NCT07107516招募中1 期
Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults
Centre for Infectious Disease Research in Zambia2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年5月20日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- vaccine safety
研究概览
简要总结
Cholera is a serious diarrheal disease that can be fatal within hours of onset. The current available cholera vaccines to prevent the disease are not very effective. Panchol is a new oral cholera vaccine that may be an improvement over the currently available vaccines in use. The goal of this study is to learn safety of this new oral cholera vaccine and the body's immune response to the vaccine.
The researchers will compare the PanChol vaccine to placebo to see the side effects experienced in participants.
The participants will be adults aged between 18 and 55 years and they will be required to:
- Be admitted to hospital until they stop passing the cholera vaccine in their stool. During admission, all side effects will be recorded by the researchers.
- After discharge, the participants will visit the research site every month for 3 months with an optional visit at the 4th month for the researchers to assess the participants' general health.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent (signed and dated) and any other authorizations required by local law and be able to comply with all study requirements.
- •Healthy adults aged from 18 to 55 years old.
- •Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.
- •Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period.
- •Female participants must be non-pregnant and non-lactating and either
- •surgically sterile (history of bilateral ligation, bilateral salpingectomy, bilateral oophorectomy, total hysterectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)
- •be of child-bearing potential and practicing an acceptable method of contraception or abstaining from all activities that could result in pregnancy for at least 28 days before vaccination until 3 months after receiving the investigational product.
- •Acceptable methods of contraception include barrier methods (such as condom, diaphragm, or cervical cap used in conjunction with spermicide), intrauterine device, hormonal contraception (that may be taken or administered by oral, intravaginal, transdermal, subdermal or IM route), vasectomized partner (the vasectomized partner should be the sole partner for that participant)
排除标准
- •Confirmed or suspected immunosuppressive condition, as a result of a disease (e.g., primary immune deficiency, malignancy, HIV infection) or have taken any systemic immunosuppressive therapy within 6 months of enrollment.
- •Pregnant or lactating women.
- •History of gastrointestinal (GI) disorder, such as previous major GI surgery, malabsorption, or any chronic GI disorders that would interfere, according to the investigator, with the IP.
- •Acute GI or febrile illness within 7 days of enrollment.
- •Have any acute or chronic medical condition that, in the opinion of the investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- •History of cholera vaccination.
- •History of cholera infection.
- •Abnormal stool pattern, defined as < 3 or >21 stools per week.
- •Allergy or intolerance to PanChol or placebo component (sodium bicarbonate, lactose, ascorbic acid)
- •Use of any systemic antibiotics within 1 month of PanChol administration.
- •Receipt of a live vaccine in the previous 4 weeks or planned in the 4 weeks following enrollment.
- •Receipt of a killed or subunit (non-live) vaccine in the previous 2 weeks or planned in the 2 weeks following enrollment.
- •Individuals who do not speak English
- •Childcare workers with direct contact with children ≤ 2 years of age
- •Individuals whose occupation involves handling of food
- •Healthcare workers who have direct contact with patients who are immunodeficient, HIV-positive, or have an unstable medical condition
- •Use laxatives regularly
- •Have diarrhea within 48 hours before enrollment
- •Have a history of hypersensitivity to any of the tetracyclines
- •Have a history of hypersensitivity to streptomycin or any aminoglycoside due to the known cross-sensitivity of patients to drugs in this class.
- •Individuals who have a household member who are immunodeficient, HIV-positive, or have an unstable medical condition.
研究组 & 干预措施
cohort 2b
Experimental
The PanChol vaccine will be given at a dose of 2 x 10^8 CFU in this arm
干预措施: PanChol (Biological)
cohort 2a
Experimental
The PanChol vaccine will be given at a dose of 2 x 10^7 CFU in this arm
干预措施: PanChol (Biological)
结局指标
主要结局
vaccine safety
时间窗: 14 days after vaccination
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination
次要结局
- vaccine stool shedding(8 days after vaccination)
- immunogenicity(180 days after vaccination)
- immunogenicity(180 days after vaccination)
- vaccine stool shedding(8 days after vaccination)
研究者
研究点 (2)
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