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Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

Primary Purpose

Smallpox, Atopic Dermatitis

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MVA (smallpox vaccine)

About this trial

This is an interventional prevention trial for Smallpox

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination
Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study
Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria
At the time of screening, the subject must have "mild to moderate" AD.

Exclusion Criteria:

History or evidence of prior exposure to a vaccinia or MVA- containing product
known or suspected history of immunodeficiency other than AD
Known or suspected impairment of major organ function
Known history or diagnosis of cardiac disease or cerebrovascular disease
presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns.
Dementia or history of seizures
Known allergies to MVA or any known components of the vaccine
transfusion of blood, organ transplantation, or treatment with any blood product
morbid obesity, or a BMI less than or equal to 18.5
history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use
history of major psychiatric illness except major depression not requiring medical therapy.
subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0

Sites / Locations

Academic Dermatology Associates
Oregon Health & Science University
DermResearch, Inc.

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Immunogenicity

Full Information

NCT ID

NCT00389103

First Posted

October 16, 2006

Last Updated

January 17, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00389103

Brief Title

Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

Official Title

A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Senior management decision

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (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

purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.

Detailed Description

This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smallpox, Atopic Dermatitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

MVA (smallpox vaccine)

Other Intervention Name(s)

placebo

Intervention Description

0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections

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

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria At the time of screening, the subject must have "mild to moderate" AD. Exclusion Criteria: History or evidence of prior exposure to a vaccinia or MVA- containing product known or suspected history of immunodeficiency other than AD Known or suspected impairment of major organ function Known history or diagnosis of cardiac disease or cerebrovascular disease presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns. Dementia or history of seizures Known allergies to MVA or any known components of the vaccine transfusion of blood, organ transplantation, or treatment with any blood product morbid obesity, or a BMI less than or equal to 18.5 history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use history of major psychiatric illness except major depression not requiring medical therapy. subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc

Official's Role

Study Director

Facility Information:

Facility Name

Academic Dermatology Associates

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

DermResearch, Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

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