Chimeric Vaccine For Haemophilus Influenzae-induced Disease

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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Organization International Bureau (43) International Publication Date 18 January 2007 (18.01.2007)
(51) International Patent Classification: C07K 14/195 (2006.01) (21) International Application Number: PCT/US2006/026183 (22) International Filing Date: (25) Filing Language: (26) Publication Language: (30) Priority Data: 60/697,642 60/801,835

PCT

(10) International Publication Number

W O 2007/008527 A3
(81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).

5 July 2006 (05.07.2006) English English

8 July 2005 (08.07.2005)
19 May 2006 (19.05.2006)

US US

(71) Applicant (for all designated States except US): CHIL¬ DREN'S HOSPITAL INC. [US/US]; 700 Children's Drive, Columbus, OH 43205 (US). (72) Inventors; and (75) Inventors/Applicants (for US only): BAKALETZ, Lau¬ ren, O . [US/US]; 4825 Canterwood Court, Hilliard, OH 43026 (US). MUNSON, Robert, S., Jr. [US/US]; 4825 Canterwood Court, Hilliard, OH 43026 (US). (74) Agent: SINTICH, Sharon, M.; MARSHALL, GERSTEIN & BORUN, 233 S . Wacker Drive, Suite 6300, Sears Tower, Chicago, IL 60606-6357 (US).

Published: — with international search report
(88) Date of publication of the international search report: 15 March 2007
For two-letter codes and other abbreviations, refer to the "G u id ance Notes o n Codes and Abbreviations" appearing at the b e g in ning of each regular issue of the PCT Gazette.

(54) Title: CHIMERIC VACCINE FOR HAEMOPHILUS INFLUENZAE-INDUCED DISEASE (57) Abstract: The invention described herein relates to a chimeric protein comprising the NTHi twitching pilus major subunit protein (PiIA) presenting a portion of the NTHi OMP P 5 protein. The invention provides for vaccine compositions comprising the recombinant chimeric protein and methods of eliciting an immune response using the recombinant chimeric proteins of the invention.

A . CLASSIFICATION O F SUBJECT MATTER

INV.

C07K14/195

According to International Patent Classification
B . FIELDS SEARCHED

(IPC) o r to both national classification and IPC

Minimum documentation searched

(classification system followed by classification symbols)

C07K

Documentation searched other than minimum documentation

t o the extent that such documents are included

i n the fields searched

Electronic data base consulted during the international search (name o f data base and, where practical, search terms used)

EPO-Internal

, Sequence Search , BIOSIS,

WPI Data

C. DOCUMENTS CONSIDERED T O B E RELEVANT
Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant t o claim No.

U S 5 843 464 A (BAKALETZ LAUREN 0 [US] ET AL) 1 December 1998 (1998-12-01) Abstract and claims. BAKALETZ L 0 ET AL: "DEMONSTRATION O F TYPE IV PILUS EXPRESSION AND A TWITCHING PHENOTYPE BY HAEMOPHILUS INFLUENZAE" INFECTION AND IMMUNITY, AMERICAN SOCIETY FOR MICROBIOLOGY. WASHINGTON, US, vol. 73, no. 3 , March 2005 (2005-03), pages 1635-1643, XP009048497 ISSN: 0019-9567 -/-

1-13

Further documents are listed i n the continuation o f Box C . * Special categories o f cited documents : "A" document defining the general state o f the art which i s not considered t o b e o f particular relevance "E" earlier document but published o n o r after the international filing date "L" document which may throw doubts o n priority claim(s) o r which is cited to establish the publication date o f another citation o r other special reason (as specified) "O" document referring t o a n oral disclosure, use, exhibition o r other means "P" document published prior to the international later than the priority date claimed filing date but

See patent family annex.

"T" later document published after the international filing date o r priority date and not i n conflict with the application but cited t o understand the principle o r theory underlying the invention "X" document o f particular relevance; the claimed invention cannot b e considered novel o r cannot b e considered t o involve a n inventive step when the document is taken alone "Y" document o f particular relevance; the claimed invention cannot b e considered t o involve a n inventive step when the document is combined with one o r more other such docu¬ ments, such combination being obvious t o a person skilled in the art. "&" document member o f the same patent family Date o f mailing of the international search report

Date o f the actual completion o f the international search

5 December 2006
Name and mailing address of the ISA/ European Patent Office, P.B. 5818 Patentlaan 2 NL - 2280 HV Rijswijk TeI. (+31-70) 340-2040, Tx. 3 1 651 epo nl, Fax: (+31-70) 340-3016

27/12/2006
Authorized officer

Simm, Mari o l a

6183
C(Continuation). DOCUMENTS CONSIDERED T O B E RELEVANT

Category*

Citation o f document, with indication, where appropriate, o t the relevant passages

Relevant to claim No.

& DATABASE UniProt [Online] 2 9 March 2005 (2005-03-29), "PiIA, Haemophilus influenzae" retrieved from UNIPROT accession no. Q5D8E3 Database accession no. Q5D8E3_HAEIN abstract
A

BAKALETZ L 0 ET AL: "Relative immunogenicity and efficacy of two synthetic chimeric peptides of fimbrin a s vaccinogens against nasopharyngeal colonization by nontypeable Haemophilus influenzae in the chinchilla" VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 15, no. 9 , June 1997 (1997-06), pages 955-961, XP004115360 ISSN: 0264-410X Discussion, page 959 and 960
WO 2005/063802 A 2 (CHILDRENS HOSPITAL INC [US]; BAKALETZ LAUREN 0 [US]; MUNSON ROBERT S J ) 14 July 2005 (2005-07-14) & DATABASE EPO Proteins [Online] 2 0 July 2005 (2005-07-20), "Sequence 2 from Patent W02005063802." retrieved from EBI accession no. EP0P:CS126771 Database accession no. CS126771

1-13

P ,A

A

POOLMAN J T ET AL: "Developing a nontypeable Haemophilus influenzae (NTHi) vaccine" VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 19, 8 December 2000 (2000-12-08), pages S108-S115, XP004227958 ISSN: 0264-410X CLEMANS DANIEL L ET AL: "Comparative analysis of Haemophilus influenzae hifA (Pilin) genes" INFECTION AND IMMUNITY, vol. 66, no. 2 , February 1998 (1998-02), pages 656-663, XP002410213 ISSN: 0019-9567
W O 99/64067 A 2 (SMITHKLINE BEECHAM BIOLOG [BE]; UNIV OHIO STATE RES FOUND [US]; BAKALE) 16 December 1999 (1999-12-16) The whole document specially page 7 : Peptides of the invention and claims.

A

A

1-13

INTERNATIONAL SEARCH REPORT
Box Il Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)

This International Search Report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:

1. | χ

Claims Nos.: because they relate to subject matter not required to be searched by this Authority, namely:

Although claims 10-13 are directed t o a method o f treatment of the human/animal body, the search has been carried out and based on the alleged effects of the compound/composition.
2.

Claims Nos.: because they relate to parts of the International Application that do not comply with the prescribed requirements to such a n extent that no meaningful International Search can be carried out, specifically:

3. I

I Claims Nos.: because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).

Box III Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
This International Searching Authority found multiple inventions in this international application, as follows:

1.

A s all required additional search fees were timely paid by the applicant, this International Search Report covers all searchable claims.

2.

A s all searchable claims could b e searched without effort justifying an additional fee, this Authority did not invite payment of any additional fee.

3.

As only some of the required additional search fees were timely paid by the applicant, this International Search Report covers only those claims for which fees were paid, specifically claims Nos.:

4.

No required additional search fees were timely paid by the applicant. Consequently, this International Search Report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.:

Remark on Protest

The additional search fees were accompanied by the applicant's protest.
No protest accompanied the payment o f additional search fees.

Patent document cited in search report

Publication date

Patent family member(s)

Publication date

U S 5843464

A

01-12-1998 14-07-2005

US

6436405 B l 2004309399 A l 2550455 A l 1697403 A 2 761293 4102199 9910973 2330238 1306437 1083926 2002517218 20006191 508616 362988 2006257418 200007255
B2

20-08-2002 14-07-2005 14-07-2005 06-09-2006 29-05-2003 30-12-1999 18-09-2001 16-12-1999 01-08-2001 21-03-2001 29-12-2003 18-06-2002 07-02-2001 26-09-2003 15-11-2004 16-11-2006 07-02-2002

WO 2005063802

AU CA
EP

W O 9964067

C A2 M

16-12-1999

AU AU
BR CA CN
EP

A A
Al

A
Al

HU JP NO NZ
PL US

0302965. A 2

T A
A
Al Al

ZA

A



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