The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults. Objectives: Safety: * Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to \<55 years) without prior Japanese encephalitis (JE) vaccination. Immunogenicity: * Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE * Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.
Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and 60 months after Day 0. No safety data will be collected in the long-term immunogenicity follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
202
ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
Unnamed facility
Enoggera, Queensland, Australia
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Time frame: Day 28 post-vaccination
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
Time frame: Days 0 to 28 post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.
Time frame: Month 6 pre- and post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.
Time frame: Month 12 post-vaccination
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.
Time frame: Month 24 post-vaccination
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.
Time frame: Day 0 up to 28 post-vaccination
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