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WithdrawnNCT00389103Updated Jan 22, 2014

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

A Phase 1 interventional study of MVA (smallpox vaccine) in Smallpox and Atopic Dermatitis, sponsored by Sanofi Pasteur, a Sanofi Company. Withdrawn at 3 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 1, Interventional, and Prevention

Why this study was withdrawn
Senior management decision
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Smallpox
  • Atopic Dermatitis
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In context

Smallpox

73 studies on the registry are indexed under Smallpox; 5 are open to participants now.

Browse Smallpox studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    placebo

    Biological: MVA (smallpox vaccine)

Interventions

  • BiologicalMVA (smallpox vaccine)

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

    Also known as: placebo

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What researchers measure

Primary outcomes

  1. Safety

    Time frame: Study Completion

Secondary outcomes

  1. Immunogenicity

    Time frame: Study Completion

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Study locations

3 sites
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • DermResearch, Inc.
    Austin, Texas 78759, United States
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00389103
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Oct 18, 2006
Start date
Oct 2006
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Jan 22, 2014

Study contacts

Medical Director
study director · Sanofi Pasteur Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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