NIAID study utilizes Biojector B2000 system to explore syringe, needle benefits

Sep 29 2010

Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free injection therapy systems, today announced that its unique Needle-Free Injection Therapy (NFIT) system, the Biojector^® 2000, is being utilized in a study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the U.S. National Institutes of Health (NIH). The Phase Ib study, called RV262, is evaluating a combination DNA prime/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, Asia and South America. The study is being conducted by the U.S. Military HIV Research Program (MHRP) through its clinical research network in the U.S., East Africa and Thailand.

“We are quite pleased that NIAID has decided to utilize Bioject's B2000 system in order to explore the potential benefits over needle and syringe”

The study will enroll 92 total participants and is designed to assess safety and immune responses. This clinical trial was designed to test a unique prime-boost preventive HIV vaccination strategy aimed at global coverage. The prime is a plasmid DNA vaccine, PENNVAX™-G, and the boost is a virus vector vaccine, Modified Vaccinia Ankara-Chiang Mai Double Recombinant (MVA-CMDR). Together, the vaccines are designed to deliver a diverse mixture of antigens for HIV-1 subtypes A, B, C, D and E.

Taken separately, DNA based and MVA based strategies have been shown to be safe and immunogenic in pre-clinical and clinical trials. Researchers hope they can enhance immune responses by using this prime-boost strategy. Another distinguishing feature of this study is the use of different HIV antigens during the priming (A,B,C,D) and boosting (A/E), which is being studied as a means to increase the breadth of the immune response.

The DNA vaccine was designed in Prof. David B. Weiner's laboratory at the University of Pennsylvania and licensed by Inovio Pharmaceuticals for further clinical product development. The boost vaccine component, based on Modified Vaccinia Ankara (MVA), is a weakened version of the smallpox vaccine that has been used safely and effectively to eradicate that disease worldwide. Researchers at MHRP and NIAID developed the boost.

Historically, DNA vaccine potency has been constrained by the inability to deliver enough DNA into cells, which express the antigens coded by the DNA. To address this, researchers will also test two intramuscular delivery methods for the DNA prime (PENNVAX™-G) to compare their effects on immune response. The two products that will be tested in this study are the Biojector® 2000 and the CELLECTRA® EP (electroporation) device.

"Needle-free injection of a DNA vaccine can provide enhanced immune responses compared with administration by needle and syringe," said Dr. Richard Stout, Executive Vice President and Chief Medical Officer of Bioject. "We are quite pleased that NIAID has decided to utilize Bioject's B2000 system in order to explore the potential benefits over needle and syringe," commented Dr. Stout.

Once the vaccine combination has been assessed as safe and acceptable in twelve HIV-uninfected participants in the U.S., the study will begin at four MHRP sites: Kericho, Kenya; Kampala, Uganda; Mbeya, Tanzania; and Bangkok, Thailand. Twenty healthy, HIV-uninfected participants will be enrolled at each of these sites for a total of 80 international participants.

This clinical trial is a collaboration that includes Bioject Medical Technologies Inc., Inovio Pharmaceuticals, Inc., Henry M. Jackson Foundation for the Advancement of Military Medicine, NIAID and the U.S. Army/MHRP.