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To date, more than 2,200 subjects have been vaccinated with IMVAMUNE® in 11 completed and ongoing Phase I and Phase II clinical trials. A large proportion of these study subjects (more than 750) are immune-compromised, i.e. HIV infected or diagnosed with Atopic Dermatitis (AD).
Bavarian Nordic has completed a clinical safety report from a large Phase II study with IMVAMUNE® in HIV infected subjects that confirms the excellent safety profile of IMVAMUNE®. Within the next few days the safety report of this study will be submitted to the FDA and this will trigger a USD 25 million milestone payment under the RFP-3 contract. The clinical safety report constitutes a major part of the data package that will be used to potentially support the use of IMVAMUNE® in a declared emergency.
In support of using IMVAMUNE® as a smallpox vaccine in individuals otherwise contraindicated to receive conventional vaccinia vaccines, Bavarian Nordic has performed a large Phase II study in HIV infected subjects with CD4 counts between 200 and 750 cells/µl to compare the safety to healthy subjects.
The safety report from this study, which represents an essential part of the EUA data package, includes safety data from over 300 HIV infected and 86 healthy subjects, all of whom had no history of prior smallpox vaccination. The low number of adverse events confirmed the favourable safety profile of IMVAMUNE® in vaccinia-naïve HIV infected subjects with varying degrees of immune suppression. Indeed, there was no difference in adverse events between the healthy and HIV infected subjects, even in the most immune compromised patients (CD4 counts ≥ 200-350 cells/µl). IMVAMUNE® has now been tested in more than 2,200 people in 11 completed or on-going clinical studies, which includes a large proportion (more than 750) of immune-compromised people i.e. HIV infected or diagnosed with Atopic Dermatitis (AD) who are excluded from vaccination with traditional smallpox vaccines.
The complete data set from this trial is expected to be reported in the second half of 2009. The final report will include data on immunogenicity as well as long-term (6-month) safety information and will contain data from subjects enrolled in an additional study arm funded by the NIH under RFP-2 (HIV infected subjects with a history of previous exposure to a conventional smallpox vaccine).
An end of Phase II meeting has been requested with the FDA in order to discuss the Phase III study design and data requirements for a biologic licence application (BLA) with the FDA. The meeting is expected to take place early in 2009.
Recruitment of the Phase II study in patients diagnosed with AD funded under RFP-2 is continuing. Together with a previous Phase I study, the use of IMVAMUNE® in this population has so far been shown to be safe and well tolerated in more than 200 subjects diagnosed with AD; another population excluded from vaccination with traditional smallpox vaccines. The active study phase is planned to be completed in the first quarter of 2009, due to a slight delay in the recruiting of this difficult population, although this has no effect on the planned completion of the study, during the second half of 2009.
As planned, Bavarian Nordic has initiated a Phase II study to demonstrate the effect of IMVAMUNE® when administered as a booster dose (re-vaccination) two years after primary vaccination with IMVAMUNE®. Recruitment is currently ongoing and expected to be completed by the end of 2008.
The planned initiation of a study in subjects between 56 and 80 years of age to generate safety and immunogenicity data in an elderly population has been postponed until the first half of 2009.
Scientific Articles on this topic:
Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine
Modified vaccinia virus Ankara protects macaques against respiratory challenge with monkeypox virus
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