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【感控前沿】美国FDA批准了预防旅行者霍乱疫苗2016-06-14 SIFIC热点团队 SIFIC官微
霍乱作为一个古老的传播疾病，在早期的流行中造成了重大人员死亡，包括注明哲学家黑格尔和音乐家柴可夫斯基，现代医疗的发展已经基本消灭霍乱的大规模传播，但是在一些偏远地区，水资源匮乏、卫生条件差地区仍有存在霍乱蔓延的可能，从近些年的报道看，在非洲地中海东部等国，霍乱疫情仍时有发生。近期美国FDA批准了预防旅行者感染霍乱的疫苗，为疫苗的普遍性适用开辟了一个新的道路。 FDA approves vaccine to prevent cholera for travelers美国食品药品监督管理局批准了预防旅行者感染霍乱的疫苗
检索：周密 译者：刘明星 臧金成 古丽米热·阿尔肯 王珍丽 审核：陈志锦
新闻发布美国食品药品监督管理局FDA批准了可预防霍乱的疫苗产品Vaxchora，该疫苗适用于计划前往霍乱受灾国家和地区的18-64岁成年旅行者，可预防由血清群O1霍乱弧菌(Vibrio cholerae)引发的霍乱。Vaxchora是唯一一种FDA批准的用于预防霍乱的疫苗。
霍乱（cholera）是因摄入受霍乱弧菌（Vibrio cholerae）污染的食物或水而引起的一种急性腹泻性传染病。感染症状可以很轻微，也可以非常严重。大多数情况下感染较轻，然而，严重霍乱的特点是剧烈的腹泻和呕吐，导致严重脱水。如果不及时使用抗生素和补液治疗，它将对患者的生命构成严重威胁。根据世界卫生组织资料显示，引起霍乱全球流行的主要致病菌为血清群O1霍乱弧菌。
FDA生物制品评价和研究中心主任Peter Marks博士说：“Vaxchora疫苗获批是对目前疾病预防控制中心推荐的霍乱流行区旅行者霍乱预防措施的有力补充。" 在美国，尽管霍乱比较罕见，但出游旅行者仍然可能因水资源匮乏、污水处理问题及卫生条件差等原因而存在感染霍乱的风险。旅行者前往霍乱疫区依赖的是美国CDC制定的霍乱自我防控措施，包括了制作安全的食用水和食物，并经常洗手。 至少在进入霍乱疫区10天前，旅行者就需要提前口服约3盎司的霍乱减毒活疫苗液剂。
Vaxchora的有效性在一项197名18-45岁美国志愿者随机安慰剂对照的人体试验中得到证实。197名志愿者中，68名Vaxchora服用者和66名安慰剂服用者分别口服霍乱弧菌，以观察感染霍乱的情况。结果显示，口服Vaxchora疫苗后的10天后的保护率达到90%，3个月后的保护率仍有80%。该研究还包括对有症状受试者进行抗生素和补液治疗。为了防止霍乱在社区传播，该研究也要求无症状受试者使用抗生素。 分别在美国和澳大利亚的18-64岁成年人中进行了两项评估免疫系统对该疫苗反应的安慰剂对照研究。在18-45岁年龄组中，93%的Vaxchora疫苗服用者产生了预防霍乱的保护性抗体。在46-64岁年龄组中，90%的Vaxchora疫苗服用者产生了预防霍乱的保护性抗体。但生活在霍乱疫区人群的Vaxchora疫苗保护率尚未确定。 Vaxchora的安全性评估在四个随机安慰剂对照多中心临床试验中开展，18-64岁成年人作为研究对象，其中3235位参与者服用Vaxchora疫苗，562位参与者服用安慰剂。Vaxchora疫苗服用者最常见的不良反应包括疲劳、头痛、腹痛、恶心/呕吐、食欲不振和腹泻。 美国食品药物管理局（FDA）通过快速通道优先审批了Vaxchora疫苗，这些区别对待旨在促进和加快危重疾病医疗产品的开发和审查程序。此外，根据2007年食品药品管理局修正法案的规定，FDA还将授予Vaxchora制造商热带病优先审查凭证，这一规定旨在鼓励并支持为某些热带疾病的预防和治疗研发新的药品和生物制品。 Vichora疫苗由PaxVax百慕大有限公司制造的，该公司位于百慕大汉密尔顿。 美国FDA隶属于美国国务院保健与服务部的公共健康服务署，旨在确保人畜药物、疫苗以及其他人类使用的生物制剂的安全性和有效性，还包括医疗器械的安全和有效。该机构还负责我国的食品供应、化妆品使用、食品添加剂、电子辐射产品的安全，并监管烟草制品。 原文附录如下
Release The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera. Cholera, a disease caused by Vibrio cholerae bacteria, is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe. Often the infection is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization, serogroup O1 is the predominant cause of cholera globally. “The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. While cholera is rare in the U.S., travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. Travelers to cholera-affected areas have relied on preventive strategies recommended by the CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing. Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area. Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers from 18 through 45 years of age. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80 percent among those challenged three months after vaccination. The study included provisions for administration of antibiotics and fluid replacement in symptomatic participants. To prevent transmission of cholera into the community, the study included provisions for administration of antibiotics to participants not developing symptoms. Two placebo-controlled studies to assess the immune system’s response to the vaccine were also conducted in the U.S. and Australia in adults 18 through 64 years of age. In the 18 through 45 year age group, 93 percent of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46 through 64 years age group, 90 percent produced antibodies indicative of protection against cholera. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas. The safety of Vaxchora was evaluated in adults 18 through 64 years of age in four randomized, placebo-controlled, multicenter clinical trials; 3,235 study participants received Vaxchora and 562 received a placebo. The most common adverse reactions reported by Vaxchora recipients were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea. The FDA granted the Vaxchora application fast track designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of medical products that address a serious or life-threatening condition. In addition, the FDA awarded the manufacturer of Vaxchora a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases. Vaxchora is manufactured by PaxVax Bermuda Ltd., located in Hamilton, Bermuda. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
原文来源：http://www.fda.gov/NewsEvents/Ne ... ments/ucm506305.htm
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发表于 2016-6-17 22:40
发表于 2016-6-23 22:47
