Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: IC51

• Registration Number: NCT00595790
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged \> or = 18 years

Detailed Description

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-02
• Study Completion: 2007-11
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-16
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2014-02-07
• Results First Posted: 2014-03-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• At least 18 years of age
• Written informed consent obtained prior to study entry

Exclusion Criteria

• History of clinical manifestation of any flavivirus infection
• History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
• A family history of congenital or hereditary immunodeficiency
• History of autoimmune disease
• Any acute infections within 4 weeks prior to enrollment
• Infection with HIV, Hepatitis B or Hepatitis C
• Pregnancy, lactation or unreliable contraception in female subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC51 2 x 6 mcg	IC51	2 x 6 mcg (microgram)
IC51 1 x 12 mcg	IC51	1 x 12 mcg (microgram)
IC51 1 x 6 mcg	IC51	1 x 6 mcg (microgram)

Primary Outcome Measures

Name	Time	Method
SCR (Seroconversion Rate) at Day 56	day 56	Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer

Secondary Outcome Measures

Name	Time	Method
SCR at Day 10, 28 and 35	Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56	Day 10, 28, 35 and 56
Safety	Study duration	AEs, Local and systemic tolerability, Safety laboratory parameters