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Also known as ChimeriVax-JE, STAMARIL®
Live attenuated Japanese encephalitis virus; Yellow fever virus · 1 trial · 2 indications
Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.
Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE then STAMARIL® | EXPERIMENTAL | Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30 |
| STAMARIL® then ChimeriVax™-JE | EXPERIMENTAL | Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30 |
| ChimeriVax™-JE and STAMARIL®, then Diluent | EXPERIMENTAL | Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30. |
| Diluent then ChimeriVax™-JE and STAMARIL® | EXPERIMENTAL | Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30. |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis virus; Yellow fever virus | BIOLOGICAL | ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30. |
| Yellow fever virus; Live attenuated Japanese encephalitis virus | BIOLOGICAL | STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30. |
Inclusion Criteria : * All aspects of the protocol explained and written informed consent obtained from the participant. * Aged ≥ 18 to ≤ 55 years at Day 0. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory re...
It is a Phase 2 vaccine candidate developed by Sanofi that combines live attenuated Japanese encephalitis virus and yellow fever virus components. It was studied in a single completed Phase 2 trial in Australia, and the program is directed at Japanese encephalitis, an infectious disease indication.
It is being developed for Japanese encephalitis, an infectious disease of the central nervous system. The Phase 2 study also listed yellow fever among the conditions examined. The candidate is not approved and remains in clinical development under Sanofi.
Sanofi, which trades under the ticker SNY, is the developer of this live attenuated Japanese encephalitis and yellow fever vaccine candidate. The company sponsored the Phase 2 study of the combined vaccine in Australia.
It is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The candidate is investigational and has not been approved for use.
The trial is NCT00982137, titled Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax-JE) and Yellow Fever Vaccine (STAMARIL). It was a completed Phase 2 randomized, double-blind, controlled study that enrolled 108 participants aged 18 years and older in Australia.
The Phase 2 study of this combined live attenuated Japanese encephalitis and yellow fever vaccine candidate evaluated ChimeriVax-JE alongside STAMARIL, the yellow fever vaccine. The trial examined both the Japanese encephalitis and yellow fever vaccine components in the same study population.