Japanese Encephalitis
Conditions
Brief summary
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged \> or = 18 years
Detailed description
This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years. Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.
Interventions
BIOLOGICALIC51
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Written informed consent obtained prior to study entry
Exclusion criteria
* History of clinical manifestation of any flavivirus infection * History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) * Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine * Immunodeficiency including post-organ-transplantation or immunosuppressive therapy * A family history of congenital or hereditary immunodeficiency * History of autoimmune disease * Any acute infections within 4 weeks prior to enrollment * Infection with HIV, Hepatitis B or Hepatitis C * Pregnancy, lactation or unreliable contraception in female subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCR (Seroconversion Rate) at Day 56 | day 56 | Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCR at Day 10, 28 and 35 | Day 10, 28 and 35 | — |
| GMT at Day 10, 28, 35 and 56 | Day 10, 28, 35 and 56 | — |
| Safety | Study duration | AEs, Local and systemic tolerability, Safety laboratory parameters |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC51 2 x 6 mcg 2 x 6 mcg (microgram) | 125 |
| IC51 1 x 12 mcg 1 x 12 mcg (microgram) | 125 |
| IC51 1 x 6 mcg 1 x 6 mcg (microgram) | 124 |
| Total | 374 |
Baseline characteristics
| Characteristic | IC51 2 x 6 mcg | IC51 1 x 12 mcg | IC51 1 x 6 mcg | Total |
|---|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 14.2 | 41.2 years STANDARD_DEVIATION 15 | 41.6 years STANDARD_DEVIATION 14.8 | 40.8 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment Germany | 67 participants | 67 participants | 67 participants | 201 participants |
| Region of Enrollment United Kingdom | 58 participants | 58 participants | 57 participants | 173 participants |
| Sex: Female, Male Female | 71 Participants | 65 Participants | 61 Participants | 197 Participants |
| Sex: Female, Male Male | 54 Participants | 60 Participants | 63 Participants | 177 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 | 78 / 125 | 82 / 125 | 78 / 124 |
| serious Total, serious adverse events | 0 / 125 | 1 / 125 | 0 / 124 |
Outcome results
Primary
SCR (Seroconversion Rate) at Day 56
Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer
Time frame: day 56
Population: The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IC51 1 x 12 mcg | SCR (Seroconversion Rate) at Day 56 | 41.2 percentage of participants |
| IC51 2x6 mcg | SCR (Seroconversion Rate) at Day 56 | 97.3 percentage of participants |
| IC51 1x6 mcg | SCR (Seroconversion Rate) at Day 56 | 25.6 percentage of participants |
p-value: >0.99Mantel Haenszel
Secondary
GMT at Day 10, 28, 35 and 56
Time frame: Day 10, 28, 35 and 56
Secondary
Safety
AEs, Local and systemic tolerability, Safety laboratory parameters
Time frame: Study duration
Secondary
SCR at Day 10, 28 and 35
Time frame: Day 10, 28 and 35