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Also known as ChimeriVax™-JE
Live attenuated Japanese encephalitis virus · 2 trials · 2 indications
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.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
| 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. |
| Study Group 1: ChimeriVax™-JE Vaccine first, then Placebo | EXPERIMENTAL | Participants received ChimeriVax™-JE on Day 0 and ChimeriVax diluent on Day 28 |
| Study Group 2: Placebo first, then ChimeriVax™-JE Vaccine | EXPERIMENTAL | Participants received ChimeriVax diluent on Day 0 and ChimeriVax™-JE on Day 28. |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis virus | BIOLOGICAL | 0.5 mL,Subcutaneous |
| ChimeriVax™ diluent (Placebo) | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Live attenuated Japanese encephalitis virus, then ChimeriVax diluent | BIOLOGICAL | ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28 |
| ChimeriVax diluent, then Live attenuated Japanese encephalitis virus | BIOLOGICAL | ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28. |
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 candidate being developed by Sanofi for the prevention of Japanese encephalitis, a viral infection of the brain. It is designed to stimulate an immune response using a weakened form of the virus. It is in Phase 2 clinical development.
Live attenuated Japanese encephalitis virus is being studied for the prevention of Japanese encephalitis, a mosquito-borne viral disease that can cause encephalitis, or inflammation of the brain. The clinical program has enrolled healthy adult volunteers in Australia to evaluate the vaccine candidate.
Sanofi, which trades on the New York Stock Exchange under the ticker SNY, is the developer of Live attenuated Japanese encephalitis virus. The company has sponsored the Phase 2 clinical studies of the vaccine candidate in Australia.
Live attenuated Japanese encephalitis virus is in Phase 2 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. The completed Phase 2 trials were conducted in Australia in healthy adults aged 18 years and older.
Two completed Phase 2 trials have evaluated Live attenuated Japanese encephalitis virus: NCT00981630, titled Study of Live Attenuated ChimeriVax-Japanese Encephalitis Vaccine, which enrolled 128 participants, and NCT00981175, titled A Study of ChimeriVax-JE Live Attenuated Vaccine in Healthy Adults, which enrolled 202 participants. Both were conducted in Australia.
Yes, Live attenuated Japanese encephalitis virus is also known as ChimeriVax diluent. The ChimeriVax name appears in the trial titles for the Phase 2 studies, including ChimeriVax-Japanese Encephalitis Vaccine and ChimeriVax-JE Live Attenuated Vaccine, so searches using either name refer to the same Sanofi vaccine candidate.