VaxGen and BD to evaluate dermal injection technology for delivery of anthrax vaccine

By Elaine Rigoli

Tampa, Fla., Feb. 21 - VaxGen, Inc. has entered into an agreement with BD (Becton, Dickinson and Co.) on a program to evaluate the potential advantages of using BD's micro injection technology to deliver VaxGen's anthrax vaccine candidate.

Funding will be provided through BD's research contract with the Department of Defense.

The joint program is designed to determine whether dermal administration (injection into the skin) of VaxGen's anthrax vaccine with the patented BD injection technology can enhance the immune response generated by the vaccine versus standard intra-muscular injection, and/or reduce the required amount of vaccine to produce immunity.

If the use of BD's technology in combination with VaxGen's anthrax vaccine proves safe and effective, and is approved by the Food and Drug Administration, it may be considered for use in future generations of VaxGen's recombinant anthrax vaccine as well as other vaccines, according to a company news release.

The evaluation being performed with BD will have no effect on VaxGen's existing contract to deliver 75 million doses of its anthrax vaccine to the U.S. government for civilian biodefense, the company said.

The collaboration will include a phase 1 clinical trial to evaluate the use of BD's Micro Injection technology, featuring a microneedle technology, for vaccination with VaxGen's anthrax vaccine.

Dermal delivery has been studied in combination with a variety of vaccines. BD's Micro Injection technology is designed to easily and reliably deliver vaccine into the dermal layer of the skin with the potential to make dermal vaccination a practical alternative to intramuscular inoculation, the company said.

There is evidence that delivery of vaccines specifically and accurately to the dermal tissue can produce an immune response that is more robust and/or requires less antigen or adjuvant than required with intramuscular inoculation, the release stated.

Under the agreement, VaxGen will be responsible for providing vaccine, conducting clinical studies and regulatory submissions. BD will be responsible for providing devices incorporating the BD Micro Injection technology and for associated regulatory filings. BD will reimburse VaxGen for certain expenses associated with conducting the clinical studies and for serological assays associated with the study.

Based in Brisbane, Calif., VaxGen is a biopharmaceutical company that develops biologic products for the prevention and treatment of human infectious diseases, including anthrax, smallpox and meningitis B.

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