53 Participants Needed

PanChol Vaccine for Cholera

LB
Overseen ByLindsey Baden, MD
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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, and3. 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.

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.12345

What data supports the effectiveness of the PanChol Vaccine for cholera?

Research on similar oral cholera vaccines, like Shanchol, shows they can provide significant protection against cholera, with one study indicating 65% protection over five years. This suggests that vaccines like PanChol could also be effective in preventing cholera.34678

Are You a Good Fit for This Trial?

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 considered healthy based on my recent medical exams and history.
I am not pregnant or breastfeeding, and if of childbearing age, I am using effective birth control.

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 16 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • PanChol
Trial Overview The 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Fixed Dose-RangingExperimental Treatment1 Intervention
Group II: Adaptive Dose-finding/OptimizationExperimental Treatment1 Intervention
Group III: Expansion module - active productActive Control1 Intervention
Group IV: Expansion module - placeboPlacebo Group1 Intervention

PanChol is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as PanChol for:
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Approved in United States as PanChol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Published Research Related to This Trial

In a matched case-control study in Guinea involving 40 cholera cases and 160 controls, the two-dose Shanchol vaccine demonstrated significant short-term effectiveness, providing 86.6% protection against cholera after adjustment for confounding factors.
The results support the use of Shanchol as part of integrated responses to cholera outbreaks and highlight the importance of establishing a cholera vaccine stockpile for emergency situations.
Use of Vibrio cholerae vaccine in an outbreak in Guinea.Luquero, FJ., Grout, L., Ciglenecki, I., et al.[2022]
The oral cholera vaccine Shanchol demonstrated a protective effectiveness of 69% against cholera for individuals receiving two doses, which aligns with previous clinical trial results, indicating its efficacy in real-world settings.
The study, conducted in a cholera-endemic area of India, involved over 31,000 residents and showed that even a single dose of the vaccine provided some protection (33%), supporting its use in public health campaigns.
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.
Antibody Secreting Cell Responses following Vaccination with Bivalent Oral Cholera Vaccine among Haitian Adults.Matias, WR., Falkard, B., Charles, RC., et al.[2021]

Citations

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]
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