Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Phase 1

Withdrawn

• Conditions: Japanese Encephalitis
• Interventions: Biological: IXIARO

• Registration Number: NCT01559831
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

Detailed Description

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Study Start: 2012-06
• Primary Completion: 2012-12
• Status Verified: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
• In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
• Written informed consent obtained from the subject prior to any study-related procedures

Exclusion Criteria

• Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
• Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
• Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
• Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
• Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
• Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
• Persons who are committed to an institution
• At Day 0, upcoming scheduled travel to a JE endemic region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IXIARO	IXIARO	IXIARO, applied according to licensed dose, intramuscular

Primary Outcome Measures

Name	Time	Method
Seroconversion rate (SCR) at Day 28	at Day 28

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse Events up to Day 28	Day 28
SCR at Day 0	Day 0
Geometric Mean Titer at Day 0 and 28	Day 0 and Day 28

Trial Locations

Locations (1)

UCLH Foundation Trust; 🇬🇧 London, United Kingdom