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Publication Number
US-11406704-B2
Publication Date
2022-08-09
Expiration Date
Abstract
The present disclosure provides novel adjuvants which may be used in combination with one or more antigens to augment, modulate or enhance a host immune response to the one or more antigens. The adjuvants are based on sialic acid binding molecules and may be combined with any type of antigen. The adjuvants may be formulated for mucosal and/or intranasal administration.
Core Innovation
The disclosure relates to mucosal adjuvants comprising sialic acid binding molecules that bind sialic acid and augment an immune response to a co-administered antigen. The approach improves an immune response by administering a composition comprising the antigen and a molecule capable of binding sialic acid, wherein the molecule capable of binding sialic acid is an adjuvant which improves the immune response to the antigen.
The sialic acid binding molecule adjuvant comprises two or more family 40 carbohydrate binding modules. The disclosure further defines multivalent carbohydrate binding module constructs and oligomerisation or trimerisation domains, including constructs involving carbohydrate binding modules from Vibrio cholerae NanH and Streptococcus pneumoniae NanA.
The disclosure describes specific adjuvant constructs and combinations of domains, including multivalent constructs that incorporate a Pseudomonas aeruginosa pseudaminidase trimerisation domain (TD), including Vc2CBMTD and Sp2CBMTD. The described framework supports mucosal and systemic immune outcomes following mucosal or intranasal vaccination, including mucosal immune responses such as IgA and systemic immune responses such as IgM and IgG.
Claims Coverage
The independent claim covers co-administration of an antigen and a sialic acid binding adjuvant in a human or animal subject, where the sialic acid binding molecule comprises two or more family 40 carbohydrate binding modules. Dependent claims specify particular adjuvant construct components, attachment formats, and mucosal immune response context, with 6 inventive features represented across the items.
Improving an immune response with a sialic acid binding adjuvant comprising two or more family 40 carbohydrate binding modules
Administering a composition comprising the antigen and a molecule capable of binding sialic acid to a human or animal subject, wherein the molecule capable of binding sialic acid is an adjuvant which improves the immune response to the antigen, and wherein the molecule capable of binding sialic acid comprises two or more family 40 carbohydrate binding modules.
Vc2CBMTD adjuvant formed by fusing binding domains from Vibrio cholerae NanH to a pseudaminidase trimerisation domain
The method wherein the molecule capable of binding sialic acid comprises a Vc2CBMTD adjuvant formed by fusing, binding, or conjugating two sialic acid binding domains from Vibrio cholerae NanH sialidase (Vc2CBM) to a Pseudomonas aeruginosa pseudaminidase trimerisation domain (TD).
Streptococcus pneumoniae NanA amino acid sequence for the sialic acid binding adjuvant ingredient
The method wherein the molecule capable of binding sialic acid comprises a Streptococcus pneumoniae NanA sialidase amino acid sequence corresponding to SEQ ID NO: 3 or SEQ ID NO: 4.
Producing a mucosal immune response
The method further characterised by producing a mucosal immune response.
Fused, linked, or conjugated sialic-acid binding molecule to the antigen
The method wherein a sialic-acid-binding molecule is fused, linked, or conjugated to the antigen.
Fusing the sialic-acid binding molecule to an internal region and/or N-terminal and/or C-terminal regions of the antigen
The method further includes fusing a sialic-acid-binding molecule to an internal region and/or to the N-terminal and/or C-terminal region of an antigen.
The coverage centers on co-administration of an antigen with a sialic acid binding adjuvant comprising two or more family 40 carbohydrate binding modules, with further narrowing to specific multivalent constructs, SEQ ID-defined NanA sequences, and defined formats for attaching the sialic-acid binding molecule to the antigen in the context of producing a mucosal immune response.
Stated Advantages
Improves the immune response to the antigen.
Produces a mucosal immune response.
Supports enhanced antibody levels against the carbohydrate binding module and the test antigen in the disclosed experiments [procedural detail omitted for safety].
Documented Applications
Mucosal or intranasal vaccination with a co-administered antigen and a sialic acid binding molecule adjuvant to induce mucosal immune responses (IgA) and systemic immune responses (IgM/IgG) [procedural detail omitted for safety].
Antigen testing including influenza antigen (IFV HA) and a test antigen (GFP) to measure anti-CBM and antiviral or test antigen antibodies [procedural detail omitted for safety].
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