Abstract: This disclosure describes the use of solanesol as an adjuvant in vaccine compositions, as well as related prophylactic and therapeutic methods. Solanesol may be used to replace squalene in vaccine compositions with similar or superior immunostimulatory effects. Solanesol, which is solid at room temperature, may be formulated for use in vaccine compositions by heating above its melting temperature in an aqueous solution to form a dispersion.

Abstract: 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.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to noninvasively assess if an alum-containing product, such as a vaccine, has been acceptably resuspended for use following transport and/or storage. This technique allows for the manufacturer and/or distributor and/or end user to monitor for unexpected stressors associated with transport and/or storage including, but not limited to, temperature fluctuations, pH changes, vigorous shaking during transportation, exposure to sunlight, and freezing.

Abstract: The present invention relates to compositions and fusion proteins containing at least two Mycobacterium sp.) antigens, and polynucleotides encoding such compositions and fusion proteins. The invention also relates to methods for their use in the treatment, prevention and/or diagnosis of tuberculosis infections.

Abstract: The invention provides for thermostable lyophilized formulations, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response, and methods of use thereof. The lyophilized formulations generally comprise an antigen and/or an adjuvant, a metabolizable oil, and a cake-forming excipient.

Abstract: Compositions and methods for preventing, treating and detecting leprosy are disclosed. The compositions generally comprise polypeptides comprising one or more Mycobacterium leprae antigens as well as polynucleotides encoding such polypeptides.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to noninvasively assess alum-containing products such as vaccines. This technique can be used for quality control in vaccine manufacturing (e.g., fill-finish step) to determine the evenness of alum filling level as well as extent of alum particle sedimentation in filled and sealed products.

Abstract: Formulations and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed. The formulations generally comprise a TLR4 agonist and a metabolizable oil at a concentration of about 0.01%-1% v/v, wherein the hydrophobic:lipophilic balance (HLB) of the emulsion is greater than about 9.

Abstract: Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier.

Abstract: The present disclosure relates to methods and compositions for treating a active tuberculosis infection and methods and compositions for improving the efficacy of chemotherapy regimens against active tuberculosis infection. The present disclosure relates to methods of treating an active M. tuberculosis infection or an active infection resulting from reactivation of a latent infection in a mammal and to methods of improving the efficacy of chemotherapy regimens against active M. tuberculosis infection.

Abstract: Stable aqueous formulations of adjuvant comprising a TLR7/8 agonist or a TLR4 agonist with a helper lipid that are adsorbed to alum are provided. Compositions and methods of using the formulations for stimulating an immune response are also provided.