A Randomized, Double-Blind, Placebo-Controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00316524
First received: April 19, 2006
Last updated: December 21, 2007
Last verified: December 2007
  Purpose

The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.

In addition the study further investigates the safety profile of MVA-BN® in a healthy population compared to placebo.


Condition Intervention Phase
Smallpox
Biological: MVA-BN® (IMVAMUNE)
Biological: IMVAMUNE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Partially Randomized, Partially Double-Blind, Placebo-Controlled Phase II Non-Inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • MVA-specific seroconversion rate derived from the ELISA specific antibody titers 2 weeks after the last vaccination [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • To compare the four different vaccination groups with regard to ECG changes and cardiac symptoms [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Enrollment: 745
Study Start Date: May 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: 1 Biological: MVA-BN® (IMVAMUNE)
2 immunizations: 1 x 10E8_TCID
Experimental: 2 Biological: IMVAMUNE
1x 10E8_TCID50, 1x Placebo
Placebo Comparator: 3
2x Placebo
Biological: IMVAMUNE
2 x Placebo
Experimental: 4
1 immunization: 1x 10E8_TCID50
Biological: IMVAMUNE
1x 10E8_TCID50

Detailed Description:

The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects between 18 and 55 years of age.
  2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
  3. 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. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
  4. Lab values without clinically significant findings
  5. Electrocardiogram (ECG) without abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).

Exclusion Criteria:

  1. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
  2. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
  3. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  4. 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.
  5. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
  6. History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
  7. 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.
  8. History of anaphylaxis or severe allergic reaction.
  9. Immune modulatory therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316524

Locations
Germany
Harrison Clinical Research GmbH
Munich, Bavaria, Germany, 80636
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Frank von Sonnenburg, Prof Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich
  More Information

No publications provided

Responsible Party: Monika Fluer, Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316524     History of Changes
Other Study ID Numbers: POX-MVA-005, DMID 05-0128, EudraCT No. 2005-001781-14
Study First Received: April 19, 2006
Last Updated: December 21, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Bavarian Nordic:
Smallpox
Vaccination
Prevention

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014