Cholera Vaccination ReactionPhase 1PanCholNCT07107516
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
A Phase 1 study testing PanChol in people with Cholera Vaccination Reaction, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera Vaccination Reaction
- What is being tested?
- PanChol
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteZambia
- Study dates
- 20 May 2026to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site, 1 recruiting
- Recruiting
CIDRZ Matero clinical reseach site
Lusaka, Lusaka Province, 10101
Chikumbutso Chipeta, +260969810681, chikumbutso.chipeta@cidrz.org
About this study
Official title: Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults
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.
Read more
The participants will be adults aged between 18 and 55 years and they will be required to:
- 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.
- 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.
- Conditions
- Cholera Vaccination Reaction
- Being tested
- PanChol
- Keywords
- cholera, vaccine, safety
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanCholBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort 2a | Experimental | The PanChol vaccine will be given at a dose of 2 x 10^7 CFU in this arm Receives: Biological: PanChol |
| cohort 2b | Experimental | The PanChol vaccine will be given at a dose of 2 x 10^8 CFU in this arm Receives: Biological: PanChol |
| cohort 2c | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaccine safety
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination
Measured: 14 days after vaccination
Secondary outcomes (2)
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.
Measured: 180 days after vaccination
vaccine stool shedding
Stool shedding of PanChol organisms using quantitative and qualitative stool cultures
Measured: 8 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start20 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholera Vaccination ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107516
- Sponsor's protocol ID
- PanChol 101
- Acronym
- PanChol
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults
- ClinicalTrials.gov ID
- NCT07107516
- Acronym / sponsor ID
- PanChol / PanChol 101
- Conditions
- Cholera Vaccination Reaction
- Keywords
- cholera, vaccine, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 2a | Experimental | Biological: PanCholThe PanChol vaccine will be given at a dose of 2 x 10^7 CFU in this arm |
| cohort 2b | Experimental | Biological: PanCholThe PanChol vaccine will be given at a dose of 2 x 10^8 CFU in this arm |
| cohort 2c | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanCholPanchol 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. | Biological | cohort 2a, cohort 2b |
Primary outcome
vaccine safety
Time frame: 14 days after vaccination
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination
2 secondary outcomes
immunogenicity
Time frame: 180 days after vaccination
vaccine stool shedding
Time frame: 8 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cholera Vaccination Reaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PanChol in people with Cholera Vaccination Reaction, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaccine safety (time frame: 14 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.