Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02145377
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2014-05-20
Brief Title:
PXVX0200 CVD103-HgR vs Shanchol in Mali
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 2 Randomized Double-Blinded Study to Compare in Malian Adults the Immunogenicity Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 CVD 103-HgR Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units Cfu or 109 Cfu Using Shanchol Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator
Status:
COMPLETED
Status Verified Date:
2019-09
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:
To compare the ability of a single dose of PXVX0200 at two different dose levels to placebo to elicit a significant antibody response 14 days after vaccination compared to baseline
To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol a two dose administration to elicit antibody response by 14 days after vaccination
To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol a two dose administration to elicit antibody response by 14 days after vaccination
Detailed Description:
Currently there are two licensed inactivated vibrio oral vaccines Dukoral Crucell Leiden The Netherlands and Shanchol Shantha Biotechnics Hyderabad India that are pre-qualified by the World Health Organization WHO for procurement by United Nations UN agencies Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose
This Phase 2 randomized observer-blinded and subject-blinded clinical trial to be conducted in Bamako Mali will assess the immunogenicity of the 108 cfu versus the 109 cfu formulation of PaxVax-manufactured CVD 103-HgR
This Phase 2 randomized observer-blinded and subject-blinded clinical trial to be conducted in Bamako Mali will assess the immunogenicity of the 108 cfu versus the 109 cfu formulation of PaxVax-manufactured CVD 103-HgR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None