The United States of America, As Represented by the Secretary, Department of Health and Human Services

US Government As Represented by the Secretary of the Army

Howard University

Fiocruz

Che-Hung Robert Lee

Carl E Frasch

Gregory Price

Margaret C Bash

Stanley Shih-Peng Tai

Ellen Jessouroun

Valerian B Pinto

Ivna Alana Freitas Brasileiro Da Silveira

Renata Chagas Bastos

Immunogenic compositions that include a bacterial capsular polysaccharide conjugated to a carrier protein are described. In some embodiments, the bacterial capsular polysaccharide is acapsular polysaccharide. The carrier protein includes anfactor H binding protein (fHbp) linked to cholera toxin subunit B (CTB). Administration of the immunogenic compositions elicits an immune response that includes production of meningococcal polysaccharide-specific and fHbp-specific antibodies. Use of the immunogenic compositions as meningococcal vaccines is also described.

Bacterial polysaccharide-conjugated carrier proteins and use thereof

Disclosed herein are meningococcal immunogenic conjugates which can elicit immune responses against meningococcal polysaccharides (PS) from groups A, C, W-135, and Y and group B factor H binding protein (fHbp). The disclosed conjugates also exhibit bactericidal activity against meningococcal A, C, W-135, Y, B, and X serogroups. Also disclosed are improved methods for preparing conjugates, such as immunogenic conjugates, including activation of a polysaccharide with a cyanylation agent at about 4&#xb0; C.

Multivalent meningococcal conjugates and methods for preparing conjugates

Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Polysaccharide-protein conjugate vaccines

Methods for preparing complex multivalent immunogenic conjugates that include simultaneously reacting a plurality or immunogenic-distinct polysaccharides with at least one protein to make the complex multivalent immunogenic conjugates. The simultaneous reaction involves reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant.

Methods for preparing complex multivalent immunogenic conjugates

Methods for the manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency. Simplified purification processes can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Process for preparing polysaccharide-protein conjugate vaccines

Abstract of the Disclosure Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

This disclosure relates to vaccine formulations comprising an immunogenic composition for inducing antibodies to bothandin a subject. In a preferred aspect, the immunogenic composition comprises covalently conjugated recombinant PsaA ('rPsaA') fromand capsular polysaccharide fromserogroup C. This disclosure further relates to methods for producing the immunogenic composition as well as methods for their use.

Growing community of inventors

Silver Spring, MD, United States of America

Che-Hung Robert Lee