Abstract: Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11 A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of two of serotypes 1, 3, and 5 and one or both of serotypes 15B and 22F are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM197. Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.

Abstract: The present invention provides, among other things, modified recombinant HA polypeptides with broadened immunogenic profile that extends coverage to antigenically distinct influenza strains and methods of making and using the same.

Abstract: This disclosure relates to methods for eliciting an immune response against C. difficile toxin A and toxin B in an adult human subject. The subject may be at risk for a primary symptomatic C. difficile infection. In some embodiments, a method is for eliciting an immune response against C. difficile toxin A and toxin B in an adult human subject at risk for a primary symptomatic C. difficile infection, and comprises administering to the subject a composition comprising C. difficile toxoid A and toxoid B at least three times, each administration being about seven days apart.

Abstract: The present disclosure relates to a cluster-based consensus approach for generating recombinant hemagglutinin (HA) polypeptides. The disclosure further relates to influenza vaccine compositions comprising the recombinant HA polypeptides.

Abstract: The disclosure provides methods for generating an optimized nucleotide sequence encoding an engineered influenza structural protein and the optimized nucleotide sequences obtained therefrom. The optimized nucleotide sequences can be used in a reverse genetics system to facilitate the rescue of infectious influenza virus containing the engineered structural proteins and/or enhance viral titers. Also provided are methods of preparing an influenza vaccine composition using the optimized nucleotide sequences, as well as methods of inducing an immune response using the influenza vaccine composition.

Abstract: Co-administration (for example, immunogenic cocktail compositions and/or prime boost regimens) of computationally optimized H1N1 influenza hemagglutinin (HA) polypeptides is provided. Coadministration of the optimized H1N1 influenza hemagglutinin (HA) polypeptides facilitates synergistic neutralization of viral infection and provides for improved protective immunity (for example, a broad reactive immune response) to diverse and multiple H1N1 influenza virus strains, including both seasonal and pandemic strains.

Abstract: The present disclosure relates to a cluster-based consensus approach for generating recombinant neuraminidase (NA) polypeptides. The disclosure further relates to influenza vaccine compositions comprising the recombinant NA polypeptides.

Abstract: The present invention provides, among other things, a novel and improved method for generating “mosaic” influenza antigenic polypeptides including hemagglutinin (HA) and neuraminidase (NA) polypeptides based on unique combination of epitope patterns that maximize exposure to epitopes present across multiple HA or NA sequences and therefore improved influenza strain coverage. In particular, the present invention provides engineered influenza B hemagglutinin (HA) polypeptides that are comprised of novel combinations of protective epitopes and antigenic regions from multiple influenza B viral strains. Such engineered HA polypeptides have improved properties over HA polypeptides developed through conventional approaches that rely on consensus alignments of viral sequences.

Abstract: This disclosure relates to methods for eliciting an immune response against C. difficile toxin A and toxin Bin an adult human subject. The subject may be at risk for a primary symptomatic C. difficile infection. In some embodiments, a method is for eliciting an immune response against C. difficile toxin A and toxin B in an adult human subject at risk for a primary symptomatic C. difficile infection, and comprises administering to the subject a composition comprising C. difficile toxoid A and toxoid B at least three times, each administration being about seven days apart.

Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

Abstract: The present invention provides, among other things, a novel and improved method for generating “mosaic” influenza antigenic polypeptides including hemagglutinin (HA) and neuraminidase (NA) polypeptides based on unique combination of epitope patterns that maximize exposure to epitopes present across multiple HA or NA sequences and therefore improved influenza strain coverage. In particular, the present invention provides engineered H1N1 influenza hemagglutinin (HA) polypeptides that are comprised of novel combinations of protective epitopes and antigenic regions from multiple H1N1 viral strains. Such engineered HA polypeptides have improved properties over HA polypeptides developed through conventional approaches that rely on consensus alignments of viral sequences.

Abstract: The present invention provides co-administration (e.g., immunogenic cocktail and/or prime-boost regimens) of computationally optimized H5N1 influenza hemagglutinin (HA) polypeptides that. Co-administration of the optimized H5N1 influenza hemagglutinin (HA) polypeptides facilitates synergistic neutralization of viral infection and provides for improved protective immunity (e.g., a broad reactive immune response) to multiple H5N1 influenza virus clades and strains.

Abstract: Provided herein are compounds, compositions, formulations, kits, uses, and methods for vaccinating a subject against Neisseria meningitidis.

Abstract: The present invention provides co-administration (for example, immunogenic cocktail compositions and/or prime-boost regimens) of computationally optimized H1N1 influenza hemagglutinin (HA) polypeptides. Co-administration of the optimized H1N1 influenza hemagglutinin (HA) polypeptides facilitates synergistic neutralization of viral infection and provides for improved protective immunity (e.g., a broad reactive immune response) to diverse and multiple H1N1 influenza virus strains, including both seasonal and pandemic strains.

Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

Abstract: The present invention provides, among other things, improved influenza vaccines based on hemagglutinins containing one or more alkylated cysteine residues. In particular, the present invention provides influenza vaccines containing hemagglutinins treated with an alkylating agent and methods of making the same. Inventive influenza vaccines provided by the present invention have a remarkable ability to retain potency as determined by Single Radial Immunodiffusion (SRID) assay upon storage.

Abstract: This application relates to the field of prevention of pneumonia by administration of a high-dose influenza vaccine.

Abstract: The disclosure relates to generally to the field of therapeutic and/or protective vaccination against Clostridium dificile (C. difficile). More specifically, it relates to methods for immunizing a host against C. difficile strains expressing C. difficile binary toxin (CDT) and strains not expressing CDT. These methods involve the administration to a host of an immunogenic composition comprising inactivated purified C. difficile Toxin A and purified Toxin B. The purified C. difficile toxins may be derived from a C. difficile strain that does not express CDT.

Abstract: The disclosure relates to generally to the field of toxin inactivation. More specifically, it relates to clostridial toxins, methods of inactivating these toxins and compositions (e.g., vaccines) comprising toxoids (e.g., produced by these methods). Provided are methods of producing a C. difficile toxoid comprising inactivating a C. difficile toxin with formaldehyde. Toxoids prepared by these methods are stable at high temperature (e.g., 37° C.) and remain non-cytotoxic with minimal residual formaldehyde.