US2013156803A1PendingUtilityA1

Compositions and methods related to p6

Assignee: PICHICHERO MICHAELPriority: Jun 4, 2011Filed: Jun 4, 2012Published: Jun 20, 2013
Est. expiryJun 4, 2031(~4.8 yrs left)· nominal 20-yr term from priority
A61K 2039/57A61K 39/102G01N 33/6854
37
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Claims

Abstract

Disclosed are compositions and methods related to vaccination for AOM and children prone to AOM.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . An epitope for an immunization against Nontypeable  Haemophilus influenzae  (NTHi), selected from the group of peptides of 3B9, 7F3 and 4G4, or mixtures thereof. 
     
     
         2 . The epitope of  claim 1 , reactive with anti-P6 polyclonal antibodies. 
     
     
         3 . The epitopes of  claim 2 , in combination with a pharmaceutical carrier for administration to a subject. 
     
     
         4 . The epitopes of  claim 3 , in an effective concentration for administration to a subject to neutralize Nontypeable  Haemophilus influenzae  (NTHi). 
     
     
         5 . The epitopes of  claim 1 , further comprising a pharmaceutical carrier for administration to a patient, wherein the carrier and concentration of sequences elicit an immune response when administered to a subject. 
     
     
         6 . The epitopes of  claim 1  labeled with a compound selected from the group consisting of dyes, fluorescent labels, chemiluminescent labels, enzymes, and radioactive labels. 
     
     
         7 . The epitopes of  claim 1  immobilized onto a substrate. 
     
     
         8 . A method for screening patients for Nontypeable  Haemophilus influenzae  (NTHi) infection comprising reacting a biological sample with the epitopes of  claim 1 . 
     
     
         9 . The method of  claim 8  wherein the epitopes are labeled with a compound selected from the group consisting of dyes, fluorescent labels, chemiluminescent labels, enzymes, and radioactive labels. 
     
     
         10 . The method of  claim 8  wherein the epitopes are immobilized onto a substrate. 
     
     
         11 . The method of  claim 10 , further comprising predicting the prognosis of the patient based on the reactivity of the patient sample with the epitopes. 
     
     
         12 . A method for treating patients for Nontypeable  Haemophilus influenzae  (NTHi) comprising administering to the patient an epitope of  claim 1 , or mixtures thereof, in an amount effective to inhibit a Nontypeable  Haemophilus influenzae  (NTHi) infection. 
     
     
         13 . The method of  claim 12  wherein the epitope acts as a vaccine against Nontypeable  Haemophilus influenzae  (NTHi) infection. 
     
     
         14 . The method of  claim 13 , wherein the subject has an Nontypeable  Haemophilus influenzae  (NTHi) ear infection. 
     
     
         15 . The method of  claim 12 , wherein the subject is prone to ear infections. 
     
     
         16 . A vaccine for inhibiting infection comprising the epitope of  claim 1 , in combination with an antigenic pharmaceutical carrier. 
     
     
         17 . A method for vaccinating a host against a Nontypeable  Haemophilus influenzae  (NTHi) infection comprising providing the epitope of  claim 1  in combination with an antigenic pharmaceutical carrier. 
     
     
         18 . The epitope of  claim 1 , wherein the epitope is at a concentration of at least 1.1, 1.2, 1.3, 1.5, 1.7, 1.9, 2.0, 2.5, 3.0, 5, 7, or 10 fold the P6 and P6 epitope of a vaccine having P6, protein D, and OMP24 present in them. 
     
     
         19 . A vaccine comprising the epitope of  claim 18 . 
     
     
         20 . The vaccine of  claim 19 , further comprising P6 at a concentration of at least 1.1, 1.2, 1.3, 1.5, 1.7, 1.9, 2.0, 2.5, 3.0, 5, 7, or 10 fold the P6 and P6 epitope of a vaccine having P6, protein D, and OMP24 present in them. 
     
     
         21 . A vaccine comprising P6 at a concentration of at least 1.1, 1.2, 1.3, 1.5, 1.7, 1.9, 2.0, 2.5, 3.0, 5, 7, or 10 fold the P6 and P6 epitope of a vaccine having P6, protein D, and OMP24 present in them. 
     
     
         22 . A vaccine further comprising the epitope of  claim 18 . 
     
     
         23 . A vaccine comprising P6, or an epitope of  claim 1 , or mixture there of, wherein the vaccine comprises a concentration of antigen greater than 1.1, 1.2, 1.3, 1.5, 1.7, 1.9, 2.0, 2.5, 3.0, 5, 7, or 10 fold the P6 and P6 epitope antigen of a vaccine having P6, protein D, and OMP24 present in them. 
     
     
         24 . The vaccine as claimed in  claim 8 , wherein the vaccine is in a capsular form. 
     
     
         25 . A method of vaccination, said method comprising step of administering therapeutically effective dose of the vaccine of  claim 23  to a subject in need thereof. 
     
     
         26 . The method of  claim 25 , wherein the subject has Nontypeable  Haemophilus influenzae  (NTHi). 
     
     
         27 . The method of  claim 25 , wherein the subject is prone to have Nontypeable  Haemophilus influenzae  (NTHi). 
     
     
         28 . The method of  claim 25 , wherein the vaccine is administered through an oral route or intra peritoneal route. 
     
     
         29 . The method of  claim 25 , wherein the vaccine is administered in capsular form. 
     
     
         30 . The method of  claim 25 , wherein the vaccine is administered at a dosage ranging from 0.01 mg/ml/kg to 100 mg/ml/kg. 
     
     
         31 . The method of  claim 25 , wherein the vaccine is capable of inhibiting an Nontypeable  Haemophilus influenzae  (NTHi) infection in a subject prone to Nontypeable  Haemophilus influenzae  (NTHi), to a greater extent than a vaccine comprising Protein D or OMP26. 
     
     
         32 . A kit for vaccination, said kit comprising a vaccine of  claim 22  in a deliverable form. 
     
     
         33 . A vaccine comprising P6 and Protein D, epitopes of P6 or Protein D, or mixtures thereof, but not OMP26 of non typeable  Haemophilus influenzae  (NTHi). 
     
     
         34 . The vaccine of  claim 33 , wherein the vaccine consists of P6 or P6 epitopes. 
     
     
         35 . A method of treating a child, comprising identifying a child wherein the child is prone to having acute otitis media (AOM) and administering the vaccine of  claim 34  to the child.

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