18-64 years old volunteers with general good health
Conditions
Interventions
Trade Name: Ixiaro
Pharmaceutical Form:
Other descriptive name: JAPANESE ENCEPHALITIS VIRUS STRAIN SA14-14-2 (INACTIVATED) PRODUCED IN VERO CELLS
Sponsors
Helsinki University Centrel Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18-64 2. General good health as established by medical history and physical examination 3. Written informed consent 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. 5. Available for all visits scheduled in this study. 6. No previous Japanese encephalitis vaccination 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 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous Japanese encephalitis vaccination 2. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 4. Pregnancy or lactation 5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C). 6. Alcohol or drug abuse 7. Suspected non-compliance 8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period 9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 10. Employee at the investigational site, relative or spouse of the investigator 11. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To study whether one dose of intradermally given Ixiaro elicits a non-inferior immune response as compared to intramuscular administration of the same vaccine. The immune response is measured as levels of neutralizing serum antibodies (PRNT). ;Secondary Objective: - To study whether two doses of intradermally administered Ixiaro elicits a non-inferior immune response as compared to one dose of intramuscular administration of the same vaccine. - To compare the immune responses to one vs. two doses of intradermally administered Ixiaro - To study whether intradermally given Ixiaro has a non-inferior adverse event profile as compared to intramuscular administration of the same vaccine. - To study circulating plasmablasts (ELISPOT) and cell-mediated immune responses after intradermal vs. intramuscular Ixiaro. ;Primary end point(s): Measurement of levels of neutralizing serum antibodies (PRNT);Timepoint(s) of evaluation of this end point: One month after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From seven day to one month after vaccination to plasmablast and cell-mediated studies and from vaccine injection to 6 month to study adverse events.;Secondary end point(s): -To study circulating plasmablasts (ELISPOT) and cell-mediated immune responses after intradermal vs. intramuscular Ixiaro. - To study adverse event profiles | — |
Countries
Finland
Outcome results
None listed