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

January 17, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

590

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Study Completion
Study Completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity
Time Frame: Study Completion
Study Completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-249-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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