A Phase 2 Randomized, Double-Blinded Study to Compare in Malian Adults the Immunogenicity, Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units [Cfu] or 109 Cfu Using Shanchol™ Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination
研究概览
简要总结
To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline.
To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.
详细描述
Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® [Crucell; Leiden, The Netherlands] and Shanchol™ [Shantha Biotechnics; Hyderabad, India]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose.
This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10^8 cfu versus the 10^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.
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
- Triple (Participant, 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
- •Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages [Bambara and French] followed by making a mark and signature by a literate witness)
- •Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
- •Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
- •Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose
排除标准
- •Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
- •Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
- •History of an abnormal stool pattern or regular use of laxatives
- •Previously received a licensed or investigational cholera vaccine
- •History of cholera illness
研究组 & 干预措施
PXVX0200 10E8 then placebo
PXVX0200 10E8 on day 0; Placebo on day 14
干预措施: Placebo (Biological)
Placebo, then PXVX0200 10E8
Placebo on day 0; PXVX0200 10E8 on day 14
干预措施: PXVX0200 10E8 (Biological)
PXVX0200 10E8 then placebo
PXVX0200 10E8 on day 0; Placebo on day 14
干预措施: PXVX0200 10E8 (Biological)
Placebo, then PXVX0200 10E8
Placebo on day 0; PXVX0200 10E8 on day 14
干预措施: Placebo (Biological)
PXVX0200 10E9 then Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
干预措施: PXVX0200 10E9 (Biological)
PXVX0200 10E9 then Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
干预措施: Placebo (Biological)
Placebo then PXVX0200 10E9
Placebo on day 0; PXVX0200 10E9 on day 14
干预措施: PXVX0200 10E9 (Biological)
Placebo then PXVX0200 10E9
Placebo on day 0; PXVX0200 10E9 on day 14
干预措施: Placebo (Biological)
Shanchol
Two doses of Shanchol, on day 0 and day 14
干预措施: Shanchol (Biological)
结局指标
主要结局
To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination
时间窗: 14 days
A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (\> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline
次要结局
- To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine(14 days)
- To plot the kinetics of the serum Inaba Vibriocidal antibody response(Baseline and post-vaccination time point.)
- Assess fecal shedding of PXVX0200(Day 1-3, day 7 and day 14)
- Compare rate of diarrhea(7 days)
研究者
Milagritos Tapia
Assistant Professor
University of Maryland, Baltimore