Non-replicating smallpox vaccine candidate.
IMVAMUNE® is in Phase 3 clinical development.
The vaccine is sold to governments as a vaccine under
IMVAMUNE® has been shown in clinical trials to be a well
tolerated smallpox vaccine in healthy subjects and persons with
contraindications to traditional smallpox vaccines. To date, more
than 3,600 individuals, including HIV and atopic dermatitis
patients, have been vaccinated and none of the serious adverse
events normally associated with the traditional smallpox vaccines
have been seen, including no cases of myo-/pericarditis.
IMVAMUNE® is based on a live non-replicating MVA-BN® (a
strain of the Modified Vaccinia Ankara) virus. Although the
MVA-BN® virus is highly attenuated it is still capable of
eliciting a potent immune response.
IMVAMUNE® - a unique profile
A number of differences exist between IMVAMUNE® and
traditional smallpox vaccines. The vaccine virus contained in
IMVAMUNE® does not proliferate in the body and therefore does
not generate the post-vaccination complications associated with
traditional smallpox vaccines. In addition, in recent pre-clinical
trials, IMVAMUNE® has been shown to generate an immune response
faster than traditional replicating vaccines (3-4 days vs. 10-14
days). Furthermore, IMVAMUNE® is injected - much like other
modern vaccines today - rather than pricked into the skin, e.g.
with a bifurcated needle as is the case with traditional
Best characterised MVA smallpox vaccine candidate
Bavarian Nordic's programme to develop a safe smallpox vaccine
began in 1999 with the goal of being the first safe smallpox
vaccine approved for use by the general population, including the
immune compromised. To achieve that objective, the company's
clinical development focus has been to test the safety of
IMVAMUNE® in immune-compromised populations and determine
IMVAMUNE®'s efficacy in approved animal models.
To-date, the company has shown IMVAMUNE® to be the best
characterised MVA based on:
- Comprehensive preclinical animal data (in 2 mice models and a
non-human primate model)
- Completed phase I and II studies in healthy subjects, subjects
with atopic dermatitis and HIV infected subjects
- Additional Phase II studies started in at-risk populations
(HIV, atopic dermatitis, elderly)