背景:2022年5月,英国报告了一例没有海外旅行史的猴痘(目前称为“mpox”),其次是欧洲报告的感染报告,美国,和世界其他国家。由于正痘病毒属病毒(包括天花病毒,痘病毒,和牛痘病毒),据信,交叉免疫可以通过施用天花病毒疫苗来实现。在日本,天花疫苗(LC16m8株疫苗)已被批准;然而,在本研究的设计过程中,没有监管部门对水痘疫苗的批准.尽管人们认为暴露于痘病毒的个体可以接受天花疫苗作为预防天花的方法,现有证据尚不清楚。
目的:主要目的是评估LC16m8株疫苗的功效,在日本批准天花,用于对患水痘的个体密切接触者进行暴露后预防。次要目标是研究疫苗用于预防水痘的暴露后预防的安全性。
方法:该研究旨在招募100名接种疫苗的参与者,这些参与者被确定为与水痘患者的密切接触者。获得同意,参与者接种疫苗。每天记录症状(体温,头痛,皮疹,和副作用)直到第21天,然后在第28天再次进行。此外,研究者在第7,14,21和28天对不良事件进行了额外评估.考虑到水痘的最大潜伏期是21天,主要终点是密切接触21天后是否存在疾病.主要分析集中在4天内的病例,因为据报道,在这个时间范围内接种疫苗可以降低疾病的发病率。
结果:第一个试验参与者于2022年7月28日注册,研究期于2023年3月结束。研究结果将发表在同行评审的科学杂志上。
结论:这项研究使我们能够研究LC16m8株疫苗在暴露后预防水痘的有效性和安全性。
背景:日本临床试验注册中心jRCTs031220137;https://jrct。尼夫.走吧。jp/en-latest-detail/jRCTs031220137.
■DERR1-10.2196/46955。
BACKGROUND: In May 2022, a case of monkeypox (currently known as \"mpox\") with no history of overseas travel was reported in the United Kingdom, followed by reports of infections reported in Europe, the United States, and other countries worldwide. Due to the significant overlap in immune responses among viruses of the genus
Orthopoxvirus (including smallpox virus, mpox virus, and vaccinia virus), it is believed that cross-immunity can be achieved by administering the smallpox virus vaccine. In Japan, a smallpox vaccine (LC16m8 strain vaccine) has been approved; however, there was no regulatory approval for the mpox vaccine during the design of this
study. Although it is believed that individuals exposed to the mpox virus may receive smallpox vaccination as mpox prophylaxis, the existing evidence is not clear.
OBJECTIVE: The primary objective was to evaluate the efficacy of the LC16m8 strain vaccine, approved for smallpox in Japan, for postexposure prophylaxis against mpox when administered to close contacts of individuals with mpox. The secondary objective was to investigate the safety of the vaccine for postexposure prophylaxis against mpox.
METHODS: The
study aimed to enroll 100 vaccinated participants who had been identified as close contacts of individuals with mpox. Consent was obtained, and the participants are inoculated with the vaccine. Daily recordings of symptoms (body temperature, headache, rash, and side effects) were made until day 21 and then again on day 28. Furthermore, additional evaluations of adverse events were performed by the investigators on days 7, 14, 21, and 28. Considering that the maximum incubation period for mpox is 21 days, the primary end point is the presence or absence of the disease 21 days after close contact. The primary analysis focused on cases within 4 days of intense contact as it has been reported that vaccination within this timeframe can reduce the incidence of the disease.
RESULTS: The first
trial participant was enrolled on July 28, 2022, and the research period concluded in March 2023. The
study results will be published in a peer-reviewed scientific journal.
CONCLUSIONS: This study allowed us to investigate the efficacy and safety of the LC16m8 strain vaccine in postexposure prophylaxis against mpox.
BACKGROUND: Japan Registry of Clinical Trials jRCTs031220137; https://jrct.niph.go.jp/en-latest-detail/jRCTs031220137.
UNASSIGNED: DERR1-10.2196/46955.