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Also known as IMOJEV
JE-CV Vaccine · 2 trials · 2 indications
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50 test.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50.
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus \<10 (1/dilution) and titers against the 4 dengue serotypes \<10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
| Arm | Type | Description |
|---|---|---|
| IMOJEV Group | EXPERIMENTAL | Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study. |
| Group 1: JE-CV Vaccine Booster | EXPERIMENTAL | Participants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0. |
| Group 2: JE-CV Vaccine First Dose | EXPERIMENTAL | JE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0. |
| Group 3: Varicella Vaccine | ACTIVE_COMPARATOR | JE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0. |
| Name | Type | Description |
|---|---|---|
| IMOJEV | BIOLOGICAL | 0.5 mL, Subcutaneous |
| JE-CV Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
| Varicella Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
Inclusion Criteria: * Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination * Age 2 to 4 years on the day of inclusion * In good general health at the time of inclusion * Informed Concent Form signed and dated by parent(s) or another legal...
The JE-CV Vaccine is an investigational vaccine developed by Sanofi for the prevention of Japanese Encephalitis, a viral infection of the brain. It is a chimeric virus vaccine currently in Phase 3 clinical development. It is not yet approved and remains under study in pediatric populations.
The JE-CV Vaccine is being developed for protection against Japanese Encephalitis, a mosquito-borne viral disease. Its clinical program has studied the vaccine in children, including those previously immunized with JE-CV. The vaccine is investigational and has not been approved for use.
The JE-CV Vaccine is developed by Sanofi, the French multinational pharmaceutical company whose shares trade on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the vaccine in Japanese Encephalitis.
The JE-CV Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulatory authority based on the available program information.
The JE-CV Vaccine has been evaluated in one completed Phase 3 trial, NCT01190228, titled a study of Japanese Encephalitis Chimeric Virus Vaccine in children previously immunized with JE-CV. The trial enrolled 454 participants in the Philippines, was randomized and active-controlled, and included healthy volunteers aged 36 months and older.
The JE-CV Vaccine is a chimeric virus vaccine, a modality that uses a live attenuated virus backbone carrying Japanese Encephalitis virus genes to stimulate protective immunity. This design aims to generate an immune response against Japanese Encephalitis without causing the disease. It is administered as a preventive vaccine rather than a treatment.