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ChimeriVax-JE vaccine · 3 trials · 1 indication
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. \[Seropositive status can be 'Yes' or 'No'\]
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE | EXPERIMENTAL | Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms. |
| JE-VAX® | ACTIVE_COMPARATOR | Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30. |
| JE-CV Group | EXPERIMENTAL | Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV) |
| MBDV Group | ACTIVE_COMPARATOR | Participants will receive the mouse brain-derived vaccine (MBDV) |
| Name | Type | Description |
|---|---|---|
| ChimeriVax™-JE | BIOLOGICAL | 0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline) |
| JE-VAX® | BIOLOGICAL | 0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) |
| Japanese Encephalitis Inactivated Mouse Brain Vaccine | BIOLOGICAL | Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously |
| ChimeriVax™-JE vaccine | BIOLOGICAL | 0.5 mL, subcutaneously |
| JE-VAX® vaccine | BIOLOGICAL | 1.0 mL, subcutaneously |
Inclusion Criteria: * Subjects aged 18 or above * Subjects in good general health. * Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: * History of vaccination/infection with JE or Yellow fever or other flaviviruses * History of residence/tr...
ChimeriVax-JE vaccine is an investigational vaccine being developed for the prevention of Japanese Encephalitis, a viral infection that can cause encephalitis. It is designed for use in adults and children, with clinical trials conducted in the United States, Australia, and India.
ChimeriVax-JE vaccine is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The vaccine is currently in clinical development and has not been approved for commercial use.
ChimeriVax-JE vaccine has completed Phase 3 clinical trials, which are the final stage of testing before seeking regulatory approval. However, it remains an investigational product and is not yet approved by regulatory authorities such as the FDA.
ChimeriVax-JE vaccine has completed three clinical trials: NCT00314132, a Phase 3 safety study with 2004 participants; NCT00314145, a Phase 3 safety and efficacy study with 820 participants; and NCT00319592, a Phase 2 study with 60 participants. All trials enrolled healthy adults aged 18 years and older.
ChimeriVax-JE vaccine is not the same as JE-VAX. Clinical trials NCT00314145 and NCT00319592 directly compared ChimeriVax-JE vaccine to JE-VAX, an inactivated mouse brain-derived Japanese Encephalitis vaccine, to evaluate their relative safety and efficacy.