MedDataX Logo

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

NCT ID: NCT00189943

Last Updated: 2005-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smallpox

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MVA-BN

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bavarian Nordic

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karl M Eckl, MD

Role: PRINCIPAL_INVESTIGATOR

PharmPlanNet Cantract Research GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PharmPlanNet Contract Research GmbH

Mönchengladbach, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bavarian Nordic

Identifier Type: -

Identifier Source: secondary_id

MVA-POX-001

Identifier Type: -

Identifier Source: org_study_id