NCT00316602

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

January 9, 2019

Completed
Last Updated

January 9, 2019

Status Verified

December 1, 2018

Enrollment Period

3.3 years

First QC Date

April 20, 2006

Results QC Date

November 27, 2018

Last Update Submit

December 19, 2018

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisSmallpoxVaccination

Outcome Measures

Primary Outcomes (1)

  • 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.

    week 6

Secondary Outcomes (11)

  • Percentage of Participants With Seroconversion by ELISA

    within 32 weeks

  • ELISA GMT

    within 32 weeks

  • Percentage of Participants With Seroconversion by PRNT

    within 32 weeks

  • PRNT GMT

    within 32 weeks

  • ELISPOT IFN-γ Values

    within 6 weeks

  • +6 more secondary outcomes

Study Arms (2)

Healthy Participants

EXPERIMENTAL

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

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)

Biological: IMVAMUNE

Interventions

IMVAMUNEBIOLOGICAL

Subjects receiving two subcutaneous vaccinations

Also known as: MVA-BN
Atopic Dermatitis ParticipantsHealthy Participants

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Alta Clinical Research LLC

Tucson, Arizona, 85745, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Rx Clinical Research, Inc.

Garden Grove, California, 92843, United States

Location

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Adult & Pediatric Dermatology PC

Overland Park, Kansas, 66211, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0093, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106-5239, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 75230, United States

Location

Dermatology Clinical Research

San Antonio, Texas, 78229, United States

Location

Hospital Juárez de México

Magdalena de las Salinas, CP, 07760, Mexico

Location

Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"

Guadalajara, Jalisco, Mexico

Location

Hospital General de México

Mexico City, 6760, Mexico

Location

CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)

Mexico City, Mexico

Location

Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico

Mexico City, Mexico

Location

Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"

Monterrey, 64460, Mexico

Location

Hospital Angel Leañol, Dermatology

Zapopan, Jalisco, 45200, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 26439129RESULT

MeSH Terms

Conditions

Dermatitis, AtopicSmallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPoxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title
Program Lead, Clinical Operations
Organization
Bavarian Nordic A/S
info@bavarian-nordic.com
+45 3326

Study Officials

  • Richard N Greenberg, M.D.

    University of Kentucky School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 21, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2009

Study Completion

April 1, 2010

Last Updated

January 9, 2019

Results First Posted

January 9, 2019

Record last verified: 2018-12

Locations

US(15)ME(7)