Japanese Encephalitis
Conditions
Brief summary
The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.
Detailed description
Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years. The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51
Interventions
BIOLOGICALIC51
6 mcg im. at day 0 and day 28
Sponsors
Valneva Austria GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.
Exclusion criteria
* History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: 1. Geometric Mean Titers (GMT) at Day 56 | 56 days post 1st vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability | see above |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC51 Cohort 1 vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \
12 months after filling; | 98 |
| IC51 Cohort 2 vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \
18 months after filling; | 103 |
| IC51 Cohort 3 vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \
24 months after filling; | 102 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 5 |
| Overall Study | Not vaccinated at Day 0 | 1 | 0 | 0 |
| Overall Study | Subject missed Visit 4 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | IC51 Cohort 2 | IC51 Cohort 3 | IC51 Cohort 1 | Total |
|---|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 10.7 | 31.6 years STANDARD_DEVIATION 10.7 | 27.3 years STANDARD_DEVIATION 7.6 | 29.2 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Asian | 5 participants | 0 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian/ White | 98 participants | 102 participants | 93 participants | 293 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 55 Participants | 51 Participants | 61 Participants | 167 Participants |
| Sex: Female, Male Male | 48 Participants | 51 Participants | 37 Participants | 136 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 | 66 / 98 | 58 / 103 | 61 / 102 |
| serious Total, serious adverse events | 2 / 98 | 1 / 103 | 0 / 102 |
Outcome results
Primary
Primary: 1. Geometric Mean Titers (GMT) at Day 56
Time frame: 56 days post 1st vaccination
Population: Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| IC51 Cohort 1 | Primary: 1. Geometric Mean Titers (GMT) at Day 56 | 100.1 Geometric Mean Titer - Estimate |
| IC51 Cohort 2 | Primary: 1. Geometric Mean Titers (GMT) at Day 56 | 84.7 Geometric Mean Titer - Estimate |
| IC51 Cohort 3 | Primary: 1. Geometric Mean Titers (GMT) at Day 56 | 68.1 Geometric Mean Titer - Estimate |
Secondary
Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability
Time frame: see above