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(12) Patent Application Publication (10) Pub. No.: US 2014/0193460 A1 Spector Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2014/0193460 A1 Spector Et Al US 20140193460A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0193460 A1 Spector et al. (43) Pub. Date: Jul. 10, 2014 (54) HERPES VIRUS VACCNE AND METHODS OF (60) Provisional application No. 61/503.945, filed on Jul. 1, USE 2011. (71) Applicant: The Regents of the University of California, Oakland, CA (US) Publication Classification (72) Inventors: Deborah H. Spector, La Jolla, CA (US); Christopher S. Morello, Carlsbad, CA (51) Int. Cl. (US); Kimberly A. Kraynyak, A639/245 (2006.01) Encinitas, CA (US) (52) U.S. Cl. CPC .................................... A61K 39/245 (2013.01) (73) Assignee: The Regents of the University of California, Oakland, CA (US) USPC ..................................... 424/231.1; 424/229.1 (21) Appl. No.: 14/141,251 (57) ABSTRACT (22) Filed: Dec. 26, 2013 Related U.S. Application Data Provided herein are, interalia, vaccines and methods of using (63) Continuation of application No. PCT/US2012/ the same for the treatment or prevention of Herpesvirus infec 045290, filed on Jul. 2, 2012. tions. Patent Application Publication Jul. 10, 2014 Sheet 1 of 30 US 2014/0193460 A1 Fig. 1B. gD2t 293 gC2t 293 2 5 7 2 2 5 7 2 Day 66 CeS. Meia Fig. 1C. MW gC2t (t) BSA (ng) S 200 eme Patent Application Publication Jul. 10, 2014 Sheet 2 of 30 US 2014/0193460 A1 Fig. 2A. Experiment 1 HSV-2 Survivors (n=8) pVAX 1 7 UL5 1 6 - Fig. 2B. s 3 H O ES55 Fig. 2C. O 1 2 3 4 5 6 7 Day Postchallenge Patent Application Publication Jul. 10, 2014 Sheet 3 of 30 US 2014/0193460 A1 Fig. 2D. Experiment 2 HSV-2 Survivors (n=8) Gene(s) - go2t +gD2t pVAX O 7 UL5 + UL30 1 7 Fig. 2E. s : 5 Fig. 2F. O 1 2 3 4 5 6 7 Day Postchallenge Patent Application Publication Jul. 10, 2014 Sheet 4 of 30 US 2014/0193460 A1 O.25 OOO CP27- CP27- CP27- CP27 Cells Peptide Cells Peptide Naive HSV-2 1 OO O.75 0.50 O.25 OOO CP27- CP27- CP27- CP27- Stimulation Cells Peptide Cells Peptide in vitro pVAX HSV-2 Immunization Patent Application Publication Jul. 10, 2014 Sheet 5 of 30 US 2014/0193460 A1 Fig. 3B. UL5 Cell Stimulation U 30 Ce Stimulation 2. O A 1 5 1 O O5 A A y OO pVAX 5 HSV-2 pVAX U3O HSV-2 Fig. 3C. UL5 Cell Stimulation UL30 Cell Stimulation on 1.5 d5 O r 1.0 --- 2. t 0.5 C () & O.0 pVAX U.5 UL5 pVAX U3O U.5 -- - UL30 U3O Immunization Patent Application Publication Jul. 10, 2014 Sheet 6 of 30 US 2014/0193460 A1 Fig. 4A. Survivors Waccine (n=8) F-MOCk O gD2t protein 5 F-HSV2 8 Fig. 4B. 4 a 3 3 f) Of : -- 2 () asi a 1 O-ace 8 O 4 8 12 16 Day Postchallenge Fig. 4C. 6 D 6 - 5 S 5 S. ... ? ;4 92s 4 o + 3 3 S 2 > 9 2 - stis - 1 O O C 2 3 4 5 S 7 Day Postchallenge Patent Application Publication Jul. 10, 2014 Sheet 7 of 30 US 2014/0193460 A1 Fig. 5A. F-HSW s DNA or g|D2t SU HSV89. as Shedding l R H Week 0 1 2 3 7 S 9 O 1 2 3 4 5 6 7 Yemaero-1 Survival Disease Scoring Fig. 5B. No. of Survivors (n=8) BOOSt + MPLAum F- gD2t F DNA Prime Mock Protein HSV2 pVAX O 8 7 gD2t DNA 5 8 8 UL5, UL30, gD2t DNAS 3 6* 7 n = 7 Patent Application Publication Jul. 10, 2014 Sheet 8 of 30 US 2014/0193460 A1 Fig. 5C. Vock Boost gD2t Protein Boost F-HSW2 Boost a0 pVAX - Fi-Mock pVAX - g2t Protein ms pVAX - F-HSV2 - A go2 DNA - FI-Mock ada gD2t DNA- g2t Protein gD2t DNA- F-HSV2 UL5, UL30, gD2t DNAs - - UL5, UL30, gD2t DNAS -- UL5, UL30, gD2t DNAs F-Wock gD2t Protein F-HSW2 4. 3 2 1 O 2 4 6 8 10 12 4.5 3 2 O 2 4 6 8 10 O Day Postchallenge Patent Application Publication Jul. 10, 2014 Sheet 9 of 30 US 2014/0193460 A1 Fig. 6A. Day 2 5 (--) (-) o - 4 t PEm 3 O , A A 8, 2 a A 2 A. O "AA" N Ns N e N e sš & X & ^ s Sy Fig. 6B s P2 ... -- ,w 2. Patent Application Publication Jul. 10, 2014 Sheet 10 of 30 US 2014/0193460 A1 Long-Term (rek) () (k) (e) 4. esses elemmer - T.I.----- E. mom m - Sease - E - E. -- - E. Er MNNE E. --- -e T - A. e. --- w q S. Fig. 6D. Long-Term s 24 (insi ris * + k} is kk: - to -- : . 2 w 2 to c , N is 9 c) 2. Patent Application Publication Jul. 10, 2014 Sheet 11 of 30 US 2014/0193460 A1 Fig. 7A. 5 Day 2 g' () ( ) (4) asS 4ola 3 A. y + St 2 v y S 1 ---...-----A Aa vy O ACP Ah Ah ACP AdP Ah Ah AdP im, S.C. i.m. i.m. im. S.C. i.m. i.m. pVAX FI-HSV2 pVAX FI-HSV2 F-MOCK F-MOCK Fig. 7B. 4 1 O Day Day 2 4. Patent Application Publication Jul. 10, 2014 Sheet 12 of 30 US 2014/0193460 A1 Fig. 7C CD F-HSV2 Ah S.C. F-HSV2 Ah in F-HSV2 AdP m. as C C G.CD 8 . y on 9 - () 1 Day 2 Postchallenge LogPFU (Indiv.) Patent Application Publication Jul. 10, 2014 Sheet 13 of 30 US 2014/0193460 A1 Fig. 8A. EDay 2 Day 4 6 {x} s (8) - H 5 3: (ns) (ns) ( . ) (rex) s (ns) (ns) (ert) (err) ar -- 2 o -- 4 --- m AA ?h-2 s Y . A d (t 3 I. A A O 5 AA 0. m 2 A. v - s 2 A. N- w t8 w A. w 1 V - w - - - - - - - - - - - - - -- a--a a re - A- - a- - - - - - - - -. 0- - - - - - |..................--------------- ---. AAA.- 0. 0 new 400 - S &S s S. s' s K s s g w &&Y &e xySw s g Š t 3? N « & S w: Sg S& (S Q s& S& w& S.{ S.s' (S N S& s'8 < & *3 * * s' 8 { & 3 & 8a Fig. 8B. 2 O 1 5 i 10 O ss S. s Patent Application Publication Jul. 10, 2014 Sheet 14 of 30 US 2014/0193460 A1 Fig. 8C. 1 O O O Patent Application Publication Jul. 10, 2014 Sheet 15 of 30 US 2014/0193460 A1 Fig. 9A. Patent Application Publication Jul. 10, 2014 Sheet 16 of 30 US 2014/0193460 A1 i s 8 :s d werS Sw sea Lik-N-800% % i ce or to r w is Patent Application Publication Jul. 10, 2014 Sheet 17 of 30 US 2014/0193460 A1 Patent Application Publication Jul. 10, 2014 Sheet 18 of 30 US 2014/0193460 A1 r CN O v (Nipu pueueeW) Je. Apod). UW 6uZellneN 1. 3 3. & 3. % SSS . 2 SSSSSS & O'S -f- ueeN (6o) uel Luodpu Patent Application Publication Jul. 10, 2014 Sheet 19 of 30 US 2014/0193460 A1 Patent Application Publication Jul. 10, 2014 Sheet 20 of 30 US 2014/0193460 A1 or co e ri (N. c. 1x tw s ce s e as c 2, c) hass C isa- Seo-N+80.3% o% 9 is 9 Y r C O CN o 2 C CAO C O s Sileo L+k-N-1 +vco % % Patent Application Publication Jul. 10, 2014 Sheet 21 of 30 US 2014/0193460 A1 Patent Application Publication Jul. 10, 2014 Sheet 22 of 30 US 2014/0193460 A1 i i e o XY wo (Apu + lueeW) elopS eSeeSC enow peuunS Patent Application Publication Jul. 10, 2014 Sheet 23 of 30 US 2014/0193460 A1 n wer a (Apu + ueeW) n-dfo to i r N ven to (Apu) + ueeN) n.d6o Patent Application Publication Jul. 10, 2014 Sheet 24 of 30 US 2014/0193460 A1 ÁpngsgoMaaM. (obo) Jaujodpu LI‘??, Patent Application Publication Jul. 10, 2014 Sheet 25 of 30 US 2014/0193460 A1 (Alpui + ueeW) 9 OOS 9SeeSO 9 now peuluns Patent Application Publication Jul. 10, 2014 Sheet 26 of 30 US 2014/0193460 A1 (Apu + ueeW) ?idbo s to it w Y. N. v co (Apu + ueeW) n-dfo Patent Application Publication Jul. 10, 2014 Sheet 27 of 30 US 2014/0193460 A1 d w N ve (Apu) fo efueleuoe Soda Alec as as w w to as (Apu) fo afueletoe soda Aed (Apu) n-defol afueletoax soda Áed Patent Application Publication Jul. 10, 2014 Sheet 28 of 30 US 2014/0193460 A1 Patent Application Publication Jul. 10, 2014 Sheet 29 of 30 US 2014/0193460 A1 (Apu) + ueeW) eIOOS 99eeSO 9, now peLulunS O O - CN CO W () Patent Application Publication Jul. 10, 2014 Sheet 30 of 30 US 2014/0193460 A1 (Apu + lueey) n.ddbo (Apu + lueey) Bo US 2014/0193460 A1 Jul. 10, 2014 HERPES VIRUS VACCNE AND METHODS OF lates with an increase in HSV-2 shedding (Schacker, T. et al., USE J. Infect. Dis., 178:1616-1622 (1998)). In addition, a prophy lactic vaccine eliciting neutralizing antibody responses did CROSS-REFERENCES TO RELATED not result in Sterilizing immunity (Corey, L. et al., J. Amer: APPLICATIONS Med. Assoc., 282:331-340 (1999)). Human studies have also 0001. This application is a continuation of International unveiled the role of CD8+ cytotoxic T cells in reducing Patent Application No. PCT/US2012/045290, filed Jul.
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