PanChol Vaccine for Cholera
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
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of PanChol or placebo and are monitored as inpatients for safety and sample collection
Follow-up
Participants are monitored for general health, adverse events, immune responses, and fecal microbiota composition
Extension
Optional continuation for further monitoring and data collection
Treatment Details
Interventions
- PanChol (Virus Therapy)
PanChol is already approved in European Union, United States for the following indications:
- Prevention of cholera
- Prevention of cholera