Provided herein are nanostructured lipid carrier compositions, and methods of making and using thereof. The compositions comprise a nanostructured lipid carrier (NLC), where the NLC comprises an oil core comprising a mixture of a liquid phase lipid and a solid phase lipid, a cationic lipid, a sorbitan ester, and a hydrophilic surfactant, and optionally a bioactive agent. The bioactive agent can be associated with the NLC. The compositions are capable of delivery of a biomolecule to a cell for the generation of an immune response, for example, for vaccine, therapeutic, or diagnostic uses. Compositions and methods related to making the compositions and using the compositions for stimulating an immune response are also provided.

Disclosed herein are methods of using immunomodulatory sterols as vaccine adjuvants. Accordingly, certain embodiments relates to pharmaceutical compositions containing at least one antigen and at least one immunomodulatory sterol; and, methods of inducing an immunomodulatory response in a patient by administering an immunomodulatory-effective amount of at least one immunomodulatory sterol.

Disclosed herein are methods of using immunomodulatory sterols as vaccine adjuvants. Accordingly, certain embodiments relates to pharmaceutical compositions containing at least one antigen and at least one immunomodulatory sterol; and, methods of inducing an immunomodulatory response in a patient by administering an immunomodulatory-effective amount of at least one immunomodulatory sterol.

The present invention provides methods for improving observed or determined efficacy by administration of agents to more severely diseased subjects, as contrasted with less severely diseased subjects. The present disclosure specifically demonstrates that, with respect to treatment of certain skin conditions, and particularly conditions associated with dysregulated and/or diseased skin cells, administration to more severely diseased subjects improves observed or determined efficacy.

Anti-parasitic compounds and uses thereof. Compounds comprising a C-terminal peptide adjuvant conjugated to an N-terminal peptide antigen via a protease-cleavable linker, said peptide adjuvant comprising a peptide analog of C5a, wherein said peptide antigen comprises an antigenic epitope of a parasitic organism, such as T. gondii. Methods of therapeutic or prophylactic treatment of a parasitic infections.

Anti-parasitic compounds and uses thereof. Compounds comprising a C-terminal peptide adjuvant conjugated to an N-terminal peptide antigen via a protease-cleavable linker, said peptide adjuvant comprising a peptide analog of C5a, wherein said peptide antigen comprises an antigenic epitope of a parasitic organism, such as T. gondii. Methods of therapeutic or prophylactic treatment of a parasitic infections.

The present invention provides methods for improving observed or determined efficacy by administration of agents to more severely diseased subjects, as contrasted with less severely diseased subjects. The present disclosure specifically demonstrates that, with respect to treatment of certain skin conditions, and particularly conditions associated with dysregulated and/or diseased skin cells, administration to more severely diseased subjects improves observed or determined efficacy.

The present invention provides vaccines and compositions, methods and uses of immunogenic vaccine compositions for eliciting an immune response to members of trypanosomatids such as Trypanosoma brucei, T. cruzi and Leishmania species.

The present invention provides vaccines and compositions, methods and uses of immunogenic vaccine compositions for eliciting an immune response to members of trypanosomatids such as Trypanosoma brucei, T. cruzi and Leishmania species.

The present invention encompasses vaccines or compositions comprising the chimeric KSAC protein that possesses immunogenic and protective properties, and methods of use including administering to an animal the antigenic KSAC protein thereof to protect animals. The invention also encompasses methods for making and producing the soluble, disaggregated, refolded or active proteins from inclusion bodies produced from prokaryotes or eukaryotes.