Dose response study using microneedle array containing Japanese encephalitis vaccine

Phase 1

• Conditions: none

• Registration Number: JPRN-jRCTs011190004
• Lead Sponsor: Hiroaki Iwata

Brief Summary

As a result of administration of the MNA containing Japanese Encephalitis vaccine in healthy Japanese adults, the MNA-H produced a higher neutralizing antibody titer as compared with commercially available SC vaccine, and the MNA-L provided the same titer level as compared with the SC vaccine. Although the MNA groups caused slight skin irritation after administration, they have recovered in all cases. Therefore, we thought there were no serious issues with safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-30
• Study Completion: 2020-02-26
• Results First Posted: 2020-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 39

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified