Cholera Clinical Trial - First in Human Phase 1 Ascending Dose Study of

Status Recruiting

Clinical 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. a placebo-controlled expansion module.

Clinical Trial 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

Related Conditions & MeSH terms

Cholera

Clinical Trial Details

NCT number	NCT05657782
Study type	Interventional
Source	Brigham and Women's Hospital
Contact	Lindsey Baden, MD
Phone	617-525-8418
Email	lbaden@bwh.harvard.edu
Status	Recruiting
Phase	Phase 1
Start date	December 12, 2022
Completion date	December 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01895855` - Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera	Phase 3
Completed	`NCT01339845` - Introduction of Cholera Vaccine in Bangladesh	N/A
Recruiting	`NCT05829772` - Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence
Completed	`NCT04760236` - Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™	Phase 3
Recruiting	`NCT04326478` - Single Dose Azithromycin to Prevent Cholera in Children	Phase 2
Recruiting	`NCT06104345` - Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines	Phase 4
Completed	`NCT02928341` - Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo	N/A
Completed	`NCT02864433` - Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
Recruiting	`NCT06003816` - Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)	N/A
Not yet recruiting	`NCT05771779` - Co-administration Study of OCV, TCV and MR	Phase 3
Completed	`NCT04150250` - Cholera Anti-Secretory Treatment Trial	Phase 2
Terminated	`NCT00624975` - Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants	Phase 2
Completed	`NCT00226616` - Zinc Supplementation in Cholera Patients	Phase 3
Completed	`NCT03373669` - Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine	Phase 4
Completed	`NCT02100631` - A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults	Phase 3
Completed	`NCT02094586` - A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults	Phase 3
Completed	`NCT01823939` - PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera	Phase 1
Completed	`NCT01365442` - Pilot Introduction of Oral Cholera Vaccine in Orissa, India	N/A
Completed	`NCT00128011` - Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine	Phase 2
Completed	`NCT00672308` - Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms