Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers

Официальное название

Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults

Обзор

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: 1. 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. 2. 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.

Вмешательства

• Биопрепарат PanChol
  Panchol is a novel live attenuated oral cholera vaccine. It is the first vaccine created with the variant El Tor background that is predominant in the world today. The vaccine has ten different genetic modifications to minimize reactogenicity but maintain the ability to colonize the intestine.

Первичные конечные точки

• vaccine safety [Срок оценки: 14 days after vaccination]

Вторичные конечные точки (2)

• immunogenicity [Срок оценки: 180 days after vaccination]
• vaccine stool shedding [Срок оценки: 8 days after vaccination]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Zambia · 1 центр

• CIDRZ Matero clinical reseach site — Lusaka

Идентификаторы

NCT: NCT07107516 · PanChol 101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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