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Biotech / Medical : BJCT-BIOJECT-needle less injection product

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To: geewiz who wrote (380)4/14/1999 8:26:00 PM
From: Marc Kahn  Read Replies (1) of 534
 
The following is transcribed from the abstract of a clinical test, dated November 1998. It shows that jet injection is significantly more effective than needle/syringe in delivering Hepatitis A vaccine.

Please note that this is NOT a DNA based vaccine. There were 460 participants in this test, 300 of whom were sero-negative at the beginning, and therefore received injections.

Hopefully, next month, we will be getting similar results from the CDC sponsored test of flu vaccine which took place last fall at the University of Washington in Seattle.

Marc Kahn

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Injection Method on HAV Antibody Formation

L. Fox-Leyva, J. Williams, C.Christensen, D. Fisher, E. Schlichting, M. Snowball, S. Negus, M. Getty, H. Peters, R. Koller, J. Mayers, K. Wainwright, and R. Stout

Alaska Native Medical Center, Anchorage, Alaska

Abstract: A randomized trial to compare the effectiveness of 2 different injection systems: Jet-Injection (Biojector) vs. needle and syringe using an inactivated hepatitis A vaccine (Havrix, SmithKline Beecham) in healthy hospital employees.

Methods: All participants who were sero negative (HAV IgG neg.) received a licensed dose of 1440 ELA units at month 0 and 6. At day 15, 30 and month 7, an HAV IgG titer was drawn. Prior to vaccination participants were randomized into 2 groups, one to receive vaccine by needle/syringe and the other by Jet-Injection (Biojector).

Results: The day 15 combined seroconversion rate was 83%. The incidence of seroconversion at day 30 was 7% higher in the Biojector group than in the needle/syringe group (93% vs 86%). The slope of the rise and the titers were greater at each point in time. To determine if significant differences in antibody formation exist, the injection methods (Biojector or needle) were compared using t-tests for each point in time. The results indicate the Biojector elicits a significantly greater GMT of HAV antibodies when compared to needle injection. Results are displayed in corresponding charts and tables.

Conclusions: The results of this study demonstrate that HAV vaccine administered vis the Biojector intiates a superior HAV immune response (p<.001) when compared with needle injection at day 30. The (GMT) Geometric Mean Titer, of the Biojector as compared to the needle injection, was greater at each point in time; 33% greater at day 15, 58% greater at day 30, and 18% greater at month 7.

The present study appears to validate the use of jet injection for administration of hepatitis A vaccine (HAVRIX).

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