Phase 2
N=202
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
Encephalitis · Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00981175 ↗Enrolled (actual)
202
Serious AEs
0.6%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose — 194; 191 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Live attenuated Japanese encephalitis virus, then ChimeriVax diluent (Biological); ChimeriVax diluent, then Live attenuated Japanese encephalitis virus (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jun 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose |
194; 191 | — |
| PRIMARY 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. |
7; 5; 0; 6; 4; 0 | — |
| SECONDARY 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. |
95; 90; 97; NA; 93; 87 | — |
| SECONDARY 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. |
79; 72; 78; 68 | — |
| SECONDARY 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. |
69; 64; 67; 60 | — |
| SECONDARY Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. |
47; 45; 4; 12; 10; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
At entry:
- All aspects of the protocol explained and written informed consent obtained from the subject.
- Aged ≥ 18 to 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
- Clinically significant abnormalities on laboratory assessment.
- Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine.
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 56.
- Administration of another vaccine within 30 days preceding the screening visit or up to Day 56 (these subjects will be rescheduled for vaccination at a later date).
- Physical examination indicating any clinically significant medical condition.
- Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to inoculation (subject may be rescheduled).
- Intention to travel out of the area prior to the study visit on Day 56.
- Seropositive to hepatitis C virus (HCV) or HIV or positive for hepatitis B (HBV) (antigen).
- Lactation or intended pregnancy in female subjects.
- Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g., significant hypertensive cerebrovascular disease, trauma, ischemia, infection, inflammation of the brain).
For long-term immunogenicity follow-up period:
- History of Yellow Fever or out of study JE vaccination or known flavivirus infection since receiving ChimeriVax™-JE vaccination on Day 0 or Day 28 (during double-blind treatment period of the study). Yellow Fever/JE vaccination or flavivirus infection will be determined by history (interview of subject) and/or by reviewing the subject's medical records. Please note subjects who were flavivirus positive at Day 0 will be allowed to enrol on the study.
- Participation in another JE clinical study.
Data sourced from ClinicalTrials.gov (NCT00981175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.