NCT01895855已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 6
- 主要终点
- % of Participants With Moderate to Severe Diarrhea
研究概览
简要总结
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
详细描述
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men or women,
- •age 18 to 45 years inclusive;
- •normal medical history and physical examination; and
- •no clinically significant abnormalities from:
- •urine dipstick for glucose, protein, and blood
- •complete blood count,
- •serum hepatic transaminases,
- •total bilirubin (direct if abnormal),
- •creatinine,
- •electrolytes,
- •albumin, or
- •electrocardiogram.
- •Women must have a negative pregnancy test.
排除标准
- •travel to a cholera endemic area in the previous 5 years;
- •abnormal stool pattern or regular use of laxatives;
- •history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
- •history of cholera or enterotoxigenic E. coli challenge or infection;
- •current or recent antibiotic use;
- •pregnancy or nursing;
- •positive serology for HIV, hepatitis B antigen, or hepatitis C;
- •any immunosuppressive medical condition;
- •history of hospitalization for psychiatric illness or use of specific psychiatric drugs.
结局指标
主要结局
% of Participants With Moderate to Severe Diarrhea
时间窗: Ninety days after vaccination
Determine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) of diarrhea.
次要结局
- % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge(Through 10 Days following challenge)
- # of Days With Positive Stool Culture Following 90 Day Cholera Challenge(Through 10 Days following challenge)
- % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge(Through 10 Days following challenge)
- Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge(Through 10 Days following challenge)
- # of Days With Positive Stool Culture Following 10 Day Cholera Challenge(Through 10 Days following challenge)
- % of Participants With Fever Following the 90 Day Cholera Challenge(Through 10 Days following challenge)
- Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge(Through 10 Days following challenge)
- % of Participants With Fever Following the 10 Day Cholera Challenge(Through 10 Days following challenge)
- Number of Days With Fecal Shedding Following 10 Day Challenge(Through 10 Days post challenge)
- Number of Days With Fecal Shedding Following 90 Day Challenge(Through 10 days following challenge)
- % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination(Following vaccination (Days 1 - 8) and to Day 29)
研究者
研究点 (6)
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