Neutralizing Monoclonal Antibodies to Botulinum Neurotoxin Type A

Two chimpanzee mAbs specifically reacted with light chain of the botulinum neurotoxin A and neutralize the toxin in the mouse model. They can be used for emergency prophylaxis and treatment of either naturally acquired or terrorist associated botulism. Since the sequence of chimpanzee immune globulin is virtually identical to that of humans, the MAbs are not expected to have problems in repeated administration as equine antibodies. They can also be used for rapid diagnosis of botulinum neurotoxin A.

Swine Hepatitis E Virus Available For Use in Diagnosis, Prevention and Treatment of Hepatitis E

Hepatitis E virus (HEV) is the cause of Hepatitis E, a liver disease that occurs primarily in developing countries due to fecal contaminated drinking water. Outbreaks of HEV infection have caused epidemics in Africa, Central and Southeast Asia and Mexico and cases of the disease have also been reported sporadically in more developed countries. Hepatitis E is most often overcome by a host’s natural defenses; however the disease is more severe in pregnant women, who exhibit a 20% mortality rate due to HEV infection.

A Varicella-Zoster Virus Mutant that is Markedly Impaired for Latent Infection Available for the Development of Shingles Vaccines and Diagnostics

Reactivation of latent Varicella-Zoster virus (VZV) infection is the cause of shingles, which is prominent in adults over the age of 60 and individuals who have compromised immune systems, due to HIV infection, cancer treatment and/or transplant. Shingles is a worldwide health concern that affects approximately 600,000 Americans each year. The incidence of shingles is also high in Europe, South America, and India; the latter having an estimated two million individuals affected, yearly.

Novel System for HIV-1 Vaccine Development

The available technologies describe specific immunogenic peptides, peptide modifications and methods for identifying additional immunogens against HIV-1 surface proteins, gp120 and gp41. Additionally, detailed methods for use of the described immunogenic peptides in the development of vaccines and diagnostics for HIV-1 are disclosed. The current technologies further include a comprehensive system for immunogen design, comprising in silico design coupled to feedback from X-ray crystallography, antigenic analysis, and immunization.

High Level Expression and Purification of Untagged and Histidine-tagged Human Immunodeficiency Virus Type-1 Reverse Transcriptase

Human immunodeficiency virus type-1 reverse transcriptase (HIV-1 RT) gene encodes 560 amino acids. In the virus, however, HIV-1 RT occurs as a dimer of two related polypeptides, p66 and p51 subunits at a molar ratio of 1:1. The p51 subunit is derived from a C-terminal proteolytic cleavage of the p66 subunit. This invention describes a simplified protocol to purify large quantities of histidine-tagged and untagged heterodimeric forms of human immunodeficiency virus type-1 reverse transcriptase (HIV-1 RT) from Escherichia coli.

Codon Optimized Genes for Subunit Vaccines

Available for licensing from the NIH are gene constructs that express immunogenic proteins based on viral genes that have been optimized for expression in mammalian cells. Using vaccine vectors expressing respiratory syncytial virus (RSV) proteins from the optimized genes, this technology was shown to result in a potent RSV-specific cellular immune responses with favorable phenotypic patterns. This technology was shown to generate a superior immune (both humoral and cellular) response when utilized as part of a heterologous vector prime-boost regimen.

Methods for Prevention and Treatment of Polyomavirus Infection or Reactivation

Available for licensing and commercial development are methods of using two MAP kinase kinase (MEK) inhibitors, PD98059 and U0126, in the prevention and treatment of polyomavirus infection. Decrease in viral protein expression upon treatment with the MEK inhibitors has been demonstrated for two polyomavirus species, JC virus (JCV) and BK virus (BKV). It is believed that these MEK inhibitors may also be effective against other polyomavirus species in which TGF-beta expression is elevated.

Monoclonal Antibodies that Neutralize <i>B. anthracis</i> Protective Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)

Anthrax, whether resulting from natural or bioterrorist-associated exposure, is a constant threat to human health. The lethality of anthrax is primarily the result of the effects of anthrax toxin, which has 3 components: a receptor-binding protein known as "protective antigen" (PA) and 2 catalytic proteins known as "lethal factor" (LF) and "edema factor" (EF). Although production of an efficient anthrax vaccine is an ultimate goal, the benefits of vaccination can be expected only if a large proportion of the population at risk is immunized.

Development of Dengue Virus Type 3 Vaccine Candidates

The disease burden associated with dengue virus infection has increased over the past several decades in the tropical and semi-tropical regions of the world, where over 2 billion people live at risk of dengue infection. Annually, there are an estimated fifty (50) to one hundred (100) million cases of dengue fever, making development of an effective vaccine a priority. In addition, there is a need for a "travelers vaccine" to protect those visiting dengue virus endemic areas, similar in scope to other currently available "travelers vaccines", such as hepatitis A vaccine.