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Live attenuated Japanese encephalitis virus · 1 trial · 1 indication
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE Dose Level 1 | EXPERIMENTAL | Participants received ChimeriVax™-JE (Japanese Encephalitis) a dose of 3.0 log10 Plaque-forming units (PFU) on Day 0. |
| ChimeriVax™-JE Dose Level 2 | EXPERIMENTAL | Participants received ChimeriVax™-JE a dose of 4.0 log10 PFU on Day 0. |
| ChimeriVax™-JE Dose Level 3 | EXPERIMENTAL | Participants received ChimeriVax™-JE a dose of 5.0 log10 PFU on Day 0. |
| Placebo | PLACEBO_COMPARATOR | Participants received ChimeriVax diluent, 0.5 mL on Day 0. |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis virus | BIOLOGICAL | 0.5 mL,Subcutaneous |
| ChimeriVax™ diluent (Placebo) | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria : * All aspects of the protocol explained and written informed consent obtained from the participant. * Aged ≥18 to \< 49 years. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results. * ...
Live attenuated Japanese encephalitis virus is an investigational vaccine being studied for the prevention of Japanese Encephalitis, a viral infection of the brain transmitted by mosquitoes. It is currently in Phase 2 clinical development and is not yet approved for use.
Live attenuated Japanese encephalitis virus is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing Japanese Encephalitis.
Live attenuated Japanese encephalitis virus is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 2 trial has been completed, and the vaccine remains under study for the prevention of Japanese Encephalitis.
Live attenuated Japanese encephalitis virus has been studied in one completed Phase 2 clinical trial, identified as NCT00981630. This trial, titled 'Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine,' enrolled 128 participants in Australia and evaluated the vaccine in healthy adults aged 18 years and older.
Live attenuated Japanese encephalitis virus is also known as ChimeriVax™-Japanese Encephalitis Vaccine, as referenced in the clinical trial title. This alternative name is used in the context of the Phase 2 study conducted by Sanofi to evaluate the vaccine for the prevention of Japanese Encephalitis.