Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: IXIARO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IXIARO<br>IXIARO, applied according to licensed dose, intramuscular | Biological: IXIARO<br>* Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate (SCR) at Day 28 |  | at Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCR at Day 0 |  | Day 0 | 
| Geometric Mean Titer at Day 0 and 28 |  | Day 0 and Day 28 | 
| Rate of Adverse Events up to Day 28 |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japanese Encephalitis, IXIARO, Japanese Encephalitis Vaccine