Vaccine for the prevention of breast cancer relapse

Abstract

The invention features methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, E75, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as recombinant human GM-CSF, and the E75 peptide at an optimized dose and schedule. The methods further comprise administering an annual or semi-annual booster vaccine dose due to declining E75-specific T cell immunity. The invention also features vaccine compositions for use in the methods.

1 - 34 . (canceled) 
     
     
         35 . A method of inducing protective or therapeutic immunity against a HER2/neu expressing tumor with a fluorescence in situ hybridization (FISH) rating of greater than about 0 to less than about 2.0 for HER2/neu gene expression in a subject, the method comprising administering to the subject an effective amount of a composition comprising a pharmaceutically effective carrier, and a peptide having the amino acid sequence SEQ ID NO:2. 
     
     
         36 . The method of  claim 35 , wherein the composition is formulated as a liquid. 
     
     
         37 . The method of  claim 36 , wherein the liquid is a solution, suspension, or emulsion. 
     
     
         38 . The method of  claim 35 , wherein the composition is formulated as a freeze-dried preparation and converted to a liquid formulation prior to administration. 
     
     
         39 . The method of  claim 36 , wherein the liquid comprises an organic or inorganic solvent. 
     
     
         40 . The method of  claim 37 , wherein the liquid is water, alcohol, saline, dextrose solution or propylene glycol solution. 
     
     
         41 . The method of  claim 35 , wherein the composition is formulated in the form of a pharmaceutically acceptable salt. 
     
     
         42 . The method of  claim 41 , wherein the pharmaceutically acceptable salt is an acid addition salt formed with a free amino group of the peptide and an organic or inorganic acid. 
     
     
         43 . The method of  claim 41 , wherein the salt is formed with a free carboxyl group of the peptide and an inorganic or organic base. 
     
     
         44 . The method of  claim 35 , wherein the composition is administered intravenously, intramuscularly, intracutaneously, subcutaneously, intrathecally, intraduodenally, intraperitoneally, intranasally, vaginally, orally, or transdermally. 
     
     
         45 . The method of  claim 35 , further comprising administering to the subject a booster composition comprising an effective amount of a pharmaceutically effective carrier and a peptide having the amino acid sequence SEQ ID NO:2. 
     
     
         46 . The method of  claim 45 , wherein the booster composition is formulated as a liquid. 
     
     
         47 . The method of  claim 46 , wherein the liquid is a solution, suspension, or emulsion. 
     
     
         48 . The method of  claim 45 , wherein the booster composition is formulated as a freeze-dried preparation and converted to a liquid formulation prior to administration. 
     
     
         49 . The method of  claim 45 , wherein the booster composition is administered intravenously, intramuscularly, intracutaneously, subcutaneously, intrathecally, intraduodenally, intraperitoneally, intranasally, vaginally, orally, or transdermally.