Japanese Encephalitis (JE)
Conditions
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -At least 18 years of age -Subjects correctly included in and having completed study IC51 309 (i.e. received both IC51 vaccinations within the accepted time windows and completed all visits including the 6-months follow-up) without having any major protocol violations -In female subjects, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception, as specified in protocol Section 6.4 -Written informed consent obtained prior to study entry (subjects should give their consent themselves) 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 JE (except IC51 administered in study IC51-309), Yellow fever, Dengue fever and West Nile virus •Use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC51 vaccination at Visit 1 and during the study period •Administration of any vaccine within 4 weeks prior to IC51 vaccination at Visit 1 •Administration of a vaccine (except the study vaccine) against a flaviviral infection, e.g. JE, tick-borne encephalitis (TBE), Yellow fever, Dengue fever or West Nile virus during the study •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 within 4 weeks prior to IC51 vaccination at Visit 1 and during the study. (For corticosteroids, this will mean prednisone, or equivalent, >=0.05 mg/kg/day. Topical and inhaled steroids are allowed.) •Any acute infections within 4 weeks prior to vaccination at Visit 1 •History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission •Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV •History of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause •Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approximately 60 g alcohol per day, or conditions which might interfere with the study conduct) •Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination •Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, or history of malignancy in the past 5 years •Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects with child-bearing potential (for details, please refer to Section 6.4) •Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion •Inability or unwillingness to provide informed consent and to abide by the requirements of the study •Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate (SCR) at Month 12 after the booster vaccination (Month 27 after primary immunization);Secondary Objective: -To assess the effect of a booster vaccination on immunogenicity of IC51 in terms of SCR at Day28 and Month 6 after the booster vaccination (Months 16 and 21 after primary immunization) -To assess the effect of a booster vaccination on immunogenicity of IC51 in terms of geometric mean titer (GMT) for anti-Japanese Encephalitis virus (JEV) neutralizing antibodies at Day 28, Month 6 and Month 12 after the booster vaccination (Months 16, 21 and 27 after primary immunization) -To investigate tolerability of a booster vaccination until Day 28 after the booster vaccination -To analyze the rates of serious adverse events (SAEs) and medically attended adverse events (AEs) in individuals after a booster vaccination with IC51 -To assess changes in laboratory parameters ;Primary end point(s): Seroconversion rate as defined by the percentage of subjects with >=1:10 anti-JEV neutralizing antibody titer (plaque reduction neutralization test [PRNT]) at Month 12 after the booster vaccination (Month 27 after primary immunization) | — |
Countries
Austria, Germany
Outcome results
None listed