Atopic DermatitisPhase 2NCT00316602
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
A Phase 2 study testing IMVAMUNE in people with Atopic Dermatitis, run by Bavarian Nordic at 22 sites in 2 countries.
Trial summary
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- IMVAMUNE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jul 2006to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Group 1 (Healthy Participants):
- Subjects without present or history of any kind of atopy.
- Group 2 (Atopic Dermatitis Participants):
- Subjects with diagnosed atopic dermatitis.
- All study subjects:
- Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
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- Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.
- Lab values without clinically significant findings.
- Electrocardiogram (ECG) without clinically significant findings.
Who cannot join
- Pregnant or breast-feeding women.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- 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, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
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- History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
- History of anaphylaxis or severe allergic reaction.
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- Administration of immunomodulatory substances.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States15 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239
Northwestern University
Chicago, Illinois, 60611
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Rx Clinical Research, Inc.
Garden Grove, California, 92843
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0093
Meridian Clinical Research
Omaha, Nebraska, 68134
Adult & Pediatric Dermatology PC
Overland Park, Kansas, 66211
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Dermatology Associates of Rochester
Rochester, New York, 14623
Dermatology Clinical Research
San Antonio, Texas, 78229
Saint Louis University
St Louis, Missouri, 63104
Sundance Clinical Research
St Louis, Missouri, 63141
Alta Clinical Research LLC
Tucson, Arizona, 85745
Solano Clinical Research
Vallejo, California, 94589
Mexico7 sites
Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco
Hospital Juárez de México
Magdalena de las Salinas, CP, 07760
Hospital General de México
Mexico City, 6760
CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
Mexico City
Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
Mexico City
Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
Monterrey, 64460
Hospital Angel Leañol, Dermatology
Zapopan, Jalisco, 45200
About this study
Official title: A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
- Conditions
- Atopic Dermatitis
- Being tested
- IMVAMUNE
- Keywords
- Atopic dermatitis, Smallpox, Vaccination
- Medical subject headings
- Dermatitis, Atopic, Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVAMUNEBiological
Also called MVA-BN
Subjects receiving two subcutaneous vaccinations
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE) Receives: Biological: IMVAMUNE |
| Atopic Dermatitis Participants | Experimental | Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] <= 30), receiving two doses of MVA-BN (IMVAMUNE) Receives: Biological: IMVAMUNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: week 6
Secondary outcomes (11)
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: within 32 weeks
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Measured: within 32 weeks
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: within 32 weeks
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Measured: within 32 weeks
ELISPOT IFN-γ Values
Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay
Measured: within 6 weeks
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Measured: within 32 weeks
Number of Participants With Related Grade >=3 Adverse Events
Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Measured: within 29 days after vaccination
Number of Participants With Solicited Local Adverse Events
Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Measured: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Measured: within 29 days after any vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard N Greenberg, M.D., Principal investigator, University of Kentucky School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316602
- Sponsor's protocol ID
- POX-MVA-008
- Other IDs
- HHSN266200400072C
- Status last verified
- Dec 2018
- First submitted
- 20 Apr 2006
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis. PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.
PubMed 26439129
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00316602
- Acronym / sponsor ID
- POX-MVA-008
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Smallpox, Vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Posted 9 Jan 2019
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 compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Biological: IMVAMUNEHealthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE) |
| Atopic Dermatitis Participants | Experimental | Biological: IMVAMUNEVaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] <= 30), receiving two doses of MVA-BN (IMVAMUNE) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects without present or history of any kind of atopy.
- Subjects with diagnosed atopic dermatitis.
- Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
- Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.
Key exclusion criteria (11 listed)
- Pregnant or breast-feeding women.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- 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, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
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 |
|---|---|---|
| IMVAMUNEAlso: MVA-BNSubjects receiving two subcutaneous vaccinations | Biological | Atopic Dermatitis Participants, Healthy Participants |
Primary outcome
Percentage of Participants With Seroconversion by ELISA
Time frame: week 6
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
11 secondary outcomes
Percentage of Participants With Seroconversion by ELISA
Time frame: within 32 weeks
ELISA GMT
Time frame: within 32 weeks
Percentage of Participants With Seroconversion by PRNT
Time frame: within 32 weeks
PRNT GMT
Time frame: within 32 weeks
ELISPOT IFN-γ Values
Time frame: within 6 weeks
Number of Participants With SAEs
Time frame: within 32 weeks
Number of Participants With Related Grade >=3 Adverse Events
Time frame: within 29 days after vaccination
Number of Participants With Solicited Local Adverse Events
Time frame: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Time frame: within 8 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Time frame: within 29 days after any vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26439129Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis. PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.
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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.
Richard N Greenberg, M.D. principal investigator
University of Kentucky School of Medicine
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVAMUNE in people with Atopic Dermatitis, run by Bavarian Nordic at 22 sites in 2 countries.
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 10 inclusion and 11 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 9 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 22 sites in United States, Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Seroconversion by ELISA (time frame: week 6). 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 NCT00316602, which also lists 1 linked publication.
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 9 Jan 2019.