Encephalitis, Japanese Encephalitis
Conditions
Keywords
Japanese Encephalitis, Japanese Encephalitis Vaccines, Adult
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALLive attenuated Japanese encephalitis virus, then ChimeriVax diluent
ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
BIOLOGICALChimeriVax diluent, then Live attenuated Japanese encephalitis virus
ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
: At entry: * All aspects of the protocol explained and written informed consent obtained from the subject. * Aged ≥ 18 to \< 55 years. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results. * Subject must be available for the study duration, including all planned follow-up visits. * Has the subject agreed to take the following precautions to avoid insect bites for 7 days following vaccination: (a) wear long-sleeved shirts and trousers?; (b) apply N,N-Diethyl-meta-toluamide (DEET)-containing insect repellents?; (c) Sleep in screened enclosures? * For female subjects of childbearing potential: Negative serum pregnancy tests. An efficacious hormonal (i.e., oral, implantable or injectable) or barrier method of birth control must be used at least 1 month before Screening and Month 6 and at least 1 month after Day 28 and Month 6. These subjects will sign an agreement that birth control will be practised during the specified periods and will specify the method used. Female subjects unable to bear children must have this documented (e.g., tubal ligation or hysterectomy). For long-term immunogenicity follow-up period: * Subject received an initial dose of ChimeriVax™-JE, has a baseline (Day 0) sample and at least one post-vaccination evaluable serological specimen for antibody analysis. * All aspects of the Long-term Immunogenicity Follow-up Period explained and updated written informed consent obtained from the subject. * In good general health, without significant medical history that may affect the efficacy endpoints or the ability to take blood samples.
Exclusion criteria
: * A history of vaccination to Japanese encephalitis (JE). Previous vaccination will be determined by history (interview of subject) and/or by reviewing the subject's vaccination card or other official documentation (either a history of or documentation of vaccination fulfils the criterion for exclusion). * 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, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose | Day 28 post-vaccination | 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. |
| 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. | Days 0 to 28 post-vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Month 6 pre- and post-vaccination | 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. |
| 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. | Month 12 post-vaccination | 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. |
| 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. | Month 24 post-vaccination | 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. |
| Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Day 0 up to 28 post-vaccination | Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination. |
Countries
Australia
Participant flow
Recruitment details
Participants were enrolled and vaccinated from 14 April 2003 to 05 January 2004 at 1 clinical center in Australia.
Pre-assignment details
A total of 202 participants who met the inclusion/exclusion criteria were enrolled and vaccinated. A subset of the participants also received a booster vaccine at month 6. A report on all participants who received the primary and booster vaccination and the primary vaccination only are presented.
Participants by arm
| Arm | Count |
|---|---|
| ChimeriVax™-JE Vaccine First , Then Placebo Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28. | 101 |
| Placebo First, Then ChimeriVax™-JE Vaccine Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28. | 101 |
| Booster ChimeriVax™-JE Vaccine Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28 | 0 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Booster Dose Vaccination | Lost to Follow-up | 2 | 3 |
| Primary Dose Vaccination | Adverse Event | 1 | 0 |
| Primary Dose Vaccination | Lost to Follow-up | 2 | 1 |
| Primary Dose Vaccination | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo First, Then ChimeriVax™-JE Vaccine | ChimeriVax™-JE Vaccine First , Then Placebo | Total |
|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 0 participants | 0 participants | 0 participants |
| Age Categorical Between 18 and 65 years | 101 participants | 101 participants | 202 participants |
| Age Continuous | 27.7 Years STANDARD_DEVIATION 8.25 | 26.1 Years STANDARD_DEVIATION 7.36 | 26.9 Years STANDARD_DEVIATION 7.84 |
| Gender Female | 15 participants | 13 participants | 28 participants |
| Gender Male | 86 participants | 88 participants | 174 participants |
| Region of Enrollment Australia | 101 participants | 101 participants | 202 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 201 | 35 / 199 | 3 / 98 |
| serious Total, serious adverse events | 2 / 201 | 1 / 199 | 0 / 98 |
Outcome results
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.
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
Population: Injection site reactions were assessed in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Pain | 7 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Reaction NOS | 6 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Erythema | 4 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Swelling | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Bruising | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Nodule | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Pigmentation Changes | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or 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. | Injection site Pruritus | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Erythema | 5 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Pigmentation Changes | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Swelling | 6 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Bruising | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Nodule | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Pain | 5 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Reaction NOS | 4 Participants |
| Booster ChimeriVax™-JE Vaccine | 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 Pruritus | 0 Participants |
| No Booster Vaccine | 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 Erythema | 0 Participants |
| No Booster Vaccine | 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 Reaction NOS | 0 Participants |
| No Booster Vaccine | 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 Pain | 0 Participants |
| No Booster Vaccine | 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 Swelling | 1 Participants |
| No Booster Vaccine | 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 Pigmentation Changes | 0 Participants |
| No Booster Vaccine | 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 Nodule | 0 Participants |
| No Booster Vaccine | 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 Bruising | 0 Participants |
| No Booster Vaccine | 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 Pruritus | 0 Participants |
Primary
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
Population: Immunogenicity was assessed in the Intent-to-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose | PRNT50 ≥ 10 [N = 197] | 194 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose | PRNT50 ≥ 20 [N = 197] | 191 Participants |
Secondary
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
Population: Treatment emergent adverse events were assessed in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pruritus | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Diarrhea Not Otherwise Specified | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Reaction Not Otherwise Specified | 6 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pigmentation Changes | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Nausea | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Contusion | 0 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Nodule | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pyrexia | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Insomnia | 0 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Bruising | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Liver Function Test Abnormal | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lethargy | 5 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Vomiting Not Otherwise Specified | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Myalgia | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Headache | 12 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Upper Respiratory Tract Infection NOS | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pharygolaryngeal Pain | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Viral Infection Not Otherwise Specified | 5 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Any Adverse Event | 47 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Anorexia | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Erythema | 4 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Disturbance in Attention | 0 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Gastroenteritis Not Otherwise Specified | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Fatigue | 3 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pain | 7 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Rigors | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lymphadenopathy | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Flushing | 0 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Malaise | 1 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Swelling | 2 Participants |
| ChimeriVax™-JE Vaccine (Single or Primary) | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Dry Eyes Not Otherwise Specified | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Insomnia | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Any Adverse Event | 45 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Headache | 10 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pain | 5 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Reaction Not Otherwise Specified | 4 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lethargy | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Viral Infection Not Otherwise Specified | 10 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Erythema | 5 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Fatigue | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lymphadenopathy | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Swelling | 6 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Diarrhea Not Otherwise Specified | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Nausea | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pyrexia | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Liver Function Test Abnormal | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Myalgia | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Upper Respiratory Tract Infection NOS | 9 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Vomiting Not Otherwise Specified | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Bruising | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Nodule | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pigmentation Changes | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pruritus | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Malaise | 2 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Rigors | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Gastroenteritis Not Otherwise Specified | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Anorexia | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pharygolaryngeal Pain | 0 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Flushing | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Dry Eyes Not Otherwise Specified | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Disturbance in Attention | 1 Participants |
| Booster ChimeriVax™-JE Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Contusion | 1 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Swelling | 1 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pain | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pruritus | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lymphadenopathy | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Flushing | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Malaise | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Fatigue | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Dry Eyes Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Rigors | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Erythema | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Headache | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Gastroenteritis Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Viral Infection Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Contusion | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Anorexia | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Lethargy | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Myalgia | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Disturbance in Attention | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Upper Respiratory Tract Infection NOS | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Liver Function Test Abnormal | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pharygolaryngeal Pain | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Vomiting Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Pyrexia | 3 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Reaction Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Bruising | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Nausea | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Any Adverse Event | 4 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Nodule | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Diarrhea Not Otherwise Specified | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Insomnia | 0 Participants |
| No Booster Vaccine | Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment. | Injection Site Pigmentation Changes | 0 Participants |
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.
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
Population: Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Booster ChimeriVax™-JE Vaccine | 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. | Pre-booster PRNT50 ≥ 10 [N = 0, 98, 93] | 95 Participants |
| Booster ChimeriVax™-JE Vaccine | 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. | Post-booster PRNT50 ≥ 10 [N = 0, 97, 0] | 97 Participants |
| Booster ChimeriVax™-JE Vaccine | 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. | Pre-booster PRNT50 ≥ 20 [N = 0, 98, 93] | 93 Participants |
| Booster ChimeriVax™-JE Vaccine | 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. | Post-booster PRNT50 ≥ 20 [N = 0, 97, 0] | 97 Participants |
| No Booster Vaccine | 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. | Post-booster PRNT50 ≥ 20 [N = 0, 97, 0] | NA Participants |
| No Booster Vaccine | 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. | Pre-booster PRNT50 ≥ 10 [N = 0, 98, 93] | 90 Participants |
| No Booster Vaccine | 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. | Pre-booster PRNT50 ≥ 20 [N = 0, 98, 93] | 87 Participants |
| No Booster Vaccine | 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. | Post-booster PRNT50 ≥ 10 [N = 0, 97, 0] | NA Participants |
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.
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
Population: Immunogenicity was assessed in the Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Booster ChimeriVax™-JE Vaccine | 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. | PRNT50 ≥ 10 [N = 0, 70, 71] | 69 Participants |
| Booster ChimeriVax™-JE Vaccine | 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. | PRNT50 ≥ 20 [N = 0, 70, 71] | 67 Participants |
| No Booster Vaccine | 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. | PRNT50 ≥ 20 [N = 0, 70, 71] | 60 Participants |
| No Booster Vaccine | 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. | PRNT50 ≥ 10 [N = 0, 70, 71] | 64 Participants |
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.
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
Population: Immunogenicity was assessed in the Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Booster ChimeriVax™-JE Vaccine | 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. | PRNT50 ≥ 10 [N = 0, 80, 76] | 79 Participants |
| Booster ChimeriVax™-JE Vaccine | 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. | PRNT50 ≥ 20 [N = 0, 80, 76] | 78 Participants |
| No Booster Vaccine | 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. | PRNT50 ≥ 10 [N = 0, 80, 76] | 72 Participants |
| No Booster Vaccine | 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. | PRNT50 ≥ 20 [N = 0, 80, 76] | 68 Participants |