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Publication Number
US-9381241-B2
Publication Date
2016-07-05
Expiration Date
Abstract
Problem to be Solved: The present invention provides a novel mucosal adjuvant.Solution: The present invention provides a mucosal adjuvant composition containing at least a composition comprising molecules having a molecular weight in a range of 100 to 300 kDa obtained from cells or culture fluid of Bordetella bronchiseptica. Administration of the mucosal adjuvant composition to a non-human animal at a surface of the mucous membrane can enhance immunity at the surface of mucous membrane. Therefore preventive effects against trans-mucosal infection can be increased by administering an inactivated vaccine against trans-mucosal infection and the mucosal adjuvant composition to a non-human animal at a surface of mucous membrane. The present invention is effective for preventing trans-mucosal infections, including one or more infections of e.g., canine parainfluenza, canine adenovirus, canine coronavirus, canine parvovirus, canine distemper virus, canine herpesvirus, reovirus and pneumovirus.
Core Innovation
The invention relates to a mucosal adjuvant composition comprising molecules obtained from Bordetella bronchiseptica cells or culture fluid. The molecules have a molecular weight in the range of 100 to 300 kDa, and are preferably in the range of 150 to 220 kDa, with a hemagglutinin consistent with an approximately 180 kDa band on SDS-PAGE. These Bordetella bronchiseptica-derived molecules are used as a mucosal adjuvant in trans-mucosal vaccination.
The problem addressed is the need to potentiate mucosal immunity and thereby enhance preventive effects of trans-mucosal vaccines. The Bordetella bronchiseptica-derived mucosal adjuvant composition increases mucosal immune responses when administered to non-human animals at mucous membranes. The mucosal immunity emphasized includes secretory IgA and is described as supporting enhanced prevention of trans-mucosal infection.
In exemplary applications, the mucosal adjuvant is administered together with vaccine antigen to potentiate outcomes after challenge. The disclosure includes intranasal vaccination and transnasal delivery with inactivated vaccines for safety, and it demonstrates reductions in viral titers for inactivated canine vaccines when combined with the mucosal adjuvant. It further reports that trans-mucosal vaccination with adjuvant can reduce clinical symptom scores and supports prevention of Bordetella bronchiseptica infection.
The disclosure also demonstrates mucosal adjuvant activity using ovalbumin (OVA) in guinea pigs. Transnasal adjuvant with OVA is reported to increase anti-OVA IgG and to induce secretory IgA in saliva, rectum, and dejection compared with controls. Overall, the invention centers on Bordetella bronchiseptica-derived 100 to 300 kDa mucosal adjuvant molecules used to enhance mucosal immunity for trans-mucosal vaccination.
Claims Coverage
The independent claim provides a method of preventing canine infectious tracheobronchitis with a mucosal adjuvant composition containing 100–300 kDa molecules obtained from Bordetella bronchiseptica cells or culture fluid, used together with a vaccine antigen against canine adenovirus and canine parainfluenza virus. The dependent claims refine the immune-response effect, delivery route/timing, and the breadth of vaccine antigens.
Preventing canine infectious tracheobronchitis with Bordetella bronchiseptica-derived mucosal adjuvant
Administering to a subject an effective amount of a vaccine antigen against one or more infections of canine adenovirus and canine parainfluenza virus, and a mucosal adjuvant composition comprising molecules having a molecular weight in a range of 100 to 300 kDa obtained from cells or culture fluid of Bordetella bronchiseptica.
Systemic immune response against selected trans-mucosal canine viruses
The administration induces a systemic immune response against a selected trans-mucosal infection from a group comprising canine adenovirus, canine parainfluenza virus, canine coronavirus, canine parvovirus, canine distemper virus, canine herpesvirus, reovirus, and pneumovirus.
Nasal administration of vaccine antigen and mucosal adjuvant
Administering the vaccine antigen and the mucosal adjuvant composition nasally.
Simultaneous administration of vaccine antigen and mucosal adjuvant
Administering the vaccine antigen and the mucosal adjuvant composition simultaneously.
Broadening antigen coverage with multiple vaccine antigens from multiple pathogens
Administering at least two separate vaccine antigens derived from two separate pathogens.
Across the independent and dependent claims, the core inventive concept is the use of Bordetella bronchiseptica-derived 100–300 kDa mucosal adjuvant molecules with a vaccine antigen to prevent canine infectious tracheobronchitis, with refinements that include inducing a systemic immune response against trans-mucosal canine infections, using nasal and/or simultaneous administration, and expanding coverage through multiple vaccine antigens from multiple pathogens.
Stated Advantages
Potentiates mucosal immunity when administered at mucous membranes, including enhancement of secretory IgA.
Enhances preventive effects of trans-mucosal vaccines against trans-mucosal infections.
Reduces viral titers after challenge when used with inactivated canine vaccines.
Reduces clinical symptom scores after challenge with Bordetella bronchiseptica, supporting prevention of infection.
Increases anti-OVA IgG and induces secretory IgA in saliva, rectum, and dejection after transnasal administration.
Documented Applications
A method of preventing canine infectious tracheobronchitis using an inactivated canine parainfluenza virus vaccine antigen with the mucosal adjuvant composition, with reported reduction of virus titers after challenge.
A method of preventing canine infectious tracheobronchitis using an inactivated canine adenovirus type 2 vaccine antigen with the mucosal adjuvant composition, with reported significant decrease of virus titers after challenge.
Intranasal vaccination with the adjuvant plus Bordetella bronchiseptica challenge in dogs, reported to reduce clinical symptom scores and support prevention of B. bronchiseptica infection.
Transnasal adjuvant activity in guinea pigs using ovalbumin (OVA), reported to increase anti-OVA IgG and secretory IgA in saliva, rectum, and dejection.
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