Japanese Encephalitis
Conditions
Brief summary
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.
Interventions
Japanese Encephalitis purified inactivated vaccine
Sponsors
Valneva Austria GmbH
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects at least 18 years of age * Written informed consent obtained prior to study entry * Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination
Exclusion criteria
* Inability or unwillingness to provide informed consent and to abide the requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | 24 months after the first vaccination | first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | 6, 12, 36, 48 and 60 months after 1st vaccination |
| Geometric Mean Titers | 6, 12, 36, 48 and 60 months |
| Adverse Events | 6, 12, 24, 36, 48 and 60 months after 1st vaccination |
Participant flow
Recruitment details
study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302
Participants by arm
| Arm | Count |
|---|---|
| IC51 no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 | 2,283 |
| JE-VAX no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301 | 338 |
| Placebo no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302 | 637 |
| Total | 3,258 |
Baseline characteristics
| Characteristic | IC51 | JE-VAX | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 13.8 | 42.3 years STANDARD_DEVIATION 14.1 | 33.5 years STANDARD_DEVIATION 13 | 35.6 years STANDARD_DEVIATION 13.9 |
| Race/Ethnicity, Customized Asian | 38 participants | 1 participants | 16 participants | 55 participants |
| Race/Ethnicity, Customized Black or African American | 101 participants | 35 participants | 25 participants | 161 participants |
| Race/Ethnicity, Customized Caucasian | 2076 participants | 288 participants | 574 participants | 2938 participants |
| Race/Ethnicity, Customized Other | 68 participants | 14 participants | 22 participants | 104 participants |
| Sex: Female, Male Female | 1274 Participants | 201 Participants | 365 Participants | 1840 Participants |
| Sex: Female, Male Male | 1009 Participants | 137 Participants | 272 Participants | 1418 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 | 78 / 2,283 | 16 / 338 | 31 / 637 | 54 / 102 |
| serious Total, serious adverse events | 15 / 2,283 | 2 / 338 | 7 / 637 | 14 / 102 |
Outcome results
Primary
Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302
Time frame: 24 months after the first vaccination
Population: subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IC51 | Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | 81.8 percentage of subjects |
Secondary
Adverse Events
Time frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination
Secondary
Geometric Mean Titers
Time frame: 6, 12, 36, 48 and 60 months
Secondary
Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
Time frame: 6, 12, 36, 48 and 60 months after 1st vaccination