NCT00189943

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 19, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Smallpox

Interventions

MVA-BNBIOLOGICAL

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Prior vaccination against smallpox (study part I only)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PharmPlanNet Contract Research GmbH

Mönchengladbach, 41061, Germany

Location

MeSH Terms

Conditions

Smallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Karl M Eckl, MD

    PharmPlanNet Cantract Research GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 1, 2001

Study Completion

July 1, 2003

Last Updated

September 19, 2005

Record last verified: 2005-09

Locations

DE(1)