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

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ClinicalTrials.gov Identifier: NCT00466245
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.

Condition or disease Intervention/treatment Phase
Smallpox Drug: MVA Smallpox vaccine Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Previously vaccinated for smallpox, 1x10-8 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: B
Smallpox vaccine naive, 1x10-8 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: C
Previous smallpox vaccination, 1x10-7 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: D
Smallpox vaccine naive, 1x10-7 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: E
Previous smallpox vaccination, 1x10-6 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: F
Smallpox vaccine naive, 1x10-6 dose
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: G
Previous smallpox vaccination, placebo dose
Drug: Placebo
Two 0.5mL subcutaneous injections, separated by 28 days
Experimental: H
Smallpox vaccine naive, placebo dose
Drug: Placebo
Two 0.5mL subcutaneous injections, separated by 28 days



Primary Outcome Measures :
  1. Safety [ Time Frame: Study Completion ]

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Study Completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466245


Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00466245     History of Changes
Obsolete Identifiers: NCT00170651
Other Study ID Numbers: H-249-002
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
MVA Vaccine

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs