Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109304
Status:
WITHDRAWN
Last Update Posted:
2015-09-18
First Post:
2005-04-27
Brief Title:
Safety Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis VEE Attenuated Live-Virus Vaccine
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
Study Overview
Official Title:
Safety Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis VEE Attenuated Live-Virus Vaccine VEE IAB V3526 in VEE-Naive Healthy Volunteers After Single Dose Subcutaneous Administration
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to determine the safety and tolerability of a new investigational vaccine referred to as VEE IAB V3526 which may induce production of specific antibodies in vaccinated humans and may protect them against infection with the Venezuelan Equine Encephalitis VEE Virus
Detailed Description:
Safety Objectives 1 To determine preliminary safety reactogenicity and tolerability of VEE IAB V3526 in VEE-naïve healthy volunteers after single dose subcutaneous SC administration 2 To evaluate virological safety by assessing serum viremia and viral shedding in nose and throat
Immunogenicity Objectives 1 To assess the humoral immune response plaque reduction neutralizing antibody titer PRNT against VEE subtype IAB after SC administration of different dose-levels of the VEE IAB V3526 vaccine candidate 2 To assess duration of immune response over six months after the VEE IAB V3526 vaccination based on PRNT and 3 To identify two suitable VEE IAB V3526 vaccine dose-levels for future administration in dose optimization and expanded safety studies
Exploratory Objectives 1 To collect and store serum for future development of immunogenicity assays eg ELISA against multiple VEE subtypes IAB IE IIIA and other possible subtypes 2 To collect and store serum for future use in the development of a passive transfer challenge model 3 Collect VEE IAB V3526 positive serum Positive Control Serum at the Day 21 visit
Immunogenicity Objectives 1 To assess the humoral immune response plaque reduction neutralizing antibody titer PRNT against VEE subtype IAB after SC administration of different dose-levels of the VEE IAB V3526 vaccine candidate 2 To assess duration of immune response over six months after the VEE IAB V3526 vaccination based on PRNT and 3 To identify two suitable VEE IAB V3526 vaccine dose-levels for future administration in dose optimization and expanded safety studies
Exploratory Objectives 1 To collect and store serum for future development of immunogenicity assays eg ELISA against multiple VEE subtypes IAB IE IIIA and other possible subtypes 2 To collect and store serum for future use in the development of a passive transfer challenge model 3 Collect VEE IAB V3526 positive serum Positive Control Serum at the Day 21 visit
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