Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
Primary Purpose
Smallpox
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MVA Smallpox vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Smallpox focused on measuring MVA Vaccine
Eligibility Criteria
Inclusion Criteria:
- subjects must be in good general health, checked on toxicity grading table.
- for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
- for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
- Female subjects must not be pregnant or lactating.
Exclusion Criteria:
- Subjects who participated in a "first responder" program.
- any history of immunodeficiency.
- any autoimmune disease
- any history of cardiac disease
- any diagnosed risk factors for ischemic coronary disease
- any history of heart palpitations or abnormalities in cardiac rhythm.
- any current or history of eczema of any description.
- Known allergy to MVA or any of its components, including eggs or egg products.
- morbid obesity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
E
F
G
H
Arm Description
Previously vaccinated for smallpox, 1x10-8 dose
Smallpox vaccine naive, 1x10-8 dose
Previous smallpox vaccination, 1x10-7 dose
Smallpox vaccine naive, 1x10-7 dose
Previous smallpox vaccination, 1x10-6 dose
Smallpox vaccine naive, 1x10-6 dose
Previous smallpox vaccination, placebo dose
Smallpox vaccine naive, placebo dose
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Immunogenicity
Full Information
NCT ID
NCT00466245
First Posted
April 25, 2007
Last Updated
January 17, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00466245
Brief Title
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
MVA Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
590 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Previously vaccinated for smallpox, 1x10-8 dose
Arm Title
B
Arm Type
Experimental
Arm Description
Smallpox vaccine naive, 1x10-8 dose
Arm Title
C
Arm Type
Experimental
Arm Description
Previous smallpox vaccination, 1x10-7 dose
Arm Title
D
Arm Type
Experimental
Arm Description
Smallpox vaccine naive, 1x10-7 dose
Arm Title
E
Arm Type
Experimental
Arm Description
Previous smallpox vaccination, 1x10-6 dose
Arm Title
F
Arm Type
Experimental
Arm Description
Smallpox vaccine naive, 1x10-6 dose
Arm Title
G
Arm Type
Experimental
Arm Description
Previous smallpox vaccination, placebo dose
Arm Title
H
Arm Type
Experimental
Arm Description
Smallpox vaccine naive, placebo dose
Intervention Type
Drug
Intervention Name(s)
MVA Smallpox vaccine
Intervention Description
Two 0.5mL subcutaneous injections, separated by 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two 0.5mL subcutaneous injections, separated by 28 days
Primary Outcome Measure Information:
Title
Safety
Time Frame
Study Completion
Secondary Outcome Measure Information:
Title
Immunogenicity
Time Frame
Study Completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects must be in good general health, checked on toxicity grading table.
for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
Female subjects must not be pregnant or lactating.
Exclusion Criteria:
Subjects who participated in a "first responder" program.
any history of immunodeficiency.
any autoimmune disease
any history of cardiac disease
any diagnosed risk factors for ischemic coronary disease
any history of heart palpitations or abnormalities in cardiac rhythm.
any current or history of eczema of any description.
Known allergy to MVA or any of its components, including eggs or egg products.
morbid obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
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