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.
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.
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.
Parallel
PanChol
Biological/VaccinePanchol 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.
vaccine safety
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination
immunogenicity
The seroconversion (4-fold rise titer over baseline) of the vibriocidal titers to both Inaba and Ogawa V. cholerae between pre- and post-vaccination with PanChol.
vaccine stool shedding
Stool shedding of PanChol organisms using quantitative and qualitative stool cultures
exploratory- serum antibody changes
Changes of IgG, IgA, and IgM antibodies targeting Inaba- and Ogawa-specific polysaccharides, CT-B and TCP.
exploratory- IgA and IgG secreting cell responses
Changes of IgA- and IgG-antibody secreting cell responses (ALS/plasmablast responses) and the memory B cell (MBC) response.
Exploratory- Microbiome modification
Stool microbiota modification according to 16S rRNA sequencing and/or metagenomic sequencing
Click on the lead sponsor to view all of their trials.