diseases; Public Health - Other public health; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12611001090909
• Lead Sponsor: Csongor Oltvolgyi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) Previous MBDV vaccinee, due for boosting (3-5 years post last dose).
2) Volunteer in 'short-notice-to-move' military unit which requires currency with JE vaccination.

Exclusion Criteria

1) Pregnancy
2) Lactation
3) Administration of any vaccine 30 days prior to VCDV administration
4) Serious ADR to a previous vaccine
5) Acute febrile illness
6) Known or suspected immune deficiency

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability of VCDV in prior MBDV recipients. This is assessed via questionairre addressing local and systemic effects at the time of the second VCDV dose, and by medical chart audit at 14 days post second dose.[Up to 14 days post second dose of VCDV.];JE immunogenicity, as measured by PRNT50.[28 days post first dose of VCDV. Baseline immunogenicity is also assessed on serum taken at day 0.]

Secondary Outcome Measures

Name	Time	Method
il[Nil]