Bioject Inc. of Tualatin, Oregon has announced that the CDC is testing its Biojector®2000 intradermal injector as a potential flu vaccine delivery device for young children. The company says that its needle-free injection technology works by “forcing liquid medication at high speed through a tiny orifice that is held against the skin.” We first reported about Bioject’s drug injection systems back in March 2005.
The study is a prospective, phased, randomized, investigator and parent-blinded controlled comparison of therapeutic activity (immunogenicity) and safety/side effects (reactogenicity) in infants and toddlers from 6 to 23 months of age.
The ID route of vaccination is of interest for influenza and other diseases for which vaccines may be in short supply in a pandemic or otherwise unaffordable in developing countries. Prior studies found that reduced doses in the skin often work just as well as full doses injected into fat or muscle. Such “dose-sparing” might extend protection to more people than otherwise would be possible. The influenza pandemic preparedness plans of both the U.S. Government and the World Health Organization have identified such research as a priority.
ID injection by traditional needle method, however, is difficult and requires extra training and experience by health workers to perform correctly. An intradermal spacer on the B2000 injector provides a quick and simple method to deliver such doses. A needle-free system also eliminates other drawbacks of needle-syringes, including needlestick injuries, and in many countries, improper unsterile reuse and unsafe disposal of needle waste.
The CDC decided to use the B2000 because its ID spacer had the most clinical use in adult studies to justify its investigational use in children. Phase I of the still-blinded trial is now complete and its safety results were presented in poster presentation P25 at the 11th Annual Conference on Vaccine Research, in Baltimore, MD, May 2008 (http://www.nfid.org/pdf/conferences/vaccine08abstracts.pdf). An independent Data Safety Monitoring Board reviewed unblinded results from Phase I and deemed the study safe and ethical to proceed to its larger Phase II, which began in April 2008.