Combination vaccine with acellular pertussis
Inventors
Jain, Rajesh • Singh, Sukhjeet • Jambu, Lavit
Assignees
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Publication Number
US-8551451-B2
Publication Date
2013-10-08
Expiration Date
Abstract
The present invention relates to a combination vaccine comprising a mixture of antigens for protection against diseases such as diphtheria, tetanus, acellular pertussis, and infections caused by Haemophilus influenzae and polio viruses. The present invention also relates to inclusion of antigens for protection against infections caused Hepatitis virus and other pathogens, such that administration of the vaccine can simultaneously immunize a subject against more than one pathogen. The invention in particular relates to a fully liquid stable combination vaccine comprising the antigens as indicated above and the methods for manufacturing the same.
Core Innovation
The invention relates to a fully liquid stable combination vaccine comprising Diphtheria (D), Tetanus (T), acellular pertussis (aP), Haemophilus influenzae (Hib) and Poliovirus (IPV) antigens, wherein Hib is not substantially adsorbed on to any adjuvant. The vaccine is characterized by being fully liquid and stable as described in the document, and Hib is defined as a capsular polysaccharide from the Hib b strain.
For the acellular pertussis component, aP comprises at least one or more antigens selected from Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (P69 or PRN), and Fimbrial proteins (FIM 1, 2 and 3). For the poliovirus component, the IPV antigens are defined as either Salk strains selected from Mahoney type 1, MEF Type 2, and the Saukett type 3, or Sabin strains selected from Sabin 1 or 2.
A further aspect of the invention provides a fully liquid stable combination vaccine comprising D, T, aP, Hib, Hepatitis (Hep) and IPV antigens, with D, T and aP adsorbed on to aluminum phosphate and Hep antigen adsorbed on to aluminum hydroxide. The document also defines options including conjugation of Hib to carrier proteins selected from tetanus toxoid (TT), diphtheria toxoid (DT), CRM 197, and outer membrane protein of Neisseria meningitides.
Claims Coverage
The provided independent claims cover two fully liquid stable combination vaccine compositions. Across these independent claims, the main inventive features are the fully liquid stable formulation concept, specific antigen sets (D/T/aP/Hib/IPV and D/T/aP/Hib/Hep/IPV), adsorption constraints on Hib and on D/T/aP and Hep, and defined sub-antigens for aP plus defined strain options for IPV.
Fully liquid stable combination vaccine with Hib not substantially adsorbed
A fully liquid stable combination vaccine comprising Diphtheria (D), Tetanus (T), acellular pertussis (aP), Haemophilus influenzae (Hib) and Poliovirus (IPV) antigens, wherein Hib is not substantially adsorbed on to any adjuvant.
Fully liquid stable combination vaccine with D, T and aP adsorbed on aluminum phosphate; Hep adsorbed on aluminum hydroxide
A fully liquid stable combination vaccine comprising Diphtheria (D), Tetanus (T), acellular pertussis (aP), Haemophilus influenzae (Hib) and Hepatitis (Hep) and Poliovirus (IPV) antigens, wherein the D, T and the aP antigens are adsorbed on to aluminum phosphate and Hep antigen is adsorbed on to aluminum hydroxide.
Overall, the independent claims focus on fully liquid stable combination vaccines that include D/T/aP/Hib/IPV and D/T/aP/Hib/Hep/IPV, while further restricting component definitions for Hib, aP sub-antigens, and IPV strain options through the dependent claims.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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