Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- Registration Number
- NCT00595309
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
Inclusion Criteria
- Healthy adults who completed the primary immunization in study IC51 309
- Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test
Main
Exclusion Criteria
• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Seroconversion Rate at Month 12 after booster
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer D28, Month 6 and Month 12 after booster Safety and Adverse Events up to Month 12 after booster Seroconversion at D28 and Month 6 after booster
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which IC51 induces long-term immunogenicity against Japanese Encephalitis virus (JEV)?
How does the booster dose of IC51 compare to standard Japanese Encephalitis vaccines in terms of antibody persistence and efficacy?
Are there specific biomarkers associated with enhanced immune response following IC51 booster vaccination in phase 3 trials?
What adverse events were reported in the NCT00595309 trial and how were they managed in the context of Valneva's vaccine development?
What are the current landscape and competitive alternatives to IC51 for Japanese Encephalitis prevention in endemic regions?
Trial Locations
- Locations (3)
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
🇦🇹Vienna, Austria
Zentrum für Reisemedizin, Dependance für klinische Studien
🇦🇹Vienna, Austria
Berliner Zentrum Reise- und Tropenmedizin
🇩🇪Berlin, Germany
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie🇦🇹Vienna, Austria