SmallpoxPhase 1NCT00389103
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
A Phase 1 study testing MVA (smallpox vaccine) in people with Smallpox and Atopic Dermatitis, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox, Atopic Dermatitis
- What is being tested?
- MVA (smallpox vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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)
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.
- Conditions
- Smallpox, Atopic Dermatitis
- Being tested
- MVA (smallpox vaccine)
- Medical subject headings
- Smallpox, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA (smallpox vaccine)Biological
Also called placebo
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Biological: MVA (smallpox vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Study Completion
Secondary outcomes (1)
Immunogenicity
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: Senior management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389103
- Sponsor's protocol ID
- H-249-005
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2006
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00389103
- Acronym / sponsor ID
- H-249-005
- Conditions
- Smallpox, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Senior management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 18 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: MVA (smallpox vaccine) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA (smallpox vaccine)Also: placebo0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections | Biological | placebo |
Primary outcome
Safety
Time frame: Study Completion
1 secondary outcome
Immunogenicity
Time frame: Study Completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA (smallpox vaccine) in people with Smallpox and Atopic Dermatitis, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Study Completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.