Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038987
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2002-06-06
Brief Title:
Vaccinia Virus Vaccine APSV in Vaccinia- Naive Subjects PILOT
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety and Preliminary Efficacy of Various Concentrations of Aventis Pasteurs Smallpox Vaccine USP APSV in Vaccinia-naive Adults
Status:
COMPLETED
Status Verified Date:
2003-12
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:
To define the safety of vaccination with APSV as determined by the reactogenicity of the vaccine and the development of expected and un-expected adverse events associated with vaccination
To assess the proportion of individuals who respond to vaccination with a take those who form a visible lesion at the injection site 6 to 8 days after the vaccination
To assess the proportion of individuals who respond to vaccination with a take those who form a visible lesion at the injection site 6 to 8 days after the vaccination
Detailed Description:
The study will be a four-center randomized dose finding trial to evaluate safety preliminary efficacy and immunogenicity of Aventis Pasteur smallpox vaccine APSV in healthy vaccinia-naive adults Four concentrations of APSV derived from 2 lots of vaccine will be tested ranging from 10 exponent 6 pfu per ml to 10 exponent 75 pfu per ml Four concentrations of Dryvax ranging from 10 exp 6 per ml to 10 exp 8 per ml will be evaluated as a positive control This study is designed to assess the feasibility of the use of APSV and dilutions of APSV in an emergency vaccination scenario The study will be conducted in two phases The initial phase will consist of a single-center randomized open-label study in 45 subjects to evaluate the safety and approximate the take rate of undiluted APSV two lots APSV plus a Dryvax control arm n15 per arm A 14 day post vaccination safety follow-up will be completed for all subjects vaccinated in the initial phase prior to initiation of the second phase of the study with an additional 285 subjects All subjects will be followed for 56 days post vaccination with a clinic visit at day 180 for stage 1 subjects and a follow-up phone call at day 180 for stage 2 subjects The expansion phase of the study will be conducted at three additional sites
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