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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 2a | Experimental | The PanChol vaccine will be given at a dose of 2 x 10^7 CFU in this arm |
|
| cohort 2b | Experimental | The PanChol vaccine will be given at a dose of 2 x 10^8 CFU in this arm |
|
| cohort 2c | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PanChol | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| vaccine safety | The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination | 14 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days after vaccination |
| vaccine stool shedding |
| Measure | Description | Time Frame |
|---|---|---|
| exploratory- serum antibody changes | Changes of IgG, IgA, and IgM antibodies targeting Inaba- and Ogawa-specific polysaccharides, CT-B and TCP. | 180 days after vaccination |
| exploratory- IgA and IgG secreting cell responses |
Inclusion Criteria:
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
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)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDRZ Matero clinical reseach site | Lusaka | Lusaka Province | 10101 | Zambia |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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|
Stool shedding of PanChol organisms using quantitative and qualitative stool cultures
| 8 days after vaccination |
Changes of IgA- and IgG-antibody secreting cell responses (ALS/plasmablast responses) and the memory B cell (MBC) response.
| 180 days after vaccination |
| Exploratory- Microbiome modification | Stool microbiota modification according to 16S rRNA sequencing and/or metagenomic sequencing | 180 days after vaccination |
| D007239 | Infections |