Japanese Encephalitis
Conditions
Brief summary
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
Interventions
IC51 6 mcg i.m. injection on Day 0 and Day 28
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Main 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 Main
Exclusion criteria
* History of immunodeficiency or immunosuppressive therapy, * Known Human Immunodeficiency Virus (HIV); OR * Drug addiction including alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion Rate | Day 56 |
| Safety and Adverse Events | Day 56 |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC51 Batch IC51/07E/006A | 130 |
| IC51 Batch IC51/07E/007A | 129 |
| IC51 Batch IC51/07E/008A | 128 |
| Total | 387 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | administrative reason | 0 | 0 | 1 |
| Overall Study | Adverse Event | 4 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | IC51 Batch IC51/07E/007A | IC51 Batch IC51/07E/008A | IC51 Batch IC51/07E/006A | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 128 Participants | 127 Participants | 130 Participants | 385 Participants |
| Age, Continuous | 28.9 years STANDARD_DEVIATION 9.4 | 30.2 years STANDARD_DEVIATION 10.5 | 29.3 years STANDARD_DEVIATION 8.6 | 29.5 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Europe | 129 participants | 128 participants | 130 participants | 387 participants |
| Sex: Female, Male Female | 83 Participants | 74 Participants | 71 Participants | 228 Participants |
| Sex: Female, Male Male | 46 Participants | 54 Participants | 59 Participants | 159 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 | 64 / 130 | 74 / 129 | 74 / 128 |
| serious Total, serious adverse events | 2 / 130 | 1 / 129 | 0 / 128 |
Outcome results
Primary
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Time frame: Day 56
Population: Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC51 Batch IC51/07E/006A | Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | 160.8 titers | Standard Deviation 398 |
| IC51 Batch IC51/07E/007A | Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | 188.2 titers | Standard Deviation 410.2 |
| IC51 Batch IC51/07E/008A | Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | 168.4 titers | Standard Deviation 483.6 |
Secondary
Safety and Adverse Events
Time frame: Day 56
Secondary
Seroconversion Rate
Time frame: Day 56