University of Colorado

University of Rochester

Medimmune Limited

Georgetown University

Robert L Garcea

Theodore W Randolph

Alan W Weimer

Robert C Rose

JoAnn A Suzich

Michael P McCarthy

Dennis G Macejak

Renee Finnen

Richard Schlegel

Embodiments of the present disclosure provide novel compositions, methods of use and methods for single composition, multi-dose, thermostable vaccine formulations. In certain embodiments, the present disclosure provides compositions and methods for dehydrating immunogenic agents in the presence of glass-forming agents, and coating the particles formed by the glass-forming agents. In other embodiments, the present disclosure provides for generating compositions for administering an immunogenic composition to a subject multiple times using a single immunogenic composition capable of time-release administration. In other embodiments, single-dose immunogenic agent-containing particles can be directed to two or more pathogens. In other embodiments, incompatible immunogenic agents against two or more different pathogens of immunogenic agent-containing particles disclosed herein can be mixed together and coated for timed-release administration to produce single-administration formulations capable of eliciting an immune response to the two or more pathogens in a subject.

Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens

Embodiments of the present invention provide for novel compositions and methods for making and using a thermally stable human papilloma virus (HPV) formulation or other stabilized multimeric virus formulation. Certain embodiments concern lyophilizing HPV formulations in the presence or absence of adjuvants. Other embodiments concern lypophilizing HPV capsomere vaccines in order to increase stability of an immunogenic composition against HPV infection for storage, delivery and use. In yet other embodiments, a single immunogenic composition can include a thermally stable formulation of multiple virus serotypes. Yet other embodiments disclosed herein concern multi-targeted antigen complexes lyophilized in formulations of use to prolong stability and/or enhance immunogenicity. Other embodiments concern exposing lyophilized multi-targeted antigen complexes to elevated temperatures to enhance immunogenicity of the antigens of the complex to multiple pathogens.

Compositions, methods and uses for thermally stable multi-targeted antigens

Embodiments of the present invention provide compositions and methods for recombinantly generating tagless constructs of proteins or peptides. In certain embodiments, recombinant proteins or peptides disclosed herein concern human papilloma virus (HPV). Other embodiments concern using these constructs in compositions to elicit immune responses in a subject to one or more HPV types. Therapeutic and prophylactic vaccines for the prevention and treatment of viral infections are also disclosed. Nucleic acids and expression vectors coding for constructs contemplated herein are provided. In certain embodiments, an HPV capsid protein generated is devoid of any fusion tags. In addition, truncated forms of HPV L1 are contemplated.

Compositions, methods and uses for improved human papilloma virus constructs

Embodiments of the present invention provide compositions including a complexes of papillomavirus capsid polypeptide L2 and polypeptide including an immunotherapeutic epitope, and GST fusions thereof. Other embodiments also provide complexes comprising chimeras of papillomavirus L2 polypeptides non-covalently associated with papillomavirus L1 polypeptides, and GST fusions thereof. These compositions may be used to elicit immune responses in a patient to papillomavirus. Therapeutic and prophylactic vaccines for the prevention and treatment of viral infection, especially papillomavirus infection and cervical cancers and warts associated therewith, made from compositions of this invention, are also disclosed. Nucleic acids and expression vectors coding for compositions are also disclosed.

Therapeutic and prophylactic vaccine for the treatment and prevention of papillomavirus infection

This invention provides compositions including a chimera of papillomavirus capsid polypeptide L2 and polypeptide including an immunotherapeutic epitope, and GST fusions thereof. The present invention also provides complexes comprising chimeras of papillomavirus L2 polypeptides non-covalently associated with papillomavirus L1 polypeptides, and GST fusions thereof. These compositions may be used to elicit immune responses in a patient to papillomavirus. Therapeutic and prophylactic vaccines for the prevention and treatment of viral infection, especially papillomavirus infection and cervical cancers and warts associated therewith, made from compositions of this invention, are also disclosed. Nucleic acids and expression vectors coding for compositions of this invention are also disclosed.

Novel acetone- or alcohol-fixed viral capsid proteins, bacteria-containing, and papillomavirus L1-GST fusion proteins are described. These proteins are useful in vaccine preparation and as diagnostics.

Stable (fixed) forms of viral capsid proteins, and viral capsid protein fusions, preferably papillomavirus L1 proteins, and uses thereof

The present invention relates to stable HPV capsomeres which express at least one virus-neutralizing conformational epitope of a native HPV L1 protein which are substantially incapable of assembly into virus-like particles. These capsomeres, because of their smaller size, and immunogenic properties are well suited for use in HPV vaccines and as diagnostic agents. Moreover, because of their smaller size (relative to VLPs), these stable capsomeres may be easily purified and should result in HPV vaccines of enhanced homogeneity.

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Boulder, CO, United States of America

Robert L Garcea