Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Japanese Encephalitis Clinical Trial

Official title:

Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01559831
• Other study ID #: IC51-319
• Status: Withdrawn
• Phase: Phase 1
• First received: March 19, 2012
• Last updated: March 7, 2013
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IXIARO
Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

Locations

Country	Name	City	State
United Kingdom	UCLH Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate (SCR) at Day 28		at Day 28	No
Secondary	SCR at Day 0		Day 0	No
Secondary	Geometric Mean Titer at Day 0 and 28		Day 0 and Day 28	No
Secondary	Rate of Adverse Events up to Day 28		Day 28	Yes