CDC presents clinical trial results of Biojector 2000 at 13th Annual Conference on Vaccine Research

Apr 30 2010

Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free injection therapy systems (NFITS), today announced that the Centers for Disease Control and Prevention (CDC) and its collaborating institutions presented the latest results of its clinical trial of the Biojector® 2000 at the 13th Annual Conference on Vaccine Research, sponsored by the National Foundation for Infectious Diseases and held in Bethesda, Maryland April 26 - 28, 2010. The study involved administering influenza vaccine intradermally in reduced "dose-sparing" amounts into the skin by jet injection, increasing the speed and avoiding the risks and discomfort of the traditional "Mantoux" needle method commonly used for tuberculosis skin testing.

“We are very pleased to have participated in this study evaluating influenza vaccine given intradermally with a dose sparing regimen. The intradermal delivery of reduced doses of vaccine could help countries with limited resources vaccinate a larger percentage of their population while eliminating the hazards of needle-syringe delivery”

The threat of pandemic influenza and other diseases will likely require mass campaigns in which a limited number of healthcare workers would need to rapidly vaccinate large populations. The intradermal route takes advantage of the high immune responsiveness of the skin to reduce the amount of vaccine needed for influenza and some other vaccines. Intradermal delivery may extend protection to larger numbers than would full doses of expensive or scarce vaccines. The traditional intradermal method by needle-syringe is difficult and tedious. Jet injectors can vaccinate into the skin more quickly and also eliminate many of the dangers and drawbacks of using needle-syringe delivery, such as intentional or inadvertent unsterile reuse, needle-stick injuries to healthcare workers, and improper disposal of sharps waste.

The trial was conducted in a dedicated study center at the Hospital Infantil Dr Robert Reid Cabral, a public, tertiary-care, pediatric teaching hospital in the Dominican Republic capital, with study oversight and involvement by the CDC, the World Health Organization, and PATH.

The study enrolled 450 participants, ages ranging from 6 to 24 months. Each participant received two doses, four weeks apart, of influenza vaccine randomized into three groups: One-third of the children received 0.1 mL intradermally with the Biojector® 2000; one-third 0.1 mL intramuscularly by needle/syringe, and one-third the conventional full-dose of 0.25 mL intramuscularly by needle/syringe. Overall local adverse events were mild and tolerable, and immune responses were generally good. Definitive assessment awaits unblinded analysis by group of all participants. Details about the study are publicly available at: http://www.clinicaltrials.gov/ct2/show/NCT00386542.

"We are very pleased to have participated in this study evaluating influenza vaccine given intradermally with a dose sparing regimen. The intradermal delivery of reduced doses of vaccine could help countries with limited resources vaccinate a larger percentage of their population while eliminating the hazards of needle-syringe delivery," said Dr. Richard Stout, Bioject's Executive Vice President and Chief Medical Officer.

SOURCE Bioject Medical Technologies Inc.,