Japanese Encephalitis
Conditions
Keywords
Japanese Encephalitis, ChimeriVax™-JE Vaccine, Adult
Brief 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.
Detailed description
All participants will received a single dose of study vaccine, ChimeriVax™-JE or placebo on Day 0. The double-blind treatment phase will last 30 days, with follow-up visits at 6 and 12 months.
Interventions
BIOLOGICALLive attenuated Japanese encephalitis virus
0.5 mL,Subcutaneous
BIOLOGICALChimeriVax™ diluent (Placebo)
0.5 mL, Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
: * All aspects of the protocol explained and written informed consent obtained from the participant. * Aged ≥18 to \< 49 years. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results. * Participant must be available for the study duration, including all planned follow-up visits. * Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate. * For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal \[at least one year since last menstrual period\]).
Exclusion criteria
: * A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject). * Previous or current military service. * History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more. * Known or suspected immunodeficiency (e.g., human immunodeficiency virus \[HIV\] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids \> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 11 and Day 30 post-vaccination | Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline. |
| 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 | Day 30 post-vaccination | Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline. |
| 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 | Day 0 (post-vaccination) up to Day 30 post-vaccination | Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 11 and Day 30 post-vaccination | Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. |
| 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 | Day 30 post-vaccination | The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. |
| Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Day 30 up to 12 months post-vaccination | Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer \< 1:10. |
Countries
Australia
Participant flow
Recruitment details
Participants were enrolled from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia.
Pre-assignment details
A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| ChimeriVax™-JE 3 log10 PFU All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0. | 32 |
| ChimeriVax™-JE 4 log10 PFU All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0. | 32 |
| ChimeriVax™-JE 5 log10 PFU All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0 | 32 |
| Placebo All participants received a single dose of Placebo (diluent) on Day 0. | 32 |
| Total | 128 |
Baseline characteristics
| Characteristic | ChimeriVax™-JE 4 log10 PFU | ChimeriVax™-JE 5 log10 PFU | ChimeriVax™-JE 3 log10 PFU | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 32 Participants | 32 Participants | 32 Participants | 128 Participants |
| Age Continuous | 26.7 Years STANDARD_DEVIATION 9.17 | 27.4 Years STANDARD_DEVIATION 8.31 | 29.3 Years STANDARD_DEVIATION 7.62 | 29.4 Years STANDARD_DEVIATION 8.43 | 28.2 Years STANDARD_DEVIATION 8.38 |
| Region of Enrollment Australia | 32 Participants | 32 Participants | 32 Participants | 32 Participants | 128 Participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 15 Participants | 16 Participants | 64 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 17 Participants | 16 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 32 | 16 / 32 | 16 / 32 | 17 / 32 |
| serious Total, serious adverse events | 2 / 32 | 1 / 32 | 0 / 32 | 2 / 32 |
Outcome results
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
Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.
Time frame: Day 0 (post-vaccination) up to Day 30 post-vaccination
Population: Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | 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 | Neutropenia | 4 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Abdominal Pain | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Pharyngitis | 2 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Diarrhea Infectious | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Rhinorrhea | 2 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Pruritus | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Diarrhea | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Leukopenia | 2 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Lymphadenopathy | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Erythema | 2 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Pain | 1 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Reaction | 1 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Hemorrhage | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Induration | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Injection Site Paresthesia | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Headache | 11 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Lethargy | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Fatigue | 6 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Malaise | 4 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Feeling Hot | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Chills | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Myalgia | 2 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Arthralgia | 0 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Nausea | 0 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Nausea | 6 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Hemorrhage | 3 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Diarrhea Infectious | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Arthralgia | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Myalgia | 6 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Induration | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Lymphadenopathy | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Lethargy | 4 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Pruritus | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Paresthesia | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Pharyngitis | 3 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Headache | 9 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Chills | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Erythema | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Feeling Hot | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Pain | 2 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Leukopenia | 3 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Abdominal Pain | 4 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Neutropenia | 0 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Malaise | 7 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Diarrhea | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Injection Site Reaction | 0 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Rhinorrhea | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Fatigue | 11 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Erythema | 4 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Neutropenia | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Leukopenia | 0 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Lymphadenopathy | 1 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Chills | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Pain | 4 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Feeling Hot | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Reaction | 0 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Hemorrhage | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Induration | 0 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Myalgia | 9 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Injection Site Paresthesia | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Headache | 13 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Nausea | 3 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Lethargy | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Fatigue | 7 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Arthralgia | 2 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Diarrhea | 4 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Abdominal Pain | 1 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Malaise | 5 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Pharyngitis | 3 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Diarrhea Infectious | 0 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Rhinorrhea | 0 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Pruritus | 1 Participants |
| Placebo | 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 | Arthralgia | 0 Participants |
| Placebo | 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 | Chills | 1 Participants |
| Placebo | 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 | Leukopenia | 0 Participants |
| Placebo | 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 | Diarrhea | 2 Participants |
| Placebo | 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 | Injection Site Erythema | 0 Participants |
| Placebo | 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 | Injection Site Pain | 2 Participants |
| Placebo | 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 | Pruritus | 2 Participants |
| Placebo | 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 | Abdominal Pain | 1 Participants |
| Placebo | 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 | Rhinorrhea | 1 Participants |
| Placebo | 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 | Lymphadenopathy | 1 Participants |
| Placebo | 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 | Feeling Hot | 3 Participants |
| Placebo | 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 | Pharyngitis | 4 Participants |
| Placebo | 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 | Myalgia | 2 Participants |
| Placebo | 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 | Injection Site Paresthesia | 1 Participants |
| Placebo | 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 | Malaise | 2 Participants |
| Placebo | 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 | Headache | 11 Participants |
| Placebo | 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 | Nausea | 2 Participants |
| Placebo | 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 | Injection Site Induration | 0 Participants |
| Placebo | 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 | Neutropenia | 0 Participants |
| Placebo | 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 | Lethargy | 2 Participants |
| Placebo | 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 | Injection Site Hemorrhage | 1 Participants |
| Placebo | 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 | Injection Site Reaction | 1 Participants |
| Placebo | 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 | Diarrhea Infectious | 0 Participants |
| Placebo | 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 | Fatigue | 6 Participants |
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
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Time frame: Day 11 and Day 30 post-vaccination
Population: Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | 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 | Day 11 | 1 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Day 30 | 31 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Day 30 | 30 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Day 11 | 10 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Day 11 | 8 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Day 30 | 29 Participants |
| Placebo | 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 | Day 11 | 0 Participants |
| Placebo | 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 | Day 30 | 1 Participants |
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
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.
Time frame: Day 30 post-vaccination
Population: Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype I | 31 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype II | 25 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III Beijing | 31 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III P3 | 30 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III Nakayama | 31 Participants |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype IV | 25 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype IV | 28 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III P3 | 29 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype I | 28 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III Beijing | 30 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype II | 25 Participants |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III Nakayama | 27 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype II | 25 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III Beijing | 30 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III P3 | 29 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype IV | 26 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III Nakayama | 27 Participants |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype I | 30 Participants |
| Placebo | 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 | Genotype III Nakayama | 1 Participants |
| Placebo | 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 | Genotype IV | 0 Participants |
| Placebo | 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 | Genotype II | 0 Participants |
| Placebo | 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 | Genotype III P3 | 0 Participants |
| Placebo | 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 | Genotype I | 1 Participants |
| Placebo | 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 | Genotype III Beijing | 1 Participants |
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
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.
Time frame: Day 11 and Day 30 post-vaccination
Population: Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 11 | 5.2 Titers |
| ChimeriVax™-JE 3 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 30 | 1829.6 Titers |
| ChimeriVax™-JE 4 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 30 | 2151.5 Titers |
| ChimeriVax™-JE 4 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 11 | 11.4 Titers |
| ChimeriVax™-JE 5 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 11 | 10.2 Titers |
| ChimeriVax™-JE 5 log10 PFU | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 30 | 1956.5 Titers |
| Placebo | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 11 | 5.0 Titers |
| Placebo | Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo | Day 30 | 5.8 Titers |
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
The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.
Time frame: Day 30 post-vaccination
Population: Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype I | 208.6 Titers |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype II | 50.9 Titers |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III (Beijing) | 232.6 Titers |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III (P3) | 223.6 Titers |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype III (Nakayama) | 192.3 Titers |
| ChimeriVax™-JE 3 log10 PFU | 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 | Genotype IV | 70.4 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype IV | 80.4 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III (P3) | 238.7 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype I | 193.0 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III (Beijing) | 162.3 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype II | 69.2 Titers |
| ChimeriVax™-JE 4 log10 PFU | 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 | Genotype III (Nakayama) | 180.6 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype II | 49.6 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III (Beijing) | 253.4 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III (P3) | 315.5 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype IV | 67.1 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype III (Nakayama) | 155.0 Titers |
| ChimeriVax™-JE 5 log10 PFU | 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 | Genotype I | 188.3 Titers |
| Placebo | 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 | Genotype III (Nakayama) | 5.6 Titers |
| Placebo | 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 | Genotype IV | 5.0 Titers |
| Placebo | 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 | Genotype II | 5.0 Titers |
| Placebo | 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 | Genotype III (P3) | 5.3 Titers |
| Placebo | 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 | Genotype I | 5.3 Titers |
| Placebo | 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 | Genotype III (Beijing) | 5.4 Titers |
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
Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer \< 1:10.
Time frame: Day 30 up to 12 months post-vaccination
Population: Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE 3 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Day 30 [N = 31; 32; 31; 32] | 31 Participants |
| ChimeriVax™-JE 3 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 12 [N = 31; 30; 30; 29] | 27 Participants |
| ChimeriVax™-JE 3 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 6 [N = 31; 30; 28; 32] | 30 Participants |
| ChimeriVax™-JE 4 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Day 30 [N = 31; 32; 31; 32] | 30 Participants |
| ChimeriVax™-JE 4 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 12 [N = 31; 30; 30; 29] | 26 Participants |
| ChimeriVax™-JE 4 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 6 [N = 31; 30; 28; 32] | 28 Participants |
| ChimeriVax™-JE 5 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 6 [N = 31; 30; 28; 32] | 27 Participants |
| ChimeriVax™-JE 5 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Day 30 [N = 31; 32; 31; 32] | 29 Participants |
| ChimeriVax™-JE 5 log10 PFU | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 12 [N = 31; 30; 30; 29] | 29 Participants |
| Placebo | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Day 30 [N = 31; 32; 31; 32] | 1 Participants |
| Placebo | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 12 [N = 31; 30; 30; 29] | 0 Participants |
| Placebo | Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo | Month 6 [N = 31; 30; 28; 32] | 0 Participants |