Hepatitis B pre-S2 nucleic acid

• US 8,138,318 B2
• Filed: 09/11/2008
• Issued: 03/20/2012
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Coleman, Paul F., Pearce, Sandra K.
• Primary Examiner(s): LI, BAO Q
• Application Number:
  US12/209,093
• Publication Number:
  US 20090104712A1
• Time in Patent Office: 1,286 Days
• Field of Search: None
• US Class Current: 536/23.1
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C12N 2730/10122 New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes

Abstract

This invention relates to a nucleic acid molecule encoding a middle Hepatitis B virus (HBV) surface protein, a vector comprising the nucleic acid molecule, a host cell comprising the vector, and a composition comprising the expression products of this vector, which may comprise middle HBV surface protein, or a mixture of middle HBV surface protein and small HBV surface protein. The compositions of the invention may be useful for expressing a middle HBV surface protein, or a mixture of small and middle HBV surface proteins in defined ratios, determining the binding of an antibody to a middle or small HBV surface protein, determining the quality of an anti-middle or an anti-small HBV surface protein antibody, or determining the quality of a kit containing anti-middle or anti-small HBV surface protein antibodies.

Claims

1. An isolated nucleic acid molecule encoding a middle Hepatitis B virus surface protein (MHB), wherein the nucleotide sequence of said molecule comprises a preS2 initiation sequence, wherein said preS2 initiation sequence starts with AAG or GAG nucleic acid sequence from the 5′

end and before the initiation codon ATG of the preS2.

2. The nucleic acid molecule of claim 1, wherein the nucleotide sequence of the nucleic acid molecule comprises SEQ ID NO:

7.

3. The nucleic acid molecule of claim 1, wherein the nucleotide sequence of the nucleic acid molecule comprises SEQ ID NO:

8.

4. The isolated nucleic acid molecule of claim 1, wherein the nucleic acid molecule further comprises a nucleotide sequence encoding a small Hepatitis B virus surface protein (SHB).

5. A vector comprising the nucleic acid molecule of claim 1.

6. An isolated host cell comprising the vector of claim 5.

11. A kit comprising the vector of claim 5.

12. A kit comprising the host cell of claim 6.

7. A composition comprising isolated, recombinant MHB at a concentration of 1×

10<sup>−

12</sup> to 1×

10<sup>−

2</sup> gms.

8. The composition of claim 7, wherein the composition further comprises isolated, recombinant SHB.

9. The composition of claim 8, wherein the SHB is at a concentration of 1×

10¹² to 1×

10<sup>−

2</sup> gms.

10. The composition of claim 8, wherein the ratio of MHB to SHB is between 1:

1000 and 1000;

1.

13. A kit comprising the composition of claim 7.