WO1997040165B1 - Novel human cytomegalovirus dna constructs and uses therefor - Google Patents

Novel human cytomegalovirus dna constructs and uses therefor

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Publication number
WO1997040165B1
WO1997040165B1 PCT/US1997/006866 US9706866W WO9740165B1 WO 1997040165 B1 WO1997040165 B1 WO 1997040165B1 US 9706866 W US9706866 W US 9706866W WO 9740165 B1 WO9740165 B1 WO 9740165B1
Authority
WO
WIPO (PCT)
Prior art keywords
immunogenic composition
pδrc
group
hcmv
human cytomegalovirus
Prior art date
Application number
PCT/US1997/006866
Other languages
French (fr)
Other versions
WO1997040165A1 (en
WO1997040165A9 (en
Filing date
Publication date
Application filed filed Critical
Priority to AU28098/97A priority Critical patent/AU2809897A/en
Priority to US09/171,699 priority patent/US6448389B1/en
Priority to EP97922429A priority patent/EP0914441A2/en
Publication of WO1997040165A1 publication Critical patent/WO1997040165A1/en
Publication of WO1997040165B1 publication Critical patent/WO1997040165B1/en
Publication of WO1997040165A9 publication Critical patent/WO1997040165A9/en

Links

Abstract

Novel DNA molecules for in vitro and in vivo expression of HCMV gB, gB transmembrane-deleted derivatives, pp65, pp150, and IE-exon-4 proteins are described. Preferably, the molecules are plasmids. Also described are methods of using these DNA molecules to induce immune responses to HCMV, and the use of a plasmid of the invention to prime immune responses to HCMV vaccines.

Claims

AMENDED CLAIMS
[received by the International Bureau on 25 November 1997 (25.11.97); original claims 13-28 replaced by new claims 13-32; remaining claims unchanged (4 pages)]
13. A pCBgBΔtm plasmid, said plasmid comprising the human cytomegalovirus (HCMV) gB gene containing a deletion in the transmembrane domain.
14. An immunogenic composition comprising a carrier and a DNA molecule according to any of claims 1-5.
15. The immunogenic composition according to claim 14 wherein the DNA molecule is selected from the group consisting of:
(a) pΔRC-gB;
(b) pTet-gB;
(c) pΔRC-pp65;
(d) pΔRC-gE ;
(e) pΔRC-ppl50;
(f) pCBgB;
(g) pCBgBΔtm; and (h) pΔRC-exon-4.
16. The immunogenic composition according to claim 14 or 15 comprising two or more DNA molecules.
17. The immunogenic composition according to claim 15 comprising a first DNA molecule which comprises a sequence encoding the gB antigen or a gB derivative, and a second DNA molecule which comprises a sequence encoding the pp65 antigen.
18. The immunogenic composition according to any of claims 13 to 17 wherein the carrier is selected from the group consisting of saline and isotonic water.
44
19. A method of inducing human cytomegalovirus-specific (HCMV) immune responses in an animal, comprising the step of administering to said animal an effective amount of a first immunogenic composition according to any of claims 14 to 18.
20. The method according to claim 19 wherein the composition comprises pTet-gB and pΔRC-pp65.
21. The method according to claim 19 further comprising the step of administering a second immunogenic composition to said animal, said second immunogenic composition comprising a plasmid selected from the group consisting of:
(a) pΔRC-gB;
(b) pTet-gB;
(c) pΔRC-pρ65;
(d) pΔRC-gE ;
(e) pΔRC-ppl 50;
(f) pCBgB;
(g) pCBgBΔtm; and (h) pΔRC-IE-Exon-4.
22. The method according to claim 19, wherein said second immunogenic composition is administered between about 2 to about 15 weeks following administration of said first immunogenic composition.
23. The use of a DNA molecule according to any of claims 1 to 5 or a plasmid according to any of claims 6 to 13 in the preparation of a medicament to treat a cytomegalovirus infection.
45
24. A method of priming immune responses to a selected human cytomegalovirus immunogenic composition, comprising the steps of: administering a first immunogenic composition according to any of claims 14 to 18 and administering the selected human cytomegalovirus immunogenic composition.
25. The method according to claim 24 wherein the first immunogenic composition is administered between about 4 and 15 weeks prior to administration of the selected immunogenic composition.
26. The method according to claim 24 or claim 25 wherein the first immunogenic composition comprises pTet-gB.
27. The method according to claim 26, wherein pTet-gB is administered in an amount between about 50 μg to about 160 μg.
28. The method according to claim 24, wherein the selected immunogenic composition comprises an immunogen selected from the group consisting of a recombinant virus comprising an HCMV immunogen, an HCMV protein, and HCMV virions.
29. The method according to claim 28 wherein the HCMV protein is gB.
30. The method according to claim 28 wherein the recombinant virus is selected from the group consisting of Ad5.gb and Ad5-lE-exon-4.
46
31. A DNA molecule which is non-replicating in mammals and comprises a sequence encoding a human cytomegalovirus antigen selected from the group consisting of:
(a) pp65; (b) pP150;
(c) immediate-early exon-4;
(d) gB and an antigen of (a) to (c);
(e) a gB derivative lacking at least the transmembrane domain and an antigen of (a) to (c); and
(f) a combination of antigens (a) to (c).
32. An immunogenic composition comprising a carrier and at least two DNA molecules, wherein said DNA molecules are selected from the group consisting of:
(a) gB;
(b) a gB derivative lacking at least the transmembrane domain;
(c) pp65; (d) ρpl50; and
(e) immediate-early exon-4.
STATEMENT UNDER ARTICLE 19
Following entry of the attached replacement pages, claims 1 - 32 are pending.
The claims have been amended to recite two plasmid constructs disclosed throughout the application, but not previously claimed. See, new claims 12 and 13, amended claims 15 and 21. Particularly, pCBgB and pCBgBΔtm are supported in Example 14, page 34, line 1 through page 37, line 10 of the specification as filed. No new matter is added by this amendment. Inclusion of these two claims requires addition of two additional inventors, as requested in the attached letter.
In addition, two new independent claims have been added, which are supported by original claims 1 and 12, but are of narrower scope. These claims are believed to overcome the prior art cited in the International Search Report.
48
PCT/US1997/006866 1996-04-23 1997-04-22 Novel human cytomegalovirus dna constructs and uses therefor WO1997040165A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU28098/97A AU2809897A (en) 1996-04-23 1997-04-22 Novel human cytomegalovirus dna constructs and uses therefor
US09/171,699 US6448389B1 (en) 1996-04-23 1997-04-22 Human cytomegalovirus DNA constructs and uses therefor
EP97922429A EP0914441A2 (en) 1996-04-23 1997-04-22 Novel human cytomegalovirus dna constructs and uses therefor

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1571796P 1996-04-23 1996-04-23
US60/015,717 1996-04-23

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US09/171,699 A-371-Of-International US6448389B1 (en) 1996-04-23 1997-04-22 Human cytomegalovirus DNA constructs and uses therefor
US10/223,538 Division US20030120060A1 (en) 1996-04-23 2002-08-19 Human cytomegalovirus DNA constructs and uses therefor

Publications (3)

Publication Number Publication Date
WO1997040165A1 WO1997040165A1 (en) 1997-10-30
WO1997040165B1 true WO1997040165B1 (en) 1998-01-08
WO1997040165A9 WO1997040165A9 (en) 1998-02-12

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US (2) US6448389B1 (en)
EP (1) EP0914441A2 (en)
AU (1) AU2809897A (en)
WO (1) WO1997040165A1 (en)

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