Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders

January 8, 2019 updated by: Bavarian Nordic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80802
        • Department of Infectious Diseases and Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GP 1: healthy, no AD
Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
Biological: IMVAMUNE (MVA-BN)
1x10E08 TCID50, subcutaneous vaccination
Experimental: GP2: prev. allerg. rhinitis
Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
Biological: IMVAMUNE (MVA-BN)
1x10E08 TCID50, subcutaneous vaccination
Experimental: GP3: history of AD
Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
Biological: IMVAMUNE (MVA-BN)
1x10E08 TCID50, subcutaneous vaccination
Experimental: GP4: active AD
Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
Biological: IMVAMUNE (MVA-BN)
1x10E08 TCID50, subcutaneous vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence, relationship and intensity of any serious adverse event at any time during the study.

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bavarian Nordic

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Frank von Sonnenburg, M.D., Department of Infectious Diseases and Tropical Medicine of the University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POX-MVA-007
  • N01-AI-30016 (Other Grant/Funding Number: NIAID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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