CholeraPhase 1NCT05657782
First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers
A Phase 1 study testing PanChol in people with Cholera and Cholera Vaccine Toxicity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity: 1. a fixed dose-ranging module, 2. an adaptive dose-finding/optimization module, and 3. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera, Cholera Vaccine Toxicity
- What is being tested?
- PanChol
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
- Understanding and agreeing to comply with the 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 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 IP.
- 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
- Each participant must not meet any of the following exclusion criteria to be eligible for enrollment in the study:
- 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.
Show all 21Show fewer
- History of cholera vaccination
- 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 will not be enrolled into this trial. This study involves more than minimal risk and no prospect of direct benefit for participants. Additionally, a subject who did not speak English may not be able to easily communicate safety concerns in a timely fashion to the study investigators
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital Vaccine Unit
Boston, Massachusetts, 02115
Lindsey Baden, MD, 617-525-7327, vaccines@partners.org
About this study
Official title: PanChol-100: Safety and Immunogenicity of PanChol: First-in-Human Study of a Novel Live Attenuated Oral Cholera Vaccine
This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity:
- a fixed dose-ranging module,
- an adaptive dose-finding/optimization module, and
- a placebo-controlled expansion module.
Read the detailed description
The primary objectives of this study are:
- To evaluate the reactogenicity and the safety of a single-dose PanChol over a range of doses in healthy volunteers.
- To evaluate the immunogenicity of a single-dose PanChol over a range of doses as measured by vibriocidal antibody titers.
The secondary objectives of this study are:
- To further characterize PanChol immune response, such as the magnitude of vibriocidal titers, the IgG, IgA, and IgM antibodies targeting Inaba- and Ogawa-specific polysaccharides, cholera toxin B subunit, and TCP, IgA- and IgG-antibody secreting cell responses (ALS/plasmablast responses) and/or the memory B cell (MBC) response.
- To characterize the stool shedding of the PanChol organisms after vaccination.
- To evaluate the changes of the gut microbiota after PanChol vaccination and to compare these changes with cholera-induced changes on microbiota
Participants will be enrolled at the Brigham and Women's Hospital (BWH). For the first days of the trial, participants will be inpatients in BWH, for optimal safety monitoring and for fecal and blood samples collection. PanChol or placebo will be administered on Day 1. On Day 6, participants will be starting doxycycline to eradicate the shedding of the vaccine organisms. On Day 7, those who are no longer excreting PanChol in their stool will be discharged. After discharge, volunteers will return on days 15, 29, 57, and 180 for monitoring of general health, AE assessment, immune responses, and fecal microbiota composition. Approximately 53 adult healthy volunteers are planned to be enrolled in this study if all planned treatment groups are conducted.
- Conditions
- Cholera, Cholera Vaccine Toxicity
- Being tested
- PanChol
- Keywords
- cholera, vaccine, safety, immunogenicity
- 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 new second generation live-attenuated oral cholera vaccine (OCV) that circumvents limitations of previous live-attenuated OCVs. In contrast to other live OCVs, PanChol is derived from a current circulating pandemic V. cholerae strain, thus eliminating the risk of vaccine-derived genes from extinct V. cholerae strains (such as CVD 103-HgR) recombining with circulating V. cholerae strains.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose-Ranging | Experimental | The first, fixed dose-ranging module utilizes a classical "3+3 design". The name is derived from the typical cohort size at a given dose [3], and the typical expansion size at that dose [3] if 1 dose-limiting side effect is observed. This module will address the uncertainty regarding the relationship between dose and adverse events (AEs). A set of pre-specified doses (log10 values 6, 7, 8, 9, and 10) will be employed, based on animal experiments and other live OCV trials. Three participants will be administered each dose (15 participants total). Receives: Biological: PanChol |
| Adaptive Dose-finding/Optimization | Experimental | A modified continual reassessment method (CRM) adaptive design will guide the dose optimization module. CRM cohorts comprise 3 participants treated concurrently at each dose. All three subjects in each cohort will receive a single dose based on the CRM model fit to all the available dose-response data. Receives: Biological: PanChol |
| Expansion module - active product | Active comparator | The purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total). Receives: Biological: PanChol |
| Expansion module - placebo | Placebo comparator | The purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total). Receives: Biological: PanChol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination.
Measured: 180 days
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
Secondary outcomes (2)
The magnitude of pre- and post-vaccination serum vibriocidal titers to both Inaba and Ogawa V. cholerae.
Measured: 180 days
The stool shedding of PanChol organisms using stool cultures.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start12 Dec 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsey R. Baden, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657782
- Sponsor's protocol ID
- PanChol-100
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Leitner DR, Walsh SR, Suzuki M, Desjardins M, Hannaford A, Sherman AC, Levine H, Carr L, Hammerness E, Osaki A, Sullivan E, Wang B, Balazs GI, Park Chang JB, Slater DM, Puri N, Kuehl CJ, Chen WH, Harris JB, Piantadosi S, Baden LR, Waldor MK; PanChol study group. Safety and immunogenicity of PanChol, a single-dose live-attenuated oral cholera vaccine: results from a phase 1a, double-blind, randomised, placebo-controlled trial. Lancet Infect Dis. 2026 May;26(5):497-509. doi: 10.1016/S1473-3099(25)00682-6. Epub 2026 Jan 7.
PubMed 41519137
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PanChol-100: Safety and Immunogenicity of PanChol: First-in-Human Study of a Novel Live Attenuated Oral Cholera Vaccine
- ClinicalTrials.gov ID
- NCT05657782
- Acronym / sponsor ID
- PanChol-100
- Conditions
- Cholera, Cholera Vaccine Toxicity
- Keywords
- cholera, vaccine, safety, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Dec 2022 (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.
This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity:
- a fixed dose-ranging module,
- an adaptive dose-finding/optimization module, and
- a placebo-controlled expansion module.
Detailed description
The primary objectives of this study are:
- To evaluate the reactogenicity and the safety of a single-dose PanChol over a range of doses in healthy volunteers.
- To evaluate the immunogenicity of a single-dose PanChol over a range of doses as measured by vibriocidal antibody titers.
The secondary objectives of this study are:
- To further characterize PanChol immune response, such as the magnitude of vibriocidal titers, the IgG, IgA, and IgM antibodies targeting Inaba- and Ogawa-specific polysaccharides, cholera toxin B subunit, and TCP, IgA- and IgG-antibody secreting cell responses (ALS/plasmablast responses) and/or the memory B cell (MBC) response.
- To characterize the stool shedding of the PanChol organisms after vaccination.
- To evaluate the changes of the gut microbiota after PanChol vaccination and to compare these changes with cholera-induced changes on microbiota
Participants will be enrolled at the Brigham and Women's Hospital (BWH). For the first days of the trial, participants will be inpatients in BWH, for optimal safety monitoring and for fecal and blood samples collection. PanChol or placebo will be administered on Day 1. On Day 6, participants will be starting doxycycline to eradicate the shedding of the vaccine organisms. On Day 7, those who are no longer excreting PanChol in their stool will be discharged. After discharge, volunteers will return on days 15, 29, 57, and 180 for monitoring of general health, AE assessment, immune responses, and fecal microbiota composition. Approximately 53 adult healthy volunteers are planned to be enrolled in this study if all planned treatment groups are conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose-Ranging | Experimental | Biological: PanCholThe first, fixed dose-ranging module utilizes a classical "3+3 design". The name is derived from the typical cohort size at a given dose [3], and the typical expansion size at that dose [3] if 1 dose-limiting side effect is observed. This module will address the uncertainty regarding the relationship between dose and adverse events (AEs). A set of pre-specified doses (log10 values 6, 7, 8, 9, and 10) will be employed, based on animal experiments and other live OCV trials. Three participants will be administered each dose (15 participants total). |
| Adaptive Dose-finding/Optimization | Experimental | Biological: PanCholA modified continual reassessment method (CRM) adaptive design will guide the dose optimization module. CRM cohorts comprise 3 participants treated concurrently at each dose. All three subjects in each cohort will receive a single dose based on the CRM model fit to all the available dose-response data. |
| Expansion module - active product | Active comparator | Biological: PanCholThe purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total). |
| Expansion module - placebo | Placebo comparator | Biological: PanCholThe purpose of the expansion cohort is to gather additional clinical experience at the optimal dose of PanChol and increase the precision with which the rate of AEs is estimated. The expansion module will be randomized, double blind and placebo-controlled (20 receiving active product, 6 receiving placebo, 26 participants total). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- Understanding and agreeing to comply with the 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).
Key exclusion criteria (21 listed)
- Each participant must not meet any of the following exclusion criteria to be eligible for enrollment in the study:
- 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.
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 new second generation live-attenuated oral cholera vaccine (OCV) that circumvents limitations of previous live-attenuated OCVs. In contrast to other live OCVs, PanChol is derived from a current circulating pandemic V. cholerae strain, thus eliminating the risk of vaccine-derived genes from extinct V. cholerae strains (such as CVD 103-HgR) recombining with circulating V. cholerae strains. | Biological | Adaptive Dose-finding/Optimization, Expansion module - active product, Expansion module - placebo, Fixed Dose-Ranging |
Primary outcome
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination.
Time frame: 180 days
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.
Time frame: 180 days
2 secondary outcomes
The magnitude of pre- and post-vaccination serum vibriocidal titers to both Inaba and Ogawa V. cholerae.
Time frame: 180 days
The stool shedding of PanChol organisms using stool cultures.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 41519137Leitner DR, Walsh SR, Suzuki M, Desjardins M, Hannaford A, Sherman AC, Levine H, Carr L, Hammerness E, Osaki A, Sullivan E, Wang B, Balazs GI, Park Chang JB, Slater DM, Puri N, Kuehl CJ, Chen WH, Harris JB, Piantadosi S, Baden LR, Waldor MK; PanChol study group. Safety and immunogenicity of PanChol, a single-dose live-attenuated oral cholera vaccine: results from a phase 1a, double-blind, randomised, placebo-controlled trial. Lancet Infect Dis. 2026 May;26(5):497-509. doi: 10.1016/S1473-3099(25)00682-6. Epub 2026 Jan 7.
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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. This study is not recruiting at the moment.
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 and Cholera Vaccine Toxicity, run by Brigham and Women's Hospital at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Dec 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Baden, MD (617-525-8418, lbaden@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of solicited and unsolicited adverse events, including serious adverse events, following PanChol vaccination. (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657782, which also lists 1 linked publication.
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 20 Dec 2022.