Phase 2
N=128
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00981630 ↗Enrolled (actual)
128
Serious AEs
3.9%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo — 1; 10; 8; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Live attenuated Japanese encephalitis virus (Biological); ChimeriVax™ diluent (Placebo) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo |
1; 10; 8; 0; 31; 30 | — |
| PRIMARY Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo |
31; 28; 30; 1; 25; 25 | — |
| PRIMARY Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo |
1; 2; 4; 2; 2; 2 | — |
| SECONDARY Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo |
5.2; 11.4; 10.2; 5.0; 1829.6; 2151.5 | — |
| SECONDARY Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo |
208.6; 193.0; 188.3; 5.3; 50.9; 69.2 | — |
| SECONDARY Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo |
31; 30; 29; 1; 30; 28 | — |
Summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo.
Primary Objectives:
Safety:
* To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).
Immunogenicity:
* To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity.
* To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.
Eligibility Criteria
Inclusion Criteria
- All aspects of the protocol explained and written informed consent obtained from the participant.
- Aged ≥18 to 10 mg prednisone, or equivalent, in the last three months or during the trial (up to Day 30).
- History of thymoma, thymic surgery (removal) or myasthenia gravis.
- Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe criteria described in the toxicity gradings for laboratory values).
- Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, hymenoptera (bee family) stings, or drugs (including vaccines).
- 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 30.
- Administration of another vaccine or antiviral within 30 days preceding the screening visit or up to Day 30 (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 (participant may be rescheduled).
- Intention to travel out of the area prior to the study visit on Day 30.
- Seropositive to hepatitis C virus or HIV or positive for Hepatitis B Surface 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, ischaemia, infection, inflammation of the brain).
- Intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 30.
Data sourced from ClinicalTrials.gov (NCT00981630). 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.