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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
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring MVA Vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 25, 2007
    Last Updated
    January 17, 2014
    Sponsor
    Sanofi Pasteur, a Sanofi Company
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    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

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    Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine

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