Omp p6 vaccine for treating and preventing chlamydia infection

Abstract

The present invention provides a vaccine for immunization of a host, including humans, against disease caused by infection by a strain of Chlamydia , specifically C. pneumoniae . The vaccine contains a polypeptide comprising an omp P6 precursor sequence of a strain of C. pneumoniae and variants of the sequence. Modifications are possible within the scope of this invention.

1 . A method for preventing or treating  Chlamydia  infection comprising the step of administering a composition comprising a protein and an adjuvant, wherein the protein comprises the amino acid sequence set forth in SEQ ID No:2. 
     
     
         2 . The method according to  claim 1  wherein the protein is a fusion protein comprising the amino acid sequence fused with a heterologous polypeptide. 
     
     
         3 . The method according to  claim 2  wherein the heterologous polypeptide is a peptide tail for purifying the protein. 
     
     
         4 . The method according to  claim 1  wherein the adjuvant is a liposome. 
     
     
         5 . The method according to  claim 4  wherein the liposome is at least one liposome selected from the group consisting of neutral liposomes, anionic liposomes, microspheres, ISCOMS, and virus-like-particles (VLPs). 
     
     
         6 . The method according to  claim 1  wherein the composition is administered parenterally. 
     
     
         7 . The method according to  claim 6  wherein the adjuvant is at least one adjuvant selected from the group consisting of an aluminum compound, RIBI, polyphosphazene, DC-chol (3 b-(N—(N′,N′-dimethyl aminomethane)-carbamoyl) cholesterol) and QS-21. 
     
     
         8 . The method according to  claim 7  wherein the adjuvant is aluminum hydroxide, aluminum phosphate, or aluminum hydroxy phosphate. 
     
     
         9 . The method according to  claim 1  wherein the composition is administered mucosally. 
     
     
         10 . The method according to  claim 9  wherein the adjuvant is at least one adjuvant selected from the group consisting of bacterial toxin, bacterial monophosphoryl lipid A (MPLA), saponin, polylactide glycolide (PLGA) microsphere, polyphosphazene, DC-chol (3 b-(N—(N′,N′-dimethyl aminomethane)-carbamoyl) cholesterol), and QS-21. 
     
     
         11 . The method according to  claim 10  wherein the adjuvant is at least one bacterial toxin selected from the group consisting of cholera toxin (CT),  E. coli  heat-labile toxin (LT),  Clostridium difficile  toxin A, pertussis toxin (PT), and combinations, subunits, toxoids, or mutants thereof that retain adjuvant activity and/or have reduced toxicity. 
     
     
         12 . The method according to  claim 11  wherein the adjuvant is at least one bacterial toxin selected from the group consisting of native cholera toxin subunit B (CTB), Arg-7-Lys CT mutant, Arg-192-Gly LT mutant, Arg-9-Lys PT mutant, Glu-129-Gly PT mutant, Ser-63-Lys LT mutant, Ala-69-Gly LT mutant, Glu-110-Asp LT mutant, and Glu-112-Asp LT mutant. 
     
     
         13 . The method according to  claim 10  wherein the adjuvant is bacterial monophosphoryl lipid A (MPLA) of  E. coli, Salmonella minnesota, Salmonella typhimurium , or  Shigella flexneri.    
     
     
         14 . The method according to  claim 1  wherein the composition is in unit dosage form. 
     
     
         15 . The method according to  claim 1  wherein the composition is administered as a priming dose and a booster dose. 
     
     
         16 . The method according to  claim 1  wherein the composition is administered as a booster dose in conjunction with a vaccine vector encoding and expressing the amino acid sequence set forth in SEQ ID NO:2. 
     
     
         17 . The method according to  claim 1  wherein the composition is administered at less than 1 mg per dose. 
     
     
         18 . The method according to  claim 1  wherein the composition is administered at 100 μg per dose. 
     
     
         19 . The method according to  claim 1  wherein the composition is administered at 10 μg to 500 mg per dose. 
     
     
         20 . The method according to  claim 1  wherein the composition is administered at 1 mg to 200 mg per dose. 
     
     
         21 . The method according to  claim 16  wherein the composition is administered as a booster dose mucosally at 10 μg to 500 mg per dose. 
     
     
         22 . The method according to  claim 16  wherein the composition is administered as a booster dose mucosally at 1 mg to 200 mg per dose.