Novosanis has developed an intradermal injection device designed to improve accuracy and standardisation.
Novosanis is an innovative developer and producer of medical devices with ISO-13485 certification. A privately held Belgian company, it has been endorsed nationally and internationally for its healthcare solutions. The company has two dedicated business units for sampling and delivery solutions. Novosanis specialises in user-friendly and game-changing medical devices that meet all regulatory and quality requirements, and improve accuracy and standardisation, while making handling easier, more consistent and more comfortable for the user.
Most vaccines are currently administered intramuscularly (IM). Intradermal (ID) administration has several advantages over IM administration, including an improved immune response, but its use is limited due to the difficulty in standardising injections with the Mantoux technique. Novosanis has a solution to improve accuracy and standardisation of ID injection and drug delivery: VAX-ID.
The VAX-ID device platform is a patented, award-winning and proven platform of injection devices suited for accurate drug delivery - of therapeutic, prophylactic and allergy vaccines, for example - in the dermal layer of the skin. VAX-ID is a newly developed ID injection device, allowing accurate and standardised injection in the dermis with high ease of use. To evaluate the device's effectiveness, a Phase 1 trial was performed by Van Mulder et al to assess for immunogenicity of a hepatitis B vaccine (HBVAXPRO, Sanofi Pasteur MSD) administered via IM and different ID routes in healthy pre-immunised subjects.
The study saw 48 healthy subjects aged 18-35 years old subdivided into four groups, each receiving different doses and dose frequencies of the vaccine with VAX-ID. Hepatitis B surface antibodies (Anti-HBs) were then measured.
Van Mulder et al concluded that ID administration of the hepatitis B vaccine resulted in higher immune responses compared with IM administration. Immune responses of subjects treated with VAX-ID were superior to those of subjects treated using IM and ID Mantoux methods. Mild solicited local reactions after ID injections were most likely caused by the aluminium adjuvants. VAX-ID was thus shown to be effective for ID injections, and even superior to IM and ID using the Mantoux technique.
VAX-ID offers benefits not only in patient care, with painless injections and more efficient healthcare practices, but also for the entire healthcare industry. In pharma and biotech, it offers the benefits of accurate dose delivery and injection depth, its dose-sparing potential, the reduction in risk for clinical trials and a lower skill threshold for users. For healthcare workers, VAX-ID is easy to use, prevents needle-stick injuries and offers safety locking.
"Following the successful Phase 1 study using the hepatitis B vaccine, the device will now be evaluated for its use in rabies vaccinations," says Vanessa Vankerckhoven, CEO of Novosanis. "The trial will kick off mid-2017. In addition to humoral antibody response, cellular response will also be measured in the participants.
"Novosanis is also developing a new two-chamber variant suited for small volumes of lyophilised vaccines (0.05-0.20cc). One chamber contains the powder while the other contains the diluent. The two chambers can be interconnected, after which reconstitution and ID injection of the liquid can be performed.
"Novosanis is actively scouting for opportunities for collaboration with biotech and pharma companies in need of accurate and standardised drug delivery," Vankerckhoven concludes. Novosanis will be at booth 161 at ECCMID 2017.