Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01129453
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2010-05-21
Brief Title:
Safety and Immunogenicity of CVD 1902 Oral Attenuated Vaccine to Prevent S Paratyphi A Infection
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase I Trial of a Live Oral Salmonella Enterica Serovar Paratyphi A Vaccine Harboring Mutations in guaBA and clpX
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The purpose of this study is to determine whether CVD 1902 a live attenuated oral vaccine is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection
Detailed Description:
Enteric fever is a life-threatening illness caused by several types of a bacterium known as Salmonella including Salmonella Paratyphi A In the United States about 400 cases occur each year and 75 of these are acquired while traveling internationally Typhoid fever is still common in the developing world where it affects about 215 million persons each yearBesides being a first step towards a possible oral paratyphoid A vaccine for the prevention of enteric fever this Phase 1 trial will shed light on the suitability of the guaBAclpX strategy for attenuating non-typhoidal Salmonella also an emerging pathogens of public health importance This randomized double-blinded Phase I study in healthy is designed to investigate the safety clinical tolerability and immunogenicity in a dose escalating fashion of a live oral attenuated S Paratyphi A at four dose levels 106 107 108 and 109 CFU We hypothesize that S Paratyphi A strains harboring mutations in guaBA and clpX will be well tolerated in the full dose range tested and that a single inoculation at the highest dose will elicit vigorous humoral and cell-mediated immune responses in humans
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Paratyphi CVD 1000 | OTHER | None | None |
| DMID 09-0020 | OTHER | None | None |
| U54AI057168 | NIH | DMID | httpsreporternihgovquickSearchU54AI057168 |