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This invention relates to a recombinant, attenuated rabies vaccine that is also capable of inhibiting reproductive fertility. An Evelyn-Rokitnicki-Abelseth (ERA) rabies vaccine backbone, combined with a reproductive-specific protein, such as gonadotropin-releasing hormone (GnRH) or the sperm-binding zona-pellucida-glycoprotein-3 (ZP3) receptor, allows reduction in both rabies transmission and uncontrolled reproduction in stray animals. The ERA rabies vaccine backbone has previously shown strong efficacy in animal studies.

The critical feature of this technology is the Evelyn-Rokitnicki-Abelseth (ERA) rabies whole genome DNA sequence. With the availability of the entire rabies genome, a recombinant vaccine can be developed using reverse genetics. Using this technology, CDC researchers have developed a recombinant, live-attenuated vaccine shown to confer protection against lethal doses of live, street-rabies virus in multiple survival studies. This vaccine offers better protection than traditional inactivated vaccinations, as demonstrated in co-infection studies.

CDC researchers developed a more efficient method of assessing rabies vaccine potency using an antigen-capture electrochemiluminescent (ECL) assay. This assay utilizes SULFO-NHS-Ester labeled murine monoclonal antibodies to quantify glycoprotein concentration, which is an indicator of vaccine potency. Currently, the potency of rabies vaccines is determined by the effective-dose (ED50) mouse study evaluation method, which is more than 50 years old.

CDC researchers have developed recombinant lyssaviruses that can be used for the development of an improved, broad-spectrum vaccine against several rabies genotypes. Lyssaviruses are single-stranded RNA viruses that cause rabies and rabies-like diseases in mammals. Currently, there are commercially available vaccines that are considered to be effective against infections from a single viral phylogroup; however, these vaccines confer little or no protection against viruses outside of the phylogroup.

This invention relates to a genetically modified hemorrhagic fever virus that can be used as an effective live vaccine agent. Hemorrhagic fever evades the human immune response using the viral ovarian tumor domain (vOTU) protease, which inhibits critical host-immunity functions. The present genetically modified virus has a vOTU protease with decreased ability to remove ubiquitin (Ub) and ISG15 tags from proteins in cells it infects. Thus, the virulence is reduced, creating an immunogenic and non-pathogenic virus for use as a live vaccine against Crimean-Congo hemorrhagic fever (CCHF) virus.

The invention provides for a full-length cloned cDNA copy of the RNA genome of a predominant norovirus strain (Genogroup II.4) designated MD145-12 that was associated with human gastrointestinal illness. The noroviruses, which were formerly known as "Norwalk-like" viruses are estimated to cause 23 million cases of acute gastroenteritis in the USA each year. The virus has been designated into category B of the CDC biodefense-related priority pathogens because it can be used as an agent of bioterrorism.

In order to develop a simple detection assay for field use, CDC researchers cloned and sequenced the Taenia solium T24 diagnostic protein. The T24 sequences can be used to detect and diagnose T. solium infection or can be formulated into a pharmaceutical composition. T. solium is a species of tapeworm. Intestinal infection with T. solium is referred to as taeniasis. Many taeniasis infections are asymptomatic but may be characterized by insomnia, anorexia, abdominal pain and weight loss. Cysticercosis infection, which can be fatal, may develop if T.

CDC researchers have developed improved Loop-Mediated Isothermal Amplification (LAMP) assays for the nucleic acid-based diagnosis of malaria in field settings. The approach employs Plasmodium genus-specific LAMP primers and a portable tube scanner to run the LAMP reaction and measure fluorescence signal (e.g., SYBR green) as a measure of DNA amplification in real time. Using this platform, the researchers were able to detect several different species of the human malaria parasites.

CDC scientists developed immunogenic multi-clade, multivalent (HIV1MCMV) recombinant constructs for use as HIV-1 vaccines. These polypeptides include immunogenic CTL, T- and/or B-cell determinants that are capable of eliciting broad and effective immune responses against diverse subtypes of HIV-1. It is believed that these HIV-1 constructs provide universal vaccines, capable of effective use in any part of the world affected by the HIV-1 epidemic.