Healthy volunteers: Immunization against Japanese Encephalitis virus (JEV)
Conditions
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years of age - Written informed consent 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: - History of clinical manifestation of any flavivirus infection - History of vaccination against Japenese Encephalitis (JE), yellow fever and Dengue fever (an anti-JEV neutralizing antibody titre =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 investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of the study vaccine. - Planned administration of another vaccine during the study period - Immunodeficiency including post-organ transplantation or immunosuppressive therapy - A family history of congenital or hereditary immunodeficiency - History of autoimmune disease - Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs 4 weeks before first administration of study vaccine.(for corticosteroids, this will mean Prednisolone, or equivalent, =0.05 mg/kg/day. Topical and inhaled steroids are allowed). - Any acute infections within 4 weeks prior to enrolment - History of severe hypersensitivity reactions (in particular to a component of the IC51 vaccine, e.g. protamine sulphate), anaphylaxis or severe cases of atrophy requiring emergency treatment or hospital admission - Infection with HIV (a negative test result within 30 days before enrollment is acceptable), Hepatitis B or C. - History of Urticaria after hymenoptera envenomation, drugs, physical or other provocation, or of idiopathic cause. - Drug and alcohol addition within 6 months prior to enrollment (including alcohol dependence, i.e. more than 60 g alcohol per day, or conditions which might interfere with the study conduct i.e. lack of compliance due to positive drug screening) - Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, history of malignancy in the past 5 years - Pregnancy (positive pregnancy test during run-in or baseline), lactation or unreliable contraception, childbearing potential, and willingness to become pregnant, in female subjects during the study period and 30 days after the last vaccination (for details please refer to protocol section 6.4). - Inability or unwillingness to provide informed consent and to abide by the requirements fo the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate the non-inferiority of IC51 (JE-PIV) (1 x 12 mcg) versus IC51 (JE-PIV) (2 x 6 mcg) in terms of seroconversion rate at day 56 after the first vaccination.;Primary end point(s): The primary endpoint is the seroconversion rate defined as percentage of subjects with = 1:10 anti-JEV neutralizing antibody titer (PRNT) at day 56.; Secondary Objective: - To analyse the immunogenicity of a rapid immunization, single vaccination scheme IC51 (JE-PIV) (1 x 12 mcg) vs. IC51 (JE-PIV) (1 x 6 mcg) and the standard vaccination scheme IC51 (JE-PIV) (2 x 6 mcg) vs, IC51 (JE-PIV) (1 x 6 mcg) in terms of superiority of the seroconversion rate 10, 28, 35 and 56 days after the first vaccination. - To compare geometric mean antibody titers (GMT) of both regimes. - To confirm the safety profile of IC51 (JE-PIV). | — |
Countries
Germany, United Kingdom
Outcome results
None listed