Embodiments of immunogens based on the HIV-1 Env fusion peptide and methods of their use and production are disclosed. Nucleic acid molecules encoding the immunogens are also provided. In several embodiments, the immunogens can be used to generate an immune response to HIV-1 Env in a subject, for example, to treat or prevent an HIV-1 infection in the subject.

Disclosed are compositions and virus-like particles (VLPs) self-assembled from the expression of human immunodeficiency virus (HIV) Gag protein and a fragment of gp41 protein containing its N-terminus ectodomain. The fragment of gp41 protein is linked to an antigen that is not a peptide or protein from HIV, which is presented by HIV VLP. In some aspects, the presented antigen is trimerized. Also disclosed are methods of inducing an immune response against the antigen.

Described herein are methods of preventing or treating a HIV infection comprising administering to a mammal in need thereof, a pharmaceutically effective amount of a CD8+ T cell vaccine composition. Such methods comprising using CD8+ T cells which have been pre-stimulated with at least one HIV epitope, to thereby enhance a CD8+ T cell immune response against HIV in said mammal.

HIV neutralizing peptides, sulfated HIV-1 envelope proteins and immunogenic fragments thereof are disclosed, as well as nucleic acids encoding these molecules and methods of producing these peptides, envelope proteins and fragments. Methods are also provided for the treatment or prevention of a human immunodeficiency type 1 (HIV-1 ) infection. The methods can include administering to a subject an HIV neutralizing peptide, sulfated HIV-1 envelope protein or immunogenic fragment thereof as disclosed herein. In several embodiments, administering the HIV neutralizing peptide, sulfated HIV-1 envelope protein or immunogenic fragment generates an immune response in a subject.

The present invention provides a recombinant bacterium and methods of using the recombinant bacterium to induce an immune response.

Embodiments of immunogens based on the outer domain of HIV-1 gp120 and methods of their use and production are disclosed. Nucleic acid molecules encoding the immunogens are also provided. In several embodiments, the immunogens can be used to prime an immune response to gp120 in a subject, for example, to treat or prevent an HIV-1 infection in the subject.

The present invention relates to engineered outer domain (eOD) immunogens of HIV gp120 and mutants thereof and methods of making and using the same. The present invention also includes fusions of eOD to various protein multimers to enhance immunogenicity. The mutant eODs bind to neutralizing antibody precursors. The mutant eODs can activate germline precursors on the pathway to eliciting a broadly neutralizing antibody (bnAb) response. The invention also relates to immunized knock-in mice expressing germline-reverted heavy chains. Induced antibodies showed characteristics of bnAbs and mutations that favored binding to near-native HIV-1 gp120 constructs. In contrast, native-like immunogens failed to activate precursors. The invention also relates to rational epitope design that can prime rare B cell precursors for affinity maturation to desired targets.

The present relation relates to a transgenic Vero cell line expressing CD4 and CCR5. The present invention encompasses the preparation and purification of immunogenic compositions which are formulated into the vaccines of the present invention.

The present disclosure is directed to oral vaccine dosage forms and processes for producing the oral vaccine dosage forms. The dosage forms include lipid-based vesicles (e.g., virosomes, liposomes) harboring an immunogenic amount of at least one vaccinal target molecule, with or without adjuvant. Specifically, Applicants discovered a combination of the composition of the liquid virosome concentrates, the composition of the base matrix for the solid dosage form formulation (excluding the virosome concentrate), and the manufacturing conditions for the dosage forms that can produce a freeze dried sublingual dosage form having physical robustness, particle and antigen integrity and stability.

Embodiments of immunogens based on the outer domain of HIV-1 gp120 and methods of their use and production are disclosed. Nucleic acid molecules encoding the immunogens are also provided. In several embodiments, the immunogens can be used to prime an immune response to gp120 in a subject, for example, to treat or prevent an HIV-1 infection in the subject.