Healthy volunteers: Immunization against Japanese Encephalitis virus (JEV)
Conditions
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to study entry (subjects should give their consent themselves, consent by legal representatives is allowed). Written informed consent should be obtained during participation of IC51-304 study. 2. Subjects correctly included in and having completed study IC51-304 according to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period 2. Planned administration of another vaccine during the study period 3. Immunodeficiency including post-organ-transplantation or immunosuppressive therapy 4. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs since last visit of study IC51-304. (For corticosteroids, this will mean prednisone, or equivalent, greater than 0.5 mg/kg/day. Topical and inhaled steroids are allowed.) 5. Positive Pregnancy test, lactation or unreliable contraception, childbearing potential, and willingness to become pregnant, in female subjects up to 30 days after the last vaccination (for details please refer to protocol section 6.4) 6. Inability or unwillingness to provide informed consent and to abide by the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to analyze the long term persistence of immunogenicity of IC51 (JE-PIV) (2 x 6 mcg), IC51 (JE-PIV) (1 x 12 mcg) or IC51 (JE-PIV) (1 x 6 mcg) in terms of seroconversion rate in volunteers 24 months after the primary vaccination; Secondary Objective: a) To investigate the immunogenicity of a booster dose of IC51 (JE-PIV) (1 x 6 mcg) applied 11 months and/or 23 months after the primary vaccination in subjects with a negative PRNT result at month 6 and/or month 12 b) To analyze the immunogenicity of IC51 (JE-PIV) (2 x 6 mcg), IC51 (JE-PIV) (1 x 12 mcg) or IC51 (JE-PIV) (1 x 6 mcg) in volunteers 6 and 12 months after the primary vaccination c) To compare Geometric Mean Antibody Titers of both dose regimes d) To confirm the safety profile of IC51 (JE-PIV) ;Primary end point(s): Seroconversion rate (anti-JEV neutralizing antibody titer greater than or equal to 1:10) 24 months after the primary vaccination | — |
Countries
Germany, United Kingdom
Outcome results
None listed