Currently, we are working closely together with Intravacc, the Institute for Translational Vaccinology, and Leiden University. Together, three study designs are planned, as follows:

1.       Human skin study. In this trial, the DermalDose system will be tested on ex-vivo human skin to confirm the reliability of the injections. During the trial four components will be studied: Efficiency, leakage, penetration depth and injected volume post injection.

2.       Animal study. This study is meant to evaluate the efficacy of intradermal injection with the DermalDose system in vivo. During this study, small animals will be injected with a reference vaccine. Half of the animals will receive an intramuscular immunization, the other half will receive an intradermal immunization via the DermalDose system. The potency of each route of administration will be evaluated with thorough immunological techniques. 

3.  Clinical trial. In this trial, the DermalDose system will be tested on tolerability in humans. The system will be compared with conventional needle and syringe intradermal injection (mantoux) and intramuscular injection. Various factors, including pain experience, ease of use, local (skin) reaction to the inoculum etc will be evaluated.

These studies will provide new insight and guide the further development of the DermalDose system. Currently, the system is registered with CE-mark class 1. If the tests are successful, the results of the clinical trial will be used to upgrade the system to CE-mark class 2.

Next to this, a few changes in the handheld have been implemented. The first one is a safety catch. This ensures that the injection can only take place by a minimal pressure of the handheld on the skin and prevents incomplete injection. The second change that has been made is adjusting the injectionpressure. The pressure, which is used to inject the fluid into the skin, is now equal to the pressure used by a conventional needle and syringe. This ensures minimal mechanical damage on the skin.

Hopefully, this update provides some insight in the development of the DermalDose system.

Please feel free to Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken. with any questions you might have.