Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects - Full Text View

Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

This study has been completed.

Sponsored by:	Bavarian Nordic
Information provided by:	Bavarian Nordic
ClinicalTrials.gov Identifier:	NCT00189943

Purpose

The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers

Condition	Intervention	Phase
Smallpox	Biological: MVA-BN	Phase I

MedlinePlus related topics:

Smallpox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety Study

Official Title:	Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects

Further study details as provided by Bavarian Nordic:

Estimated Enrollment:	90
Study Start Date:	April 2001
Estimated Study Completion Date:	July 2003

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male subjects, aged 20 - 55 years
Signed informed consent

Exclusion Criteria:

Prior vaccination against smallpox (study part I only)
Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
Any immune modifying therapy within 4 weeks prior to entry
Participation in any other investigating drug trial
Known allergy to a component which may be part of the vaccine
Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189943

Locations


Germany
	PharmPlanNet Contract Research GmbH
	Moenchengladbach, Germany, 41061

Sponsors and Collaborators

Bavarian Nordic

Investigators


Principal Investigator:	Karl M Eckl, MD	PharmPlanNet Cantract Research GmbH

More Information

Study ID Numbers:	MVA-POX-001, Bavarian Nordic
First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00189943
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Virus Diseases

Smallpox

Poxviridae Infections

DNA Virus Infections

Healthy

ClinicalTrials.gov processed this record on September 19, 2008