Case Study: Addressing Cartridge Failure on DNA Vaccine Delivery Device

SGS addresses cartridge failures during the clinical trial for a DNA vaccine to ensure that the Phase 1 study could progress successfully.

A first-in-human, double-blind, randomized, placebo-controlled, Phase 1 study was undertaken to evaluate the safety, tolerability, reactogenicity, and immunogenicity of a DNA vaccine. The DNA vaccine was administered to participants with chronic hepatitis B by electroporation-mediated intramuscular injection, using an investigational delivery device. The device used single-use cartridges, in which the syringe with DNA vaccine is inserted.

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Key Challenge: DNA Vaccine Cartridge Failures

Cartridge failures were experienced during the Phase 1 study for the DNA vaccine, with some devices showing an error message and not injecting the vaccine.

Solutions and Outcome: A Comprehensive Plan to Deal With Cartridge Failures

SGS created a solution to ensure that patients would not need to wait for the next dose to be prepared by the pharmacy in the event of a cartridge failure. Pharmacies were advised to prepare two doses at once so that in the case of a cartridge failure, the site was able to make a second injection attempt right away, without having to prepare a new dose.

Sites were asked to send pictures of failed cartridges and system logs to the device company. They were also asked to send the failed cartridges to the device company for investigation. In some instances, these failures were the result of a manipulation error at the site.

Based upon the manipulation error of one site, additional instructions were sent to all sites to avoid repetition. In addition, at sites where the randomizing of patients had not yet begun, the CRA went to the site to witness the first injection.