PanChol Vaccine for Cholera
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Brigham and Women's Hospital
Must not be taking: Immunosuppressants, Antibiotics, Tetracyclines, Aminoglycosides
Disqualifiers: Immunosuppressive condition, GI disorder, Cholera history, others
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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. a placebo-controlled expansion module.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've used systemic antibiotics within a month before the trial or received certain vaccines recently.
What data supports the effectiveness of the PanChol Vaccine for cholera?
How is the PanChol Vaccine for cholera different from other treatments?
The PanChol Vaccine for cholera is unique because it is a new treatment option, whereas existing vaccines like Shanchol and Dukoral are already used to prevent cholera. Unlike these existing vaccines, PanChol may offer a different mechanism of action, administration route, or formulation, but specific details are not provided in the available research.12678
Research Team
Eligibility Criteria
Healthy adults aged 18-55 can join this trial. They must be in good health based on medical checks, agree to stay in the hospital when needed, and use reliable contraception or abstain from sex if they can have children. People with immune issues, recent GI illness, previous cholera vaccine or infection, abnormal stool patterns, allergies to PanChol/placebo ingredients, recent antibiotic use or vaccines cannot join.Inclusion Criteria
Understanding and agreeing to comply with the study protocol including the inpatient period
I am between 18 and 55 years old and healthy.
I am considered healthy based on my recent medical exams and history.
See 1 more
Exclusion Criteria
I have not had a fever or stomach illness in the last week.
I haven't taken any antibiotics in the last month.
I regularly use laxatives.
See 17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single dose of PanChol or placebo and are monitored as inpatients for safety and sample collection
7 days
Inpatient stay at BWH
Follow-up
Participants are monitored for general health, adverse events, immune responses, and fecal microbiota composition
180 days
Visits on days 15, 29, 57, and 180
Extension
Optional continuation for further monitoring and data collection
Treatment Details
Interventions
- PanChol (Virus Therapy)
Trial OverviewThe study is testing a new cholera vaccine called PanChol. It's done in three parts: figuring out the right dose range; finding the best dose; and comparing it with a placebo (a treatment with no active drug). Volunteers will get either PanChol or placebo to check for safety and how well their bodies respond.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Fixed Dose-RangingExperimental Treatment1 Intervention
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).
Group II: Adaptive Dose-finding/OptimizationExperimental Treatment1 Intervention
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.
Group III: Expansion module - active productActive Control1 Intervention
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).
Group IV: Expansion module - placeboPlacebo Group1 Intervention
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).
PanChol is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as PanChol for:
- Prevention of cholera
🇺🇸 Approved in United States as PanChol for:
- Prevention of cholera
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's Hospital Vaccine UnitBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Trials
1694
Patients Recruited
14,790,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Use of Vibrio cholerae vaccine in an outbreak in Guinea.Luquero, FJ., Grout, L., Ciglenecki, I., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effectiveness of an oral cholera vaccine campaign to prevent clinically-significant cholera in Odisha State, India.Wierzba, TF., Kar, SK., Mogasale, VV., et al.[2022]
The bivalent whole-cell oral cholera vaccine (Shanchol) effectively induced significant mucosal immune responses, as evidenced by increased antibody secreting cells (ASCs) specific to V. cholerae O1 antigens in 24 Haitian adults after the first dose.
The second dose of the vaccine did not significantly boost ASC responses, indicating that the current two-dose schedule may not be optimal for enhancing mucosal immunity in adults living in cholera-endemic regions.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antibody Secreting Cell Responses following Vaccination with Bivalent Oral Cholera Vaccine among Haitian Adults.Matias, WR., Falkard, B., Charles, RC., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Development of oral vaccines against cholera and enterotoxinogenic Escherichia coli diarrhea.Holmgren, J., Svennerholm, AM.[2006]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial.Shah, S., Nandy, RK., Sethi, SS., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age.Saha, A., Chowdhury, MI., Khanam, F., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants.Saha, A., Khan, A., Salma, U., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vaccination strategies to combat an infectious globe: oral cholera vaccines.López-Gigosos, RM., Plaza, E., Díez-Díaz, RM., et al.[2021]
References
Use of Vibrio cholerae vaccine in an outbreak in Guinea. [2022]
Effectiveness of an oral cholera vaccine campaign to prevent clinically-significant cholera in Odisha State, India. [2022]
Antibody Secreting Cell Responses following Vaccination with Bivalent Oral Cholera Vaccine among Haitian Adults. [2021]
Development of oral vaccines against cholera and enterotoxinogenic Escherichia coli diarrhea. [2006]
Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial. [2023]
Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. [2022]
The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants. [2022]
Vaccination strategies to combat an infectious globe: oral cholera vaccines. [2021]