Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050518
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2002-12-11
Brief Title:
APSV in Vaccinia Naive Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Study of the Safety and Efficacy of Aventis Pasteurs Smallpox Vaccine USP APSV in Vaccinia-Naive Adults
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study seeks to define with precision the safety and efficacy of APSV two dose potencies of one lot in vaccinia-naive adults The ability of this vaccine to induce a classic take as defined by formation of a lesion at the injection site consistent with the Jennerian process see Appendix A and vaccine specific immune responses will be assessed The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live replicating smallpox vaccines Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses including variola The study also seeks to characterize preliminarily the cell mediated immune CMI response to APSV as compared to Dryvax
Detailed Description:
A Multicenter double blind randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination undiluted 15 dilution Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study
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