Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053508
Status:
TERMINATED
Last Update Posted:
2014-01-22
First Post:
2003-01-30
Brief Title:
Dose Safety Tolerability and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
The Effect of Dose On Safety Tolerability and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2 Randomized Double-Blind Dose-Response Study
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CDCs decision to down-select vaccine development to single candidate ACAM2000
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 examine the safety and the effectiveness of a new vaccine for the prevention of the disease smallpox
Detailed Description:
In addition to assessment of safety parameters the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90 of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine Specifically the objectives of this study are to
1 Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax in healthy adults 18-29 years of age and naïve to smallpox vaccine Safety and tolerability will be determined by examination of the local cutaneous reaction adverse events physical examinations vital signs structured interviews and laboratory analysis
2 Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax in healthy adults 18-29 years of age by comparing athe proportion of subjects at each dose level who develop a major cutaneous reaction bthe proportion of subjects in each treatment group who develop neutralizing antibodies including the fold-increase in antibody titer between Baseline and Day 30 sera and the geometric mean vaccinia neutralizing antibody titer on Day 30
3 Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90 of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine
1 Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax in healthy adults 18-29 years of age and naïve to smallpox vaccine Safety and tolerability will be determined by examination of the local cutaneous reaction adverse events physical examinations vital signs structured interviews and laboratory analysis
2 Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax in healthy adults 18-29 years of age by comparing athe proportion of subjects at each dose level who develop a major cutaneous reaction bthe proportion of subjects in each treatment group who develop neutralizing antibodies including the fold-increase in antibody titer between Baseline and Day 30 sera and the geometric mean vaccinia neutralizing antibody titer on Day 30
3 Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90 of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine
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