2016年6月10日,美国食品和药品监管局(FDA)批准Vaxchora，一种疫苗为预防血清型O1所致霍乱在至霍乱-受影响地区旅行18至64岁成年。Vaxchora是唯一被FDA-批准为预防霍乱的疫苗。
霍乱，是被Vibrio 霍乱细菌所致的疾病，是通过摄入被污染的水或食物和致水样腹泻其范围从轻度至极严重。但是感染往往是轻度;严重霍乱的特征是大量腹泻和呕吐，导致脱水。它是潜在地危及生命如果不能及时开始用抗菌素和液体替代治疗。按照世界卫生组织，血清型O1 是全球霍乱主要病因。
FDA的生物制品评价和研究中心主任Peter Marks，M.D.，Ph.D.说：“The approval of Vaxchora的批准代表疾病控制和预防中心当前对霍乱受影响地区旅行者重要增添推荐霍乱-预防措施。”。
而霍乱在美国是罕见的，去有不适当水和污水处理以及卫生条件差旅行者是处于感染风险。去霍乱-受影响地区的旅行者应依靠美国疾病预防和控制中心(CDC)推荐的预防霍乱策略保护他们自己，包括安全食物和水实践以及频繁洗手。
Vaxchora是一活，减弱疫苗去霍乱-受影响地区旅行前至少10天用作为一种单次，口服液体剂量约三液体盎司。
在一项来自18至45岁197例美国志愿者随机化，安慰剂对照人Vaxchora挑战研究显示Vaxchora的效能。在197例志愿者中，68例Vaxchora接受者和66例安慰剂接受者用口服摄取致霍乱Vibrio霍乱细菌。接受免疫接种挑战后10天Vaxchora效能是90 %和接种后三个月80%。研究包括在有症状参加者给予抗菌素和液体替代的规定。为预防霍乱传播至社会，研究包括对未发生症状参加者给予抗菌素的规定。
在美国和澳大利亚还在18至64岁成年中进行两项安慰剂-对照研究评估免疫系统对疫苗的反应。在18至45岁年龄组，Vaxchora接受者93%产生抗体表明对霍乱保护。在46至64岁组，90%产生抗体指示对霍乱保护。尚未确定对霍乱-受影响地区生活人们Vaxchora的有效性。
在18至64岁成年4项随机化，安慰剂对照，多中心临床试验评价Vaxchora的安全性； 3,235例研究参加者接受Vaxchora和562例接受一种安慰剂。Vaxchora接受者报道的最常见不良反应是疲倦，头痛，腹痛，恶心/呕吐，厌食和腹泻。
FDA授予Vaxchora申请快速通道指定和优先水平状态。这些是意向促进和加快解决一种严重或危及生命情况医疗产品发展和审评的不同程序。此外，FDA包括在2007年美国食品和药品修正法案下一种规定奖励Vaxchora的制造商一种热带疾病优先审查凭证。这个规定目的是鼓励对预防和治疗某些热带病新药和生物制品的开发。
Vaxchora是位于百慕大汉密尔顿PaxVax Bermuda有限公司制造。
Vaxchora(cholera vaccine, live, oral)
Brand name: Vaxchora
Generic name: cholera vaccine, live, oral
Company: PaxVax Bermuda Ltd.
Treatment for: Cholera Prophylaxis
Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas.
New Drugs Online Report for PXVX0200
Information
Generic Name: PXVX0200  
Trade Name: Vaxchora 
Synonym: CVD 103-HgR 
Entry Type: New molecular entity  
Development and Regulatory status
UK: None 
EU: None 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Dec 14: PaxVax plans to file in the US in mid 2015 [4].
10/12/2014 17:56:10 
PXVX0200 has been granted Fast Track designation in the US [2].
06/12/2013 09:39:43 
Trial or other data
Dec 14: Paxvax´s cholera vaccine meets its primary outcome in a PIII trial designed to evaluate the safety and ability to induce an immune response of three consecutive lots of the vaccine candidate. In 3,000 subjects in the Australia and the U.S., each of the three lots met a pre-set immunological endpoint for consistency of manufacture [4].
10/12/2014 17:54:17
Jan 14: Interim data from a PIII cholera challenge study reported. In participants challenged at 10 days post vaccination with wild type, fully pathogenic cholera bacteria the rate of diarrhoea was reduced in the vaccine group: 20/33 participants who received placebo experienced moderate-to-severe diarrhoea vs 2/35 of 35 who received PXVX0200. A second, separate group of volunteers will be challenged at 90 days post vaccination to further evaluate duration of vaccine protection. The co-primary endpoint will combine both challenge time points [3].
10/01/2014 08:54:50
Dec 13: PaxVax has raised $22m which will be used to continue to fund the recently initiated PIII clinical trial program for PXVX0200 as a traveler´s vaccine. Approximately 3,000 participants will be enrolled in this pivotal international programme, which comprises cholera challenge, safety, and immunogenicity studies. Studies are being conducted in the US, Australia, and Canada [2]. 
06/12/2013 09:39:26
NCT01895855 is a PIII randomized, double-blind, placebo-controlled, trial of a single dose of PXVX0200 in preventing cholera following challenge with vibrio cholera O1 El Tor Inaba. The co-primary outcomes are protection afforded at 10 and at 90 days post-vaccination. The study plans to enrol 210 healthy volunteers aged 18-45 from Sep 13. Estimated date of study completion is Jul 14 [1].
06/12/2013 09:39:13
References  
Available only to registered users
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506305.htm