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Clinical Trials

Date: 2011-02-01

Type of information: Initiation of preclinical development

phase: 2

Announcement: completion of the study

Company: Bavarian Nordic (Denmark)

Product: Imvamune®

Action mechanism:

Disease:

smallpox in individuals suffering from atopic dermatitis

Therapeutic area: Infectious diseases

Country:

Trial details:

In the Phase 2 trial, 350 individuals with mild to moderate atopic dermatitis were vaccinated with IMVAMUNE®, a non-replicating smallpox vaccine. Adverse reactions and immune responses were compared to 282 healthy subjects. Vaccination with IMVAMUNE® was well tolerated in both study populations, and subjects with atopic dermatitis generated strong vaccinia specific immune responses similar to healthy subjects.

Latest news:

Bavarian Nordic has completed a clinical Phase 2 trial of its smallpox vaccine, Imvamune®, in individuals suffering from atopic dermatitis.  These individuals are at increased risk of severe side effects from conventional replicating smallpox vaccines.  Safety and immunogenicity data from the trial will be presented on February 5th at the Late Breaking Research Symposium at the annual meeting of the American Academy of Dermatology.

Despite its eradication, bioterrorism experts are concerned about the possibility of an attack on the U.S. that exposes the population to the smallpox virus.  The government currently stockpiles enough conventional smallpox vaccine to protect the entire American public in the event of a smallpox bioterrorism attack.  However, these replicating smallpox vaccines are not recommended and can cause severe complications for people with compromised immune systems or atopic dermatitis.  These rare but potentially life threatening complications include progressive vaccinia, generalized vaccinia, myo-/pericarditis and eczema vaccinatum.

Is general: Yes