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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189943

Enrollment

Registered

2005-09-19

Start date

2001-04-30

Completion date

2003-07-31

Last updated

2005-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smallpox

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

Interventions

BIOLOGICALMVA-BN

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026