Can a genetically modified oral vaccine beat cholera?
NCT ID NCT07107516
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests a new oral cholera vaccine called PanChol in healthy adults aged 18 to 55 in Zambia. The vaccine is designed to be safer and more effective than current options. Researchers will monitor participants for side effects and measure their immune response after vaccination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a novel live attenuated oral cholera vaccine called PanChol
- What this could lead to
- If successful, PanChol could offer a more effective way to prevent cholera, a severe diarrheal disease that can be fatal within hours.
- What could go wrong
- This is an early Phase 1 trial with only 32 participants, so the vaccine may not prove safe or effective in larger studies. Side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Healthy adults aged from 18 to 55 years old. 3. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history. 4. Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period. 5. Female participants must be non-pregnant and non-lactating and either 1. 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) 2. 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) Exclusion Criteria: 1. 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. 2. Pregnant or lactating women. 3. 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. 4. Acute GI or febrile illness within 7 days of enrollment. 5. 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. 6. History of cholera vaccination. 7. History of cholera infection. 8. Abnormal stool pattern, defined as \< 3 or \>21 stools per week. 9. Allergy or intolerance to PanChol or placebo component (sodium bicarbonate, lactose, ascorbic acid) 10. Use of any systemic antibiotics within 1 month of PanChol administration. 11. Receipt of a live vaccine in the previous 4 weeks or planned in the 4 weeks following enrollment. 12. Receipt of a killed or subunit (non-live) vaccine in the previous 2 weeks or planned in the 2 weeks following enrollment. 13. Individuals who do not speak English 14. Childcare workers with direct contact with children ≤ 2 years of age 15. Individuals whose occupation involves handling of food 16. Healthcare workers who have direct contact with patients who are immunodeficient, HIV-positive, or have an unstable medical condition 17. Use laxatives regularly 18. Have diarrhea within 48 hours before enrollment 19. Have a history of hypersensitivity to any of the tetracyclines 20. Have a history of hypersensitivity to streptomycin or any aminoglycoside due to the known cross-sensitivity of patients to drugs in this class. 21. Individuals who have a household member who are immunodeficient, HIV-positive, or have an unstable medical condition.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CIDRZ Matero clinical reseach site
RECRUITINGLusaka, Lusaka Province, 10101, Zambia
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