JPRN-jRCTs011190004已完成1 期
Clinical trial of dose response using microneedle array containing Japanese encephalitis vaccine in healthy adult individuals
Hiroaki Iwata0 个研究点目标入组 39 人开始时间: 2019年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 35age old（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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