Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine - Full Text View

Purpose

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

Condition	Intervention	Phase
Smallpox	Drug: MVA Smallpox vaccine Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Enrollment:	590
Study Start Date:	July 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466245

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc

More Information

No publications provided

Responsible Party:	Clinical Operations Manager, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00466245 History of Changes
Obsolete Identifiers:	NCT00170651
Other Study ID Numbers:	H-249-002
Study First Received:	April 25, 2007
Last Updated:	January 14, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi:

MVA Vaccine

Additional relevant MeSH terms:

Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013