Abstract: Provided herein are PEGylated liposomes, and methods of making and using thereof. The PEGylated liposomes comprise at least a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid, wherein the average molecular weight of the PEG component in the PEGylated lipid is about 5000 Daltons or less. The PEGylated liposomes are stable and capable of delivery of an agent for the generation of an immune response, for example an agent for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the PEGylated liposomes and using the PEGylated liposomes for stimulating an immune response are also provided.

Abstract: Provided are methods and compositions for treating and/or preventing C. difficile infections, particularly recurring C. difficile infections. The compositions for use in treating and/or preventing C. difficile infections include in some embodiments at least one agent that inhibits an alpha 2 adrenergic receptor, and the presently disclosed methods include administering at least one such composition to a subject in need thereof, optionally in combination with other therapeutically active agents including but not limited to an enhancer of an IL-13 biological activity, optionally an IL-13 peptide or a fragment or homolog thereof; an interleukin-13 receptor subunit alpha-2 (IL-13Ra2) inhibitor; an enhancer of an Interleukin-33 (IL-33) biological activity, optionally an IL-33 polypeptide or a biologically active fragment or homolog thereof; or any combination thereof.

Abstract: Provided herein are PEGylated liposomes, and methods of making and using thereof. The PEGylated liposomes comprise at least a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid, wherein the average molecular weight of the PEG component in the PEGylated lipid is about 5000 Daltons or less. The PEGylated liposomes are stable and capable of delivery of an agent for the generation of an immune response, for example an agent for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the PEGylated liposomes and using the PEGylated liposomes for stimulating an immune response are also provided.

Abstract: Methods for treating coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, are described. The methods include administration of combinations of agents, including combinations that include dupilumab. The methods can be used to treat subjects diagnosed with a SARS-CoV-2 infection, including those already hospitalized to treat COVID-19 and/or those also having lymphopenia, to reduce the severity of outcomes related to COVID-19, such as admittance to the intensive care unit (ICU), mechanical ventilation, and/or death, particularly over periods of time longer than a month or two months following the initial administration of the agents. Compositions for use in the treatment of COVID-19 are also described.

Abstract: Provided are methods for treating subjects with coronavirus infections. The methods include providing a subject infected with a coronavirus resulting in a prothrombotic condition in addition to being infected by a coronavirus, and administering to the subject an angiotensin (1-7) peptide or an analog or derivative thereof, a Mas Receptor (MasR) agonist, or any combination thereof. The subject may be suffering from COVID-19 disease, including but not limited to a thrombotic complication, an adverse pregnancy outcome, and/or a complication resulting from an underlying prothrombotic state. Also provided are compositions that include Ang (1-7) peptides, analogs, and/or derivatives thereof that are associated with degradable and/or non-degradable polymers having electrostatic interactions therewith, hydrophobic interaction therewith, hydrogen bonding interactions therewith, or any combination thereof.

Abstract: Disclosed are compositions for eliciting anti-SARS-CoV-2 immune responses in subjects. In some embodiments, the compositions include one or more SARS-CoV-2 antigens and one or more PEGylated liposomal adjuvants, wherein at least one of the PEGylated liposomal adjuvants includes a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid. Also provided are methods for using the presently disclosed compositions for stimulating anti-SARS-CoV-2 immune responses, for inducing anti-SARS-CoV-2 Th1 responses, for stimulating systemic immune responses and/or mucosal immune responses, for inducing anti-SARS-CoV-2 IgA responses, for reducing SARS-CoV-2-induced lung injuries, and for inducing anti-SARS-CoV-2 neutralizing antibodies in subjects in need thereof.

Abstract: Methods for treating coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, are described. The methods can be used to reduce the severity of outcomes related to COVID-19, such as hospitalization and ventilation. For example, the methods can involve treatment of a subject with a therapeutic agent that degrades hyaluronan and/or an agent that neutralizes a hyaluronan receptor, e.g., CD44, such as an anti-CD44 antibody.

Abstract: Methods for treating coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, is described. The methods can be used to reduce the severity of outcomes related to COVID-19, such as hospitalization and ventilation. For example, treatment of a subject with a therapeutic agent that neutralizes interleukin 13 (IL-13) can result in reduced risk for mechanical ventilation in the subject. Also described are methods of predicting risk of mechanical ventilation in subjects with COVID-19.

Abstract: Methods and compositions for treating or preventing C. difficile infections, particularly recurring C. difficile infections are described. The compositions for use in treating C. difficile include at least one agent that enhances a biological activity of interleukin-13 (IL-13), such as a recombinant IL-13 peptide or an agent that neutralizes the interleukin-13 (IL-13) decoy receptor, interleukin-13 receptor subunit alpha-2 (IL-13Ra2). Additionally or alternatively, the compositions can include a interleukin-4 (IL-4) peptide. The methods can result in more rapid recovery from CDI and decreased weight loss, e.g., than treatment without the neutralizing agent.

Abstract: Provided herein are PEGylated liposomes, and methods of making and using thereof. The PEGylated liposomes comprise at least a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid, wherein the average molecular weight of the PEG component in the PEGylated lipid is about 5000 Daltons or less. The PEGylated liposomes are stable and capable of delivery of an agent for the generation of an immune response, for example an agent for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the PEGylated liposomes and using the PEGylated liposomes for stimulating an immune response are also provided.

Abstract: Provided herein are PEGylated liposomes, and methods of making and using thereof. The PEGylated liposomes comprise at least a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid, wherein the average molecular weight of the PEG component in the PEGylated lipid is about 5000 Daltons or less. The PEGylated liposomes are stable and capable of delivery of an agent for the generation of an immune response, for example an agent for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the PEGylated liposomes and using the PEGylated liposomes for stimulating an immune response are also provided.

Abstract: Clostridium difficile infection is the leading cause of hospital acquired antibiotic-associated diarrhea in the US (Bartlett, in 2006). The increased prevalence of circulating C. difficile strains poses a significant health threat to US health care facilities. Strains expressing the toxin C. difficile Transferase (CDT), in addition to Toxins A and B (TcdA and TcdB), are more virulent and are associated with higher mortality rates (Bacci et al., 2011). We recently identified a protective role for eosinophils against C. difficile pathogenesis (Buonomo et al., 2016). We have also defined CDT's ability to increase host inflammation and suppress protective eosinophils through a TLR2 dependent mechanism (Cowardin et al., 2016). How CDT promotes virulence and eosinophil suppression via TLR2 is still under investigation.

Abstract: Provided herein are PEGylated liposomes, and methods of making and using thereof. The PEGylated liposomes comprise at least a cholesterol, a non-PEGylated neutral lipid, and a PEGylated lipid, wherein the average molecular weight of the PEG component in the PEGylated lipid is about 5000 Daltons or less. The PEGylated liposomes are stable and capable of delivery of an agent for the generation of an immune response, for example an agent for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the PEGylated liposomes and using the PEGylated liposomes for stimulating an immune response are also provided.

Abstract: Clostridium difficile infection is the leading cause of hospital acquired antibiotic-associated diarrhea in the US (Bartlett, in 2006). The increased prevalence of circulating C. difficile strains poses a significant health threat to US health care facilities. Strains expressing the toxin C. difficile Transferase (CDT), in addition to Toxins A and B (TcdA and TcdB), are more virulent and are associated with higher mortality rates (Bacci et al., 2011). We recently identified a protective role for eosinophils against C. difficile pathogenesis (Buonomo et al., 2016). We have also defined CDT's ability to increase host inflammation and suppress protective eosinophils through a TLR2 dependent mechanism (Cowardin et al., 2016). How CDT promotes virulence and eosinophil suppression via TLR2 is still under investigation.

Abstract: Clostridium difficile is the most common hospital acquired pathogen in the United States, and infection is in many cases fatal. Toxins A and B are its major virulence factors, but increasingly a third toxin may be present, known as C. difficile transferase (CDT). An ADP-ribosyltransferase that causes actin cytoskeletal disruption, CDT is typically produced by the major, hypervirulent strains and has been associated with more severe disease. It is disclosed herein that CDT enhances the virulence of two PCR-ribotype 027 strains in mice. The toxin induces pathogenic host inflammation via a novel Toll-like Receptor 2 (TLR2) dependent pathway, resulting in the suppression of a protective host eosinophilic response. Finally, it is disclosed that restoration of TLR2 deficient eosinophils is sufficient for protection from a strain producing CDT. These findings offer an explanation for the enhanced virulence of CDT-expressing C.

Abstract: The present invention encompasses compositions and methods useful to treat or prevent Clostridium difficile antibiotic-associated colitis through administration of IL-25 and/or downstream cytokines IL-13, IL-4, and IL-5. It is disclosed herein that IL-25 expression is decreased during antibiotic treatment and during bacterial infection and that treatment with IL-25 protein is protective during infection. It is further disclosed herein the unexpected result that IL-25 treatment protects against C. difficile-associated mortality and morbidity. The present application further describes an unexpected result regarding eosinophils and their role in combating infection and their relationship to the effectiveness of IL-25.

Abstract: The present invention encompasses compositions and methods useful to treat or prevent Clostridium difficile antibiotic-associated colitis through administration of IL-25 and/or downstream cytokines IL-13, IL-4, and IL-5. It is disclosed herein that IL-25 expression is decreased during antibiotic treatment and during bacterial infection and that treatment with IL-25 protein is protective during infection. It is further disclosed herein the unexpected result that IL-25 treatment protects against C. difficile-associated mortality and morbidity. The present application further describes an unexpected result regarding eosinophils and their role in combating infection and their relationship to the effectiveness of IL-25.

Abstract: Clostridium difficile is the most common hospital acquired pathogen in the United States, and infection is in many cases fatal. Toxins A and B are its major virulence factors, but increasingly a third toxin may be present, known as C. difficile transferase (CDT). An ADP-ribosyltransferase that causes actin cytoskeletal disruption, CDT is typically produced by the major, hypervirulent strains and has been associated with more severe disease. It is disclosed herein that CDT enhances the virulence of two PCR-ribotype 027 strains in mice. The toxin induces pathogenic host inflammation via a novel Toll-like Receptor 2 (TLR2) dependent pathway, resulting in the suppression of a protective host eosinophilic response. Finally, it is disclosed that restoration of TLR2 deficient eosinophils is sufficient for protection from a strain producing CDT. These findings offer an explanation for the enhanced virulence of CDT-expressing C.

Abstract: The present invention relates to methods for the diagnosis, treatment and prevention of infectious and/or inflammatory diarrhea.

Abstract: The 170 kDa adhesin subunit of the Entamoeba histolytica Gal/GalNAc adherence lectin is encoded by members of a gene family that includes hgl1, hgl2 and a newly discovered gene, hgl3. The DNA and encoded protein sequences of the hgl genes are disclosed. A number of proteins and peptide fragments of the adhesin as well as other functional derivatives, preferably produced by recombinant methods in prokaryotic cells are disclosed. A preferred peptide for a vaccine composition corresponds to amino acids 896-998 of the mature 170 kDa lectin and contains the galactose- and N-acetylgalactosamine-binding activity of the native lectin. These compositions are useful as immunogenic vaccine components and as diagnostic reagents. Methods are provided for a vaccine comprising one or more peptides of the lectin to immunize subjects at risk for infection by E. histolytica. Additionally, immunoassay methods are disclosed for measuring antibodies specific for an epitope of the lectin. These methods detect E.