none
Conditions
Interventions
Subcutaneous injection arm: JEBIK V (0.5mL) is injected subcutaneously on the upper arm twice at intervals of 3 weeks, then the neutralizing antibody titer contained in the serum is measured.
Micronee
Sponsors
Hiroaki Iwata
Fujifilm Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Persons aged 20 or older and less than 35 (at the time of informed consent)
Exclusion criteria
Exclusion criteria: 1. Persons with an obvious fever (37.5C or higher) 2. Persons who have dermatosis to disrupt administration of investigational drugs 3. Persons who have immune deficiency disease (ex. AIDS, PID) 4. Persons who are vaccinated with Japanese encephalitis vaccine 5. Persons who have had Japanese encephalitis in the past 6. Persons who have had serious reaction (ex.anaphylaxis) to a vaccine in the past 7. Persons who have had a seizure in the past 8. Persons with a severe acute illness 9. Persons who are vaccinated with inactivated vaccine within 6 days 10. Persons who are vaccinated with live vaccine within 27 days 11. Persons who have had a blood transfusion or administration with gamma globulin in the past 90 days 12. Persons who were positive to antibody test for Japanese encephalitis virus at preliminary screening 13. Persons who were detected of HIV antigen/antibody, HBs antigen, HCV antibody, TP antibody, HTLV-1 antibody at preliminary screening 14. Females who are pregnant, wish to become pregnant, are breastfeeding, have difficulty contraception using contraceptive devices (pessary, condom) during the study period 15. Persons deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining neutralizing antibody titer of Japanese encephalitis virus in blood serum at 6 weeks after microneedle array administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determining neutralizing antibody titer of Japanese encephalitis virus in blood serum before and after microneedle array administration 2. Determining neutralizing antibody titer seroconversion rate of Japanese encephalitis virus in blood serum after microneedle array administration 3. Confirmation of the relationship between dosage of Japanese encephalitis vaccine and neutralizing antibody titer of Japanese encephalitis virus in blood serum 4. Confirmation of safety for inoculation of Japanese encephalitis vaccine by microneedle array administration | — |
Contacts
Public ContactIwata Hiroaki
Hokkaido University Hospital
Outcome results
None listed