About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PanChol