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CDC research scientists have developed a method to identify and quantify the activity of pathogenic bacterial adenylate cyclase toxins by liquid chromatography tandem mass spectrometry (LC-MS/MS). Bacterial protein toxins are among the most potent natural poisons known, causing paralysis, immune system collapse, hemorrhaging and death in some cases.

This CDC developed invention identifies an assay for extremely fast and sensitive detection of Bacillus anthracis lethal toxin (LTx), the toxin responsible for the lethal effects of anthrax infection. This assay has already been successfully tested in animals and will allow for early detection of anthrax exposure and screening of lethal factors to monitor anthrax toxicity, for example for vaccine trial candidates.

CDC researchers have improved upon a prior, HHS patented mass spectrometry-based Endopep-MS assay that is able to rapidly detect and differentiate all seven botulinum neurotoxin (BoNT) types A to G. This current improvement comprises the addition of two optimized substrate peptides that increases the assay's sensitivity,relative to prior substrates, for botulinum neurotoxin type-E (BoNT/E) by greater than 100 fold.

This invention relates to a VAC-BAC shuttle vector system for the creation of recombinant poxviruses from DNA cloned in a bacterial artificial chromosome. A VAC-BAC is a bacterial artificial chromosome (BAC) containing a vaccinia virus genome (VAC) that can replicate in bacteria and produce infectious virus in mammalian cells.

This invention claims Modified Vaccinia Ankara (MVA), a replication-deficient strain of vaccinia virus, expressing Human Immunodeficiency Virus (HIV) env, gag, and pol genes, where the genes are isolated from Ugandan Clade D isolates, Kenyan Clade A isolates, and Tanzanian Clade C isolates. In a rhesus macaque SHIV model, DNA priming followed by a recombinant MVA (rMVA) booster controlled a highly pathogenic immunodeficiency challenge. Both the DNA and the rMVA components of the vaccine expressed multiple immunodeficiency virus proteins.

The current technology relates to the construction, characterization and immunogenicity of modified vaccinia Ankara (MVA) recombinant viruses. The MVA double recombinant viruses express modified/truncated HIV-1 Env and mutated HIV Gag Pol under the control of vaccinia virus early/late promoters. This technology describes the MVA double recombinant viruses made by homologous recombination of single MVA recombinants, one expressing Env and one expressing Gag Pol. These single MVA recombinants are made using a transiently expressed GFP marker that is deleted in the final viruses.

A transmission blocking vaccine developed against malaria contains a recombinant virus, which encodes a unique portion of the sexual stage surface antigen of Plasmodium falciparum (referred to as Pfs25), or the Pfs25 protein purified from infected host cells. Mice inoculated with the recombinant virus developed antibodies capable of blocking transmission of the virus. None of the monoclonal antibodies known to block transmission recognize the reduced Pfs25 antigen. This vaccine, which induces high, long-lasting titers at low cost, can be useful for controlling malaria.

Since the onset of the AIDS epidemic more than two decades ago, enormous efforts have been directed to making a vaccine that will protect against human immunodeficiency virus-1 (HIV); an effective vaccine is thought to require the induction of cellular and humoral responses. Vaccine candidates have included a variety of HIV immunogens delivered as DNA, attenuated poxviruses, adenoviruses, vesicular stomatitis virus, proteins, and various combinations thereof. The inventors' efforts to design an HIV vaccine have focused on modified vaccinia virus Ankara (MVA) as a vector.

The technology offered for licensing is foundational in the area of recombinant DNA vaccines. In the last several years, facilitated through a licensing program of the NIH, the technology has been broadly applied in the development and commercialization of several novel human and veterinary vaccines in the areas of infectious disease as well as cancer therapeutics. The NIH wishes to expand its licensing program of the subject technology in a variety of applications that will benefit public health.

Offered for licensing is a recombinant attenuated vaccinia virus, MVA, that expresses the haemagglutinin (HA) and nucleoprotein (NP) of influenza virus A/PR/8/34 (H1N1). The virus has been shown to stimulate protective immunity to influenza virus in mice.

The materials can be used for research purposes and in particular in the area of influenza virus vaccines.

The related publications listed below demonstrate the usefulness of this biological material in influenza virus vaccine research.