Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05657782
Status:
RECRUITING
Last Update Posted:
2022-12-20
First Post:
2022-11-12
Brief Title:
First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
PanChol-100 Safety and Immunogenicity of PanChol First-in-Human Study of a Novel Live Attenuated Oral Cholera Vaccine
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-findingoptimization module and
3 a placebo-controlled expansion module
1 a fixed dose-ranging module
2 an adaptive dose-findingoptimization module and
3 a placebo-controlled expansion module
Detailed 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 ALSplasmablast responses andor 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 Womens 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
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 ALSplasmablast responses andor 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 Womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None