초록

The invention provides anti-idiotypic HCMV antibodies as well as methods of using the same.

대표청구항 ▼

1. An isolated monoclonal anti-idiotypic antibody that specifically binds to an anti-human cytomegalovirus (HCMV) antibody, wherein the anti-HCMV antibody comprises the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2, wherein the isolated monoclonal anti-idiotypic a

1. An isolated monoclonal anti-idiotypic antibody that specifically binds to an anti-human cytomegalovirus (HCMV) antibody, wherein the anti-HCMV antibody comprises the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2, wherein the isolated monoclonal anti-idiotypic antibody is conjugated to a heterologous moiety or detectable moiety. 2. The isolated monoclonal anti-idiotypic antibody of claim 1, wherein the isolated monoclonal anti-idiotypic antibody comprises three heavy chain hypervariable regions (HVR-H1, HVR-H2 and HVR-H3) and three light chain hypervariable regions (HVR-L1, HVR-L2 and HVR-L3), wherein: (a) HVR-H1 comprises the amino acid sequence of SEQ ID NO: 13;(b) HVR-H2 comprises the amino acid sequence of SEQ ID NO: 14;(c) HVR-H3 comprises the amino acid sequence of SEQ ID NO: 15;(d) HVR-L1 comprises the amino acid sequence of SEQ ID NO: 16;(e) HVR-L2 comprises the amino acid sequence of SEQ ID NO: 17; and(f) HVR-L3 comprises the amino acid sequence of SEQ ID NO: 18. 3. The isolated monoclonal anti-idiotypic antibody of claim 1, wherein the anti-idiotypic antibody comprises the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 7. 4. The isolated monoclonal anti-idiotypic antibody of claim 1, wherein the anti-idiotypic antibody specifically binds to at least one HVR of an anti-HCMV antibody comprising the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2. 5. The isolated monoclonal anti-idiotypic antibody of claim 1, wherein the detectable moiety is a detectable label or biotin. 6. An enzyme-linked immunosorbent assay (ELISA) method for specifically detecting in a biological sample the anti-human cytomegalovirus (HCMV) antibody comprising the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2: comprising (a) contacting and incubating the biological sample with a capture reagent, wherein the capture reagent is the anti-idiotypic antibody of claim 1, so as to bind the anti-HCMV antibody present in the sample, thereby forming an immunocomplex; and(b) contacting the immunocomplex from (a) with a detectable antibody that binds to the anti-HCMV antibody, and measuring the level of the anti-HCMV antibody bound to the anti-idiotypic antibody using a detection means for the detectable antibody. 7. The method of claim 6, wherein the capture reagent is immobilized to a solid support and the method further comprises the step of separating the biological sample from the immobilized capture reagent bound to the anti-HCMV antibody. 8. The method of claim 7, wherein the immobilized capture reagent is conjugated to biotin and bound to a streptavidin coated microtiter plate. 9. The method of claim 6, wherein the detectable antibody is an antibody from a non-human species that binds to human antibodies. 10. The method of claim 9, wherein the detectable antibody is directly detectable, or is conjugated to horseradish peroxidase, or is detected by a fluorometric or calorimetric reagent. 11. The method of claim 6, wherein the isolated monoclonal anti-idiotypic antibody comprises the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 7. 12. The method of claim 6, wherein the isolated monoclonal anti-idiotypic antibody comprises three heavy chain hypervariable regions (HVR-H1, HVR-H2 and HVR-H3) and three light chain hypervariable regions (HVR-L1, HVR-L2 and HVR-L3), wherein: (a) HVR-H1 comprises the amino acid sequence of SEQ ID NO: 13;(b) HVR-H2 comprises the amino acid sequence of SEQ ID NO: 14;(c) HVR-H3 comprises the amino acid sequence of SEQ ID NO: 15;(d) HVR-L1 comprises the amino acid sequence of SEQ ID NO: 16;(e) HVR-L2 comprises the amino acid sequence of SEQ ID NO: 17; and(f) HVR-L3 comprises the amino acid sequence of SEQ ID NO: 18. 13. The method of claim 12, wherein the isolated monoclonal anti-idiotypic antibody comprises the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 7. 14. The method of claim 6, wherein the biological sample is isolated from a human subject. 15. The method of claim 14, wherein the human subject has been treated with the anti-HCMV antibody comprising the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2. 16. The method of claim 6, wherein the method further comprises using a standard curve to determine the level of the anti-HCMV antibody compared to a known level of the anti-HCMV antibody. 17. The method of claim 6, wherein the biological sample is blood, plasma or serum. 18. An immunoassay kit for specifically detecting in a biological sample the isolated monoclonal anti-human cytomegalovirus (HCMV) antibody comprising the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2; the kit comprising: (a) a container containing, as a capture reagent, at least one isolated monoclonal anti-idiotypic antibody that specifically binds to the antibody of interest; (b) a container containing a detectable antibody that binds to the antibody of interest; and (c) instructions for detecting said antibody of interest; wherein the at least one isolated monoclonal anti-idiotypic antibody is conjugated to a heterologous moiety or detectable moiety. 19. The kit of claim 18, wherein the kit is useful in an ELISA method for detecting the antibody of interest. 20. The kit of claim 18, wherein the isolated monoclonal anti-idiotypic antibody is the isolated monoclonal anti-idiotypic antibody comprising the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 7. 21. The kit of claim 18, wherein the isolated monoclonal anti-idiotypic antibody comprises three heavy chain hypervariable regions (HVR-H1, HVR-H2 and HVR-H3) and three light chain hypervariable regions (HVR-L1, HVR-L2 and HVR-L3), wherein: (a) HVR-H1 comprises the amino acid sequence of SEQ ID NO: 13;(b) HVR-H2 comprises the amino acid sequence of SEQ ID NO: 14;(c) HVR-H3 comprises the amino acid sequence of SEQ ID NO: 15;(d) HVR-L1 comprises the amino acid sequence of SEQ ID NO: 16;(e) HVR-L2 comprises the amino acid sequence of SEQ ID NO: 17; and(f) HVR-L3 comprises the amino acid sequence of SEQ ID NO: 18.