Heartland Virus Humanized Monoclonal Antibodies for Diagnostic and Therapeutic Development

Heartland virus (HRTV) is a novel tick-borne virus first discovered in 2009 that causes flu-like symptoms such as fever, headaches, fatigue, muscle aches, and diarrhea. Patients with HRTV often have low white blood cell counts, low platelet counts, and abnormal liver function tests which can become severe. Cases of Heartland virus disease have been identified in the Midwestern and southern United States. There are no vaccines to prevent or medications to treat Heartland virus infections.

Zika Virus NS1 Protein Monoclonal Antibodies for Research, Development, and Novel Diagnostics

Zika virus is a flavivirus that is spread by the bite of infected Aedes mosquitoes. The current outbreak and swift dissemination/spread of Zika virus (ZIKV) and its linkage to birth defects and neurological syndromes has prompted the development of novel diagnostic tests. Because ZIKV is serologically similar to other flaviviruses such as dengue virus (DNV), cross-reactivity occurs in diagnostic tests and can result in misdiagnoses. This is especially evident in populations that live in dengue-endemic regions or have received heterologous flaviviral vaccines (i.e., yellow fever 17D).

Monoclonal Antibodies for Specific Detection of Dengue Virus Sub-type 4 in Human Serum

Dengue Virus (DENV) non-structural protein 1 (NS1) is secreted in blood during the acute phase of viremic DENV infection. While there are commercially available ELISA assays for DENV NS1 detection, these tests have limited sensitivity (50-70%), do not determine the serotype of the infecting DENV, do not detect all four serotypes equally, or are less sensitive in subsequent DENV infections. There is a critical need for serotype specific diagnostics to inform public health and potentially clinical care interventions.

Novel Fourth Human Ebolavirus species, <em>Bundibugyo ebolavirus</em> – Compositions and Methods for Vaccine, Therapeutics and Highly Sensitive Diagnostic Assay Development

Ebola Virus Disease (EVD) is a disease caused by infection with viruses from the family Filoviridae, genus Ebolavirus. Ebola virus was first discovered in 1976 in Africa and has since caused numerous outbreaks throughout the continent including the largest outbreak in history in West Africa during 2014-2016. Previously, there were three identified Ebolavirus species which were known to cause disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); and Tai Forest virus (Tai Forest ebolavirus).

Novel Peptide of <em>Streptococcus pneumoniae</em> Surface Adhesion A (PsaA) Protein Associated with Adherence and Uses Thereof – for Vaccine Candidate, Therapeutic and Diagnostic Development

Streptococcus pneumoniae (S. pneumonia), bacteria commonly referred to as pneumococcus, are a significant cause of disease resulting in 1.5 million deaths every year worldwide according to the World Health Organization. The major types of pneumococcal disease are pneumonia (lung infection), bacteremia (bloodstream infection), and meningitis (infection of the tissue covering of the brain and spinal cord). Less severe pneumococcal illnesses include ear and sinus infections.

New Anti-Influenza Virus Neuraminidase 9 (N9) Monoclonal Antibody – for Prevention or Treatment of H7N9 Influenza (Flu) A with Less Likelihood of Drug Resistance

H7N9 influenza viruses are predominately avian (bird) pathogens, however, since 2013, they have infected more than 1500 humans with a mortality rate of nearly 40% in confirmed cases. H7N9 viruses continue to be a threat to public health. Treatment for people infected with H7N9-subtype influenza A (H7N9) commonly includes the use of drugs that inhibit neuraminidase, a protein found on the virus’ surface. However, like other influenza viruses, H7N9 can become resistant to these drugs.

Assay for Early Diagnosis of Anthrax Using Monoclonal Antibodies Against Anthrax Toxin

Anthrax is a serious infectious disease caused by bacteria known as Bacillus anthracis. Anthrax-contaminated spores can be found naturally in soil and they commonly affect domestic and wild animals around the world. Although rare in the United States, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products.

Antibodies for Rabies Post-exposure Prophylaxis or Antiviral Therapy of Clinical Rabies

Lyssaviruses are single-stranded RNA viruses that cause rabies and rabies-like diseases in mammals. According to the World Health Organization, human rabies caused by the classical rabies virus continues to be almost 100% fatal once clinical symptoms of rabies appear, with no specific treatment available anywhere in the world.

Licensing Availability: Methods of Diagnosing and Treating CHAPLE, A Newly Identified Orphan Disease

This technology is directed towards a potential treatment for a new disease, CHAPLE (Complement Hyperactivation, Angiopathic thrombosis, and Protein-Losing Enteropathy), identified by NIAID researchers. CHAPLE is associated with GI symptoms and vascular thrombosis and is caused by loss-of-function variants in the gene encoding the complement regulatory protein CD55. The disease is caused by enhanced activation of the complement pathway and complement-mediated induction of intestinal lymphangiectasia and protein-losing enteropathy.

Cardiolipin Modification for Immunoassay Detection of Syphilis

Syphilis is a sexually transmitted disease (STD) that remains a global health threat. Syphilis rates in the United States have also been increasing. Left untreated, syphilis infection can span decades and have serious complications including blindness, dementia and paralysis. Syphilis in pregnancy causes prematurity, low birthweight, neonatal death, and infections in newborns. Improvements in syphilis detection are needed to facilitate early diagnosis of active infections and monitor treatment with antibiotics.