Vaccine formulations comprising preservative
Inventors
SANGAREDDY, VEERAPANDU • Burki, Rajendar • Sriraman, Rajan • Matur, Ramesh Venkat • Mantena, Narender Dev • Datla, Mahima
Assignees
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Publication Number
US-12318437-B2
Publication Date
2025-06-03
Expiration Date
Abstract
The present invention relates to vaccine formulations comprising preservative systems. More particularly, the present invention relates to preservative systems for vaccine formulations which is free of thiomersal, and comprising 2-phenoxyethanol and at least one other preservative selected from m-cresol, benzyl alcohol, phenol and benzoic acid.
Core Innovation
The invention relates to a thiomersal-free vaccine preservative system for multidose vaccines. The formulation includes an antigen together with a preservative system comprising 2-phenoxyethanol (2-PE) combined with at least one additional preservative selected from m-cresol, benzyl alcohol, phenol, and benzoic acid. The preservative system is used at low concentrations intended to maintain antimicrobial effectiveness while remaining compatible with vaccine antigen content.
The core formulation described includes 2-PE at about 0.1% to 0.6% together with m-cresol at low concentrations. Additional preservative options include benzyl alcohol, phenol, and benzoic acid with specified low concentration ranges when included. The invention further describes vaccine formulations that include monovalent or multivalent antigens, including pneumococcal conjugate antigens.
The invention includes specific pneumococcal capsular polysaccharide protein conjugates comprising Streptococcus pneumoniae capsular polysaccharides selected from defined serotypes and conjugated to carrier proteins. The document also reports preservative efficacy data using USP/PET-style preservative efficacy testing, including antimicrobial effectiveness across test microorganisms spanning bacteria, yeast, and fungi. Immunogenicity is addressed by comparison to a preservative-free control in a rabbit immunization context, reporting serum antibody titers.
Claims Coverage
The partial content provides one independent claim. This independent claim specifies the core preservative system comprising 2-phenoxyethanol and m-cresol at defined concentration ranges in a vaccine formulation comprising an antigen, and it is supported by dependent claims that add further preservative components and constrain the antigen/vaccine types.
Thiomersal-free vaccine formulation with 2-phenoxyethanol and m-cresol preservative system
A vaccine formulation comprising an antigen and a preservative system comprising 2-phenoxyethanol at a concentration in the range of 0.1% to 0.2% and m-cresol at a concentration in the range of 0.005% to 0.05%.
Pneumococcal capsular polysaccharide protein conjugates with defined serotypes and carrier proteins
A vaccine formulation comprising pneumococcal capsular polysaccharide protein conjugates, wherein Streptococcus pneumonia capsular polysaccharides are selected from specified serotypes and each polysaccharide is conjugated to one of the listed carrier proteins.
Specific pneumococcal conjugate valency selections (14-valent, 20-valent, or 24-valent)
A vaccine formulation is selected to be one of specific pneumococcal 14-valent, 20-valent (with two alternative serotype sets), or 24-valent pneumococcal capsular polysaccharide protein conjugate vaccines comprising capsular polysaccharides from listed Streptococcus pneumoniae serotypes.
Across the provided claim set, the coverage centers on a vaccine formulation that uses an antigen with a preservative system containing 2-phenoxyethanol and m-cresol at defined concentration ranges, with dependent claims further covering defined pneumococcal conjugate constructions and selected pneumococcal valency/serotype sets.
Stated Advantages
Provides preservative efficacy against test microorganisms in a multidose context as indicated by preservative efficacy testing data.
Shows no negative effect on immunogenicity, with serum antibody titers comparable to a preservative-free control in rabbit immunization.
Documented Applications
Multidose vaccine formulations, including thiomersal-free vaccine preservative systems.
Vaccine antigen formulations including monovalent and multivalent combination vaccines, including pneumococcal conjugate antigen formulations.
Rabbit immunization use context to compare serum antibody titers between preservative-containing and preservative-free formulations.
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