Meningococcal and pneumococcal conjugate vaccine and method of using same
Inventors
Tai, Stanley Shih-Peng • Lee, Che-Hung Robert
Assignees
Howard University • Office of Technology Transfer
Publication Number
US-8003112-B2
Publication Date
2011-08-23
Expiration Date
2029-04-16
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Abstract
This disclosure relates to vaccine formulations comprising an immunogenic composition for inducing antibodies to both S. pneumoniae and N. meningitides in a subject. In a preferred aspect, the immunogenic composition comprises covalently conjugated recombinant PsaA (“rPsaA”) from S. pneumoniae and capsular polysaccharide from N. meningitidis serogroup C. This disclosure further relates to methods for producing the immunogenic composition as well as methods for their use.
Core Innovation
This invention provides an immunogenic composition comprising an isolated capsular polysaccharide from Neisseria meningitidis serogroup C, covalently conjugated to recombinant pneumococcal surface antigen A (rPsaA) from Streptococcus pneumoniae. The composition induces antibodies to both S. pneumoniae and N. meningitidis in a subject, providing dual protection against infections by these pathogens. PsaA acts simultaneously as an antigen and a carrier protein for the meningococcal capsular polysaccharide, enhancing the immunogenicity of the vaccine.
The problem addressed relates to the limitations of existing pneumococcal and meningococcal vaccines. Pneumococcal vaccines are serotype-specific due to capsular polysaccharide antigens and have limited efficacy, especially in children under two years old, with current conjugate vaccines covering limited serotypes and being costly and in limited supply. Meningococcal vaccines also face efficacy issues in young children and affordability problems for developing countries. Current vaccines target either S. pneumoniae or N. meningitidis separately, necessitating multiple immunizations.
This invention solves these issues by combining capsular polysaccharide from meningococcal serogroup C with pneumococcal rPsaA in a conjugate vaccine. The conjugate significantly increases immunogenicity—exceeding 40-fold for PsaA and over 170-fold for the capsular polysaccharide compared to non-conjugated forms—and enables a single vaccine formulation to provide effective immune responses to both pathogens. The composition can be administered via multiple routes and formulated with pharmaceutically acceptable diluents, carriers, and adjuvants, offering advantages in cost reduction and broader protection, particularly benefiting underdeveloped and developing countries burdened by pneumococcal and meningococcal diseases.
Claims Coverage
The patent discloses five claims, of which two independent claims establish the core inventive features of the immunogenic composition and its method of use.
Immunogenic composition comprising conjugated serogroup C meningococcal polysaccharide and pneumococcal surface antigen A
An immunogenic composition comprising isolated capsular polysaccharide from Neisseria meningitidis serogroup C covalently conjugated to purified pneumococcal surface antigen A (PsaA) of 309 amino acid residues, which generates a murine serum IgG response against both antigens greater than the response generated by the non-conjugated forms when administered in an immunogenically effective amount.
Immunogenic composition using recombinant PsaA including amino acid residues 21 to 319 of SEQ ID NO:1
The immunogenic composition as above wherein the PsaA is recombinant and comprises at least amino acid residues 21 to 319 of SEQ ID NO:1, generating an enhanced murine serum IgG response to both the serogroup C polysaccharide and PsaA compared to their non-conjugated forms.
Pharmaceutically acceptable formulation of the immunogenic composition
The immunogenic composition may further include pharmaceutically acceptable diluents, carriers, adjuvants, and/or buffers to formulate the vaccine.
Induction of bactericidal immune response against meningococcal serogroup C
The immunogenic composition elicits a bactericidal immune response in mice against serogroup C Neisseria meningitidis.
Method of administering the immunogenic composition
A method comprising administering to a subject an effective amount of the immunogenic composition to induce an immune response against both Neisseria meningitidis serogroup C and pneumococcal surface antigen A.
The independent claims collectively cover the conjugate vaccine comprising conjugated meningococcal serogroup C polysaccharide and recombinant pneumococcal PsaA protein, its enhanced immunogenic effect compared to non-conjugated antigens, pharmaceutically acceptable formulations, bactericidal activity, and methods of administration to elicit protective antibody responses.
Stated Advantages
Provides dual protection against S. pneumoniae and N. meningitidis infections in a single vaccine formulation.
Significantly increases immunogenicity of both antigens compared to individual non-conjugated components.
Enables long-lasting immunity with immune memory effective for infants and young children.
Reduces costs of vaccine preparation and administration, benefiting developing and underdeveloped countries.
PsaA acts as both an antigen and carrier protein, simplifying vaccine composition.
Documented Applications
Prevention of infection by S. pneumoniae and N. meningitidis serogroup C, including diseases such as otitis media and meningitis in young children.
Prevention of pneumococcal and meningococcal diseases such as bacteremia, pneumonia, and meningitis in various age groups.
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