PanChol Vaccine for Cholera

Overseen By Lindsey Baden, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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 This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and immune response of a new cholera vaccine called PanChol in healthy adults. Researchers will explore different doses to find the most effective one, using a series of modules, including one with a placebo (inactive treatment) for comparison. Participants who are healthy, have no history of cholera infection or vaccination, and can follow the study's requirements are well-suited for this trial. As a Phase 1 trial, this research focuses on understanding how the new vaccine works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that the PanChol Vaccine is likely to be safe for humans?

Research shows that PanChol, a new pill vaccine for cholera, prioritizes safety. Earlier studies found it to be safe and stable. In initial tests, no serious side effects have been reported. However, PanChol remains in the early testing phase and lacks FDA approval. This trial marks its first testing in humans, and more information will be gathered as the trial progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike existing cholera vaccines, PanChol is being explored with cutting-edge dosing strategies to optimize its effectiveness and minimize side effects. Researchers are using innovative designs like fixed dose-ranging and adaptive dose-finding to precisely determine the best dose, which could potentially lead to a safer and more effective vaccine. This tailored approach is exciting because it could result in a vaccine that offers better protection with fewer adverse effects than current options.

What evidence suggests that the PanChol Vaccine might be an effective treatment for cholera?

Research has shown that the PanChol vaccine looks promising in early studies. In animal tests, it was safe and helped the body create antibodies to fight cholera. Some studies have found that similar vaccines protect about 55% of the time, although this protection might decrease over time. This trial will evaluate PanChol in different treatment arms, including a placebo-controlled group, to determine its safety and effectiveness. PanChol aims to improve on existing vaccines by possibly offering better protection with just one dose. Early results suggest it is safe and effectively helps the body defend against cholera. ^{1 2 3 4 6}

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.

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?

Group I: Fixed Dose-Ranging Experimental Treatment 1 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/Optimization Experimental Treatment 1 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 product Active Control 1 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 - placebo Placebo Group 1 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

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

The oral cholera vaccine Shanchol was found to be safe, with no major adverse events reported across all age groups (adults, toddlers, and younger children) in a double-blind, randomized placebo-controlled study.

Immunogenicity results showed strong vibriocidal antibody responses, particularly in toddlers (84% against Vibrio cholerae O1 Inaba), indicating that Shanchol effectively stimulates the immune system and supports its potential for use in cholera-endemic regions.

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]

The oral cholera vaccine Shanchol™ remains safe and effective even when stored at elevated temperatures (up to 42°C) for 14 days, as shown in a study with 580 adult participants across four groups.

All groups demonstrated significant immune responses to the vaccine, with no major differences in safety or immunogenicity, suggesting that Shanchol™ can be distributed more easily in resource-poor settings without the need for strict cold chain storage.

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]

The oral cholera vaccine, which includes a nontoxic B subunit of cholera toxin and killed cholera vibrios, has been shown to provide effective protection against cholera for at least 3 years without any side effects, based on extensive clinical trials.

This vaccine also offers some protection against diarrhea caused by enterotoxinogenic E. coli (ETEC), and advancements in recombinant DNA techniques suggest that a new effective oral ETEC vaccine may soon be developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of oral vaccines against cholera and enterotoxinogenic Escherichia coli diarrhea. Holmgren, J., Svennerholm, AM.[2006]

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.

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]

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.

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]

Cholera remains a significant health issue in Africa and Asia, with two effective oral vaccines available: Dukoral, which offers additional short-term protection against E. coli, and Shanchol, both recommended for use in endemic areas and for travelers.

The systematic review of vaccine efficacy and acceptance supports the use of these vaccines in cholera-affected populations, highlighting their importance in preventing outbreaks and protecting at-risk individuals.

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]

Euvichol-Plus demonstrated non-inferior immunogenicity compared to Shanchol, with 68.93% of participants showing a significant increase in antibodies against cholera after vaccination, indicating it is an effective alternative vaccine.

The safety profile of Euvichol-Plus was comparable to Shanchol, with headache being the most common side effect, suggesting it is a safe option for both adults and children in India.

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]

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]

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Healthy Volunteers Wanted for a Cholera Vaccine Study

In animals, this vaccine has been shown to be safe and able to protect (make antibodies) against cholera. PanChol, the product to be used in this study, is not ...

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sciety-labs.elifesciences.org/articles/by?article_doi=10.1101/2025.09.12.25335655

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PanChol's favorable safety profile and immunogenicity support additional development as a new agent for cholera control. Since PanChol is ...

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This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers.