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A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMVAMUNE
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Smallpox, Vaccination

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Alta Clinical Research LLC
  • Burke Pharmaceutical Research
  • Rx Clinical Research, Inc.
  • Solano Clinical Research
  • Northwestern University
  • Adult & Pediatric Dermatology PC
  • University of Kentucky Medical Center
  • Saint Louis University
  • Sundance Clinical Research
  • Meridian Clinical Research
  • Academic Dermatology Associates
  • Dermatology Associates of Rochester
  • Oregon Dermatology & Research Center
  • Dermatology Treatment & Research Center
  • Dermatology Clinical Research
  • Hospital Juárez de México
  • Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
  • Hospital General de México
  • CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
  • Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
  • Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
  • Hospital Angel Leañol, Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Participants

Atopic Dermatitis Participants

Arm Description

Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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'.
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.
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'.
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
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
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.
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.
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.
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine

Full Information

First Posted
April 20, 2006
Last Updated
December 19, 2018
Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00316602
Brief Title
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Smallpox, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Participants
Arm Type
Experimental
Arm Description
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
Arm Title
Atopic Dermatitis Participants
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
IMVAMUNE
Other Intervention Name(s)
MVA-BN
Intervention Description
Subjects receiving two subcutaneous vaccinations
Primary Outcome Measure Information:
Title
Percentage of Participants With Seroconversion by ELISA
Description
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.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With Seroconversion by ELISA
Description
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.
Time Frame
within 32 weeks
Title
ELISA GMT
Description
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'.
Time Frame
within 32 weeks
Title
Percentage of Participants With Seroconversion by PRNT
Description
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.
Time Frame
within 32 weeks
Title
PRNT GMT
Description
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'.
Time Frame
within 32 weeks
Title
ELISPOT IFN-γ Values
Description
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
Time Frame
within 6 weeks
Title
Number of Participants With SAEs
Description
Occurrence, relationship and intensity of any serious AE (SAE)
Time Frame
within 32 weeks
Title
Number of Participants With Related Grade >=3 Adverse Events
Description
Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Time Frame
within 29 days after vaccination
Title
Number of Participants With Solicited Local Adverse Events
Description
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.
Time Frame
within 8 days after any vaccination
Title
Number of Participants With Solicited General AEs
Description
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.
Time Frame
within 8 days after any vaccination
Title
Number of Unsolicited Non-serious Adverse Events: Intensity
Description
Occurrence of unsolicited non-serious AEs by Intensity
Time Frame
within 29 days after any vaccination
Title
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Description
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time Frame
within 29 days after any vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard N Greenberg, M.D.
Organizational Affiliation
University of Kentucky School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alta Clinical Research LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Rx Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Adult & Pediatric Dermatology PC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-5239
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dermatology Treatment & Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Dermatology Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hospital Juárez de México
City
Magdalena De Las Salinas
State/Province
CP
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Hospital General de México
City
Mexico City
ZIP/Postal Code
6760
Country
Mexico
Facility Name
CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
City
Mexico City
Country
Mexico
Facility Name
Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
City
Mexico City
Country
Mexico
Facility Name
Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Angel Leañol, Dermatology
City
Zapopan, Jalisco
ZIP/Postal Code
45200
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
26439129
Citation
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. Erratum In: PLoS One. 2015;10(11):e0142802. Hurley, Yadira [corrected to Hurley, Maria Yadira].
Results Reference
result

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A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

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