Dermatitis, AtopicPhase 1NCT00189917
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
A Phase 1 study testing IMVAMUNE (MVA-BN) in people with Dermatitis, Atopic and Hay Fever, run by Bavarian Nordic at 1 site in Germany.
Trial summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Hay Fever
- What is being tested?
- IMVAMUNE (MVA-BN)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Dec 2005
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects
- Age 18-40.
- Read, signed and dated informed consent.
- Women of childbearing potential must use an acceptable method of contraception
- Group 1: Healthy subjects
- No history of atopic dermatitis as documented in the patient file
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- No active atopic dermatitis
- No other atopic disorders such as asthma or allergic rhinitis.
- Prick test without clinical significance
- IgE within normal range
- Group 2: Subjects with history of atopic dermatitis
- Group 3: Subjects with mild active atopic dermatitis
- SCORAD 1 - 15.
- Group 4: Subjects with mild allergic rhinitis
- At least one active allergic rhinitis phase during last year.
Who cannot join
- Known or suspected history of smallpox vaccination or typical vaccinia scar.
- Positive test result in MVA specific ELISA at screening.
- Positive result in HIV or HCV antibody test at screening.
- Surface antigen of Hepatitis B Virus (HBsAg) positive at screening.
- Pregnant or breast-feeding women.
- Positive pregnancy test at screening and/or within 24 hours prior to vaccination.
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- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the institutional upper limit of normal.
- Positive urine glucose by dipstick or urine analysis.
- Inadequate renal function defined as a serum creatinine above the institutional upper limit of normal; urine protein >30 mg/dl or trace proteinuria (by urine analysis or dipstick); and a calculated creatinine clearance <80 ml/min.
- Electrocardiogram (ECG) with clinical significance.
- Hemoglobin <11 g/dl; White blood cells less than 2,500 and more than 11,000/mm3; Platelets less than 140,000/mm3.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
- History of or active autoimmune disease.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- History of malignancy.
- History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- Any condition which might interfere with study objectives.
- History of immunodeficiency.
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
- Three or more of the following risk factors: High blood pressure, high blood cholesterol, diabetes mellitus or high blood sugar, a first degree relative who had a heart condition before the age of 50, smoking cigarettes.
- History of chronic alcohol abuse and/or intravenous drug abuse.
- History of allergic reactions likely to be exacerbated by any component of the vaccine.
- History of anaphylaxis or severe allergic reaction.
- Acute disease (illness with or without a fever) at the time of enrollment.
- Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
- Chronic administration of immuno-suppressant or immune-modifying drugs.
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- Administration or planned administration of immunoglobulins and/or any blood -- Use of any investigational or non-registered drug.
- Blood donation 8 weeks in advance or during study participation.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Infectious Diseases and Tropical Medicine
Munich, Bavaria, 80802
About this study
Official title: An Open-label, Controlled Phase I Pilot Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in 18-40 Year Old Vaccinia-naïve Subjects With Atopic Disorders
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
- Conditions
- Dermatitis, Atopic, Hay Fever
- Being tested
- IMVAMUNE (MVA-BN)
- Medical subject headings
- Dermatitis, Atopic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVAMUNE (MVA-BN)Biological
1x10E08 TCID50, subcutaneous vaccination
| Study group | Role | What they receive |
|---|---|---|
| GP 1: healthy, no AD | Experimental | Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. Receives: Biological: IMVAMUNE (MVA-BN) |
| GP2: prev. allerg. rhinitis | Experimental | Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. Receives: Biological: IMVAMUNE (MVA-BN) |
| GP3: history of AD | Experimental | Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. Receives: Biological: IMVAMUNE (MVA-BN) |
| GP4: active AD | Experimental | Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. Receives: Biological: IMVAMUNE (MVA-BN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Secondary outcomes (2)
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank von Sonnenburg, M.D., Principal investigator, Department of Infectious Diseases and Tropical Medicine of the University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189917
- Sponsor's protocol ID
- POX-MVA-007
- Other IDs
- N01-AI-30016
- Status last verified
- Jan 2019
- First submitted
- 11 Sep 2005
- Last updated
- 10 Jan 2019
- Results posted
- No
Publications
von Sonnenburg F, Perona P, Darsow U, Ring J, von Krempelhuber A, Vollmar J, Roesch S, Baedeker N, Kollaritsch H, Chaplin P. Safety and immunogenicity of modified vaccinia Ankara as a smallpox vaccine in people with atopic dermatitis. Vaccine. 2014 Sep 29;32(43):5696-702. doi: 10.1016/j.vaccine.2014.08.022. Epub 2014 Aug 20.
PubMed 25149431Darsow U, Sbornik M, Rombold S, Katzer K, von Sonnenburg F, Behrendt H, Ring J. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1971-1977. doi: 10.1111/jdv.13797. Epub 2016 Jun 29.
PubMed 27357167
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Controlled Phase I Pilot Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in 18-40 Year Old Vaccinia-naïve Subjects With Atopic Disorders
- ClinicalTrials.gov ID
- NCT00189917
- Acronym / sponsor ID
- POX-MVA-007
- Conditions
- Dermatitis, Atopic, Hay Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2004 (actual)
- Primary completion
- Dec 2005 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GP 1: healthy, no AD | Experimental | Biological: IMVAMUNE (MVA-BN)Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. |
| GP2: prev. allerg. rhinitis | Experimental | Biological: IMVAMUNE (MVA-BN)Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. |
| GP3: history of AD | Experimental | Biological: IMVAMUNE (MVA-BN)Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. |
| GP4: active AD | Experimental | Biological: IMVAMUNE (MVA-BN)Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- All subjects
- Age 18-40.
- Read, signed and dated informed consent.
- Women of childbearing potential must use an acceptable method of contraception
- Group 1: Healthy subjects
Key exclusion criteria (30 listed)
- Known or suspected history of smallpox vaccination or typical vaccinia scar.
- Positive test result in MVA specific ELISA at screening.
- Positive result in HIV or HCV antibody test at screening.
- Surface antigen of Hepatitis B Virus (HBsAg) positive at screening.
- Pregnant or breast-feeding women.
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 |
|---|---|---|
| IMVAMUNE (MVA-BN)1x10E08 TCID50, subcutaneous vaccination | Biological | GP 1: healthy, no AD, GP2: prev. allerg. rhinitis, GP3: history of AD, GP4: active AD |
Primary outcome
Occurrence, relationship and intensity of any serious adverse event at any time during the study.
2 secondary outcomes
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Results publication: PubMed 25149431von Sonnenburg F, Perona P, Darsow U, Ring J, von Krempelhuber A, Vollmar J, Roesch S, Baedeker N, Kollaritsch H, Chaplin P. Safety and immunogenicity of modified vaccinia Ankara as a smallpox vaccine in people with atopic dermatitis. Vaccine. 2014 Sep 29;32(43):5696-702. doi: 10.1016/j.vaccine.2014.08.022. Epub 2014 Aug 20.
- Results publication: PubMed 27357167Darsow U, Sbornik M, Rombold S, Katzer K, von Sonnenburg F, Behrendt H, Ring J. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1971-1977. doi: 10.1111/jdv.13797. Epub 2016 Jun 29.
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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.
Frank von Sonnenburg, M.D. principal investigator
Department of Infectious Diseases and Tropical Medicine of the University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMVAMUNE (MVA-BN) in people with Dermatitis, Atopic and Hay Fever, run by Bavarian Nordic at 1 site in Germany.
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 15 inclusion and 30 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: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence, relationship and intensity of any serious adverse event at any time during the study.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189917, which also lists 2 linked publications.
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 10 Jan 2019.