Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466245
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2007-04-25
Brief Title:
Phase 2 Study of Safety Tolerability and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Double-Blind Placebo-Controlled Dose-Finding Phase 2 Study Assessing Safety Tolerability Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara Smallpox Vaccine in Adults With and Without Previous Smallpox Vaccination
Status:
COMPLETED
Status Verified Date:
2014-01
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:
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels
Detailed Description:
This study will be a randomized double-blind placebo-controlled out-patient study conducted in multiple centers in the United States US Up to 700 healthy male and female adult subjects 18 to 55 years of age inclusive who have been previously vaccinated or subjects who are naïve to smallpox vaccine will be enrolled Subjects will be randomized to 1 of 8 treatment groups with 100 or 50 placebo subjects per group in which they will receive either ACAM3000 MVA Smallpox Vaccine 1 of 3 dose levels or placebo on Study Days 0 and 28 All personnel associated with the trial will be blinded as to treatment with the exception of the study pharmacist who prepares the treatment for administration to each subject There are 2 control groups in this study A comparison of adverse events and other safety assessments between placebo and ACAM3000 MVA Smallpox Vaccine will be performed In addition to serving as a control for safety the previously vaccinated subjects receiving placebo will serve as a control for antibody and T-cell responses in persons with preexisting immunity who receive ACAM3000 MVA Smallpox Vaccine Safety tolerability and immunogenicity data for 110 subjects undergoing primary immunization with graded doses of ACAM3000 MVA Smallpox Vaccine will be available following completion of Acambis protocol H-249-001 an ongoing phase I clinical trial The doses levels in this study may be changed following the availability of results from protocol H-249-001 Statistical analysis will focus on comparisons among the dose levels of ACAM3000 MVA Smallpox Vaccine and comparisons of ACAM3000 MVA Smallpox Vaccine to placebo as appropriate A separate analysis will be performed for previously vaccinated and naïve subjects Descriptive statistics will be used to compare demographic and baseline clinical data between stratum
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