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Live attenuated Japanese encephalitis virus; Yellow fever virus

Phase 2

Japanese Encephalitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 20, 2012

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Live attenuated Japanese encephalitis virus; Yellow fever virus · 1 trial · 2 indications

Phase 2 1
NCT00982137Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)Japanese Encephalitis
COMPLETED108 Analytics
PHASE2COMPLETED
Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
Japanese EncephalitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

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).

Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

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).

Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
Day 0 (Pre-vaccination) through Day 30 post-vaccination

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.

Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Day 0 up to Day 60 post-vaccination

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.

Secondary Endpoints

Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Day 0 through 6 months post-vaccination
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Day 0 through 6 months post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ChimeriVax™-JE then STAMARIL®EXPERIMENTALParticipants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30
STAMARIL® then ChimeriVax™-JEEXPERIMENTALParticipants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30
ChimeriVax™-JE and STAMARIL®, then DiluentEXPERIMENTALParticipants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30.
Diluent then ChimeriVax™-JE and STAMARIL®EXPERIMENTALParticipants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30.

Interventions

NameTypeDescription
Live attenuated Japanese encephalitis virus; Yellow fever virusBIOLOGICALChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.
Yellow fever virus; Live attenuated Japanese encephalitis virusBIOLOGICALSTAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Australia
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