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Also known as ChimeriVax™-JE
ChimeriVax-JE vaccine · 4 trials · 2 indications
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.
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
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. |
| Placebo | PLACEBO_COMPARATOR | All subjects received a single injection of placebo on Day 0. |
| ChimeriVax™ JE 4 log10 PFU Vaccine | EXPERIMENTAL | All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
| 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) |
| ChimeriVax-JE, Japanese Encephalitis vaccine | BIOLOGICAL | 0.5 mL, Subcutaneous |
| 0.9% Saline | BIOLOGICAL | 0.5 mL, Subcutaneous |
| 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 used to prevent Japanese encephalitis, a viral infection of the brain. It is being developed for active immunization against Japanese encephalitis virus in adults and children. The clinical program enrolled healthy volunteers in studies conducted in the United States, Australia, and India.
ChimeriVax-JE vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical development program for this Japanese encephalitis vaccine candidate.
ChimeriVax-JE vaccine is in Phase 3 clinical development. It is an investigational vaccine and is not approved for commercial use. The program includes completed Phase 2 and Phase 3 trials, with no trials currently active.
ChimeriVax-JE vaccine has been studied in completed trials including NCT00314145, a Phase 3 safety and efficacy study of 820 adults in the United States and Australia, and NCT00314132, a Phase 3 safety study of 2,004 adults. Phase 2 trials NCT00441259 and NCT00319592 evaluated the vaccine in children in India and adults in the United States.
ChimeriVax-JE vaccine is also known as ChimeriVax-JE, ChimeriVax-JE, and Japanese Encephalitis vaccine. These names refer to the same Sanofi vaccine candidate developed to prevent Japanese encephalitis.
ChimeriVax-JE vaccine was evaluated in randomized, double-blind, placebo-controlled trials. The completed studies enrolled a total of 2,004 participants, including healthy adults aged 18 and older and children as young as 9 months, across sites in the United States, Australia, and India.