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New Vaccines Zostavax® & Cervarix®

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New Vaccines Zostavax® & Cervarix® In the last 12 months, Fred Y. Aoki has participated in clinical trials or drug studies funded by GlaxoSmithKline (GSK), Roche and BioCryst, been a speaker at Continuing Medical & Health Education meetings sponsored by GSK and Merck and served on Advisory Boards for GSK & Roche Review the efficacy & safety of Zostavax® and Cervarix® Identify target populations for Cervarix® and Herpes zoster (HZ) vaccines Manage safe & effective vaccine storage in the pharmacy and office A vaccine that can help prevent shingles in adults 60 years of age and older Annual Incidence of Herpes Zoster by Age Decile per 1000 Manitobans 2003/04 14 12 10 8 6 Incidence per 1000 4 2 0 0-9 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80+ Age (years) •By age 85 yrs, 25% will experience an episode of HZ 1. Acute pain until the HZ rash heals, approximately 4 weeks 2. In HZ ophthalmicus, ocular damage including vision impairment and facial scarring 3. Post-herpetic neuralgia (PHN) The most common problem A therapeutic challenge Amitrytiline1 Gabapentin2 Topical Capsaicin3 Lidocaine4 Transcutaneous nerve stimulation5 1. Watson et al. J Neurol 1982; 32:671 2. Rowbotham et al. JAMA 1998; 280:1837 3. Watson et al. Pain 1988; 33:33 Acyclovir, famciclovir & valacyclovir Must be initiated less than 72 H after rash onset for non-ophthalmic zoster Cochrane Systematic Review: Acyclovir not effective Efficacy of famciclovir & valacyclovir not yet established Li et al. Cochrane Systematic Review 2009 Corollary: An HZ virus vaccine may boost immunity like natural exposure to chickenpox & thus prevent HZ Hope-Simpson RE. Proc R Soc Med 1965 Randomized, double-blind, placebo-controlled trial Zoster ophthalmicus of < 7 days duration Acyclovir 600 mg 5x/d x 10 days Acyclovir reduced complications by 58% Cobo et al. Ophthalmol 1986; 93:763 Treat all cases < 7 days’ duration with acyclovir 600 mg five times/day for 10 days Consult ophthalmologist Vaccine type: Live attenuated OKA/MERCK VZV vaccine (Zoster Vaccine) Administration: Subcutaneous injection The minimal potency of the Zoster Vaccine was at least 14 times greater than the Varicella live attenuated Oka/Merck VZV vaccine. Oxman M et al. N Engl J Med 2005; 352:2271 6 VE =51% Placebo (n=642) HZ 5 p<0.001 4 3 2 1 Zoster Vaccine (n=315) 0 0 1 2 3 4 Years of follow-up Cumulative Cumulative Incidence of HZ (%) Oxman M et al. N Engl J Med 2005; 352:2271 0.8 Placebo (n=80) VE PHN =67% 0.6 p<0.001 0.4 0.2 Zoster vaccine (n=27) 0.0 Per 1000 patient years patient 1000 Per 0 1 2 3 4 Cumulative Cumulative Incidence of PHN Years of follow-up Oxman M et al. N Engl J Med 2005; 352:2271 Vaccine Placebo Pain or 35% 9% tenderness Redness 36% 7% Swelling 26% 5% Oxman et al. N Engl J Med 2005; 352:2271 The HZ vaccine reduced the incidence of HZ by 51% The incidence of PHN was reduced by 67% Well tolerated Recommended for prevention of HZ and its sequelae in adults > 60 years of age by both NACI & CDC Freezer stable › Store at less than -15 C › Store diluent at room temperature or refrigerator › Inject within 30 minutes of reconstitution Single dose: 0.65 ml, subcutaneously in deltoid Contraindications › Immunosuppression › Pregnancy › Anaphylactic allergy to neomycin, gelatin A non-infectious, recombinant, adjuvanted vaccine consisting of the L1 protein of HPV types 16 and 18 Indicated for the prevention of cervical cancer caused by Human Papilloma Virus Types 16 & 18 in females 10-25 years of age Steady decline in 20 incidence of Incidence squamous cell Mortality 15 carcinoma but rates have 10 leveled off since 1995 5 Incidence Per 100,000 Per Incidence Novel prevention 0 strategies are 1977 1982 1987 1992 1997 2002 Year needed Benedet, et al. J Lower Genital Tract Disease 2005.9:160-166. Cumulative percentage 16 53.5 54 18 17.2 71 45 6.7 77 31 2.9 80 33 2.6 83 52 2.3 85 HPV genotype HPV 58 2.2 87 1.4 35 89 0 10 20 30 40 50 60 70 80 90 100 Muňoz N, et al. Int J Cancer 2004; 111:278–285. 50 15–19 40 20–24 25–29 Age at 30 baseline 30–44 20 45+ 10 HPV infection (%) year cumulative risk of risk cumulative year - 0 5 0 1 2 3 4 5 Follow-up time (years) • 75% are oncogenic HPV types 1. Munoz N, et al. J Infect Dis 2004; 190:2077–2087. Most HPV infections regress within 2 years 5–7% progress to CIN 2/3 within 2 years2,3 ~ 90% within 2 years1 Normal Infection CIN1 CIN2 CIN3 Invasive epithelium carcinoma Approximate likelihood of regression4 CIN 1: 57% CIN 2: 43% CIN 3: 32% Persistent HPV infection is required for development of cervical cancer 1. Ho GY, et al. N Engl J Med 1998; 338:423–428; 2. Moscicki AB, et al. J Pediatr 1998; 132:277–284; 3. Winer RL, et al. J Infect Dis 2005; 191:731–738; 4. Östor AG, et al. Int J Gyn Pathol 1993; 12:186–192; 5. Viscidi R, et al. Cancer Epidemiol Biomarkers Prev 2004; 13:324–327; CIN: Cervical intraepitelial lesion 6. Carter J, et al. J Infect Dis 2000; 181:1911–1919; 7. WHO. Weekly Epidemiological Record 2009; 84:117–132. 8. Huh W, et al. Obstet Gynecol 2009; 114:439-43 3 2.7 10,049 women Guanacaste, Costa Rica NCI Study 2.4 Seronegative Seropositive 2.1 specific specific - 1.8 1.5 1.2 0.9 HPV infections (%) infections HPV Rate of type Rate 0.6 0.3 0 19/ 11/ 1492 1490 HPV 16 HPV 18 HPV 31 1. Viscidi R, et al. Cancer Epidemiol Biomarkers Prev 2004; 13:324–327; 19/ 1492 2. Carter J, et al. J Infect Dis 2000; 181:1911–1919. • HPV partially evades the immune system • Yet most HPV infections are naturally cleared • Only 50% of women develop detectable antibodies after infection2 • Antibody after natural infection is not reliably protective2 • Vaccines against HPV need to improve upon natural immunity (1) Stanley M., 2006; Revaz V and Nardelli-Haefliger D, 2005 (2) Kjellberg L et al, 1999; Viscidi RP et al., 1997; Carter JJ et al., 2000; de Gruijl TD et al.,1997. (3) Villa L et al., 2005; Harper D et al, 2004; (4) Carter JJ et al., 1996. (5) Viscidi, 2004; Viscidi, 2005, Ho GY et al., 2002; Thomas KK et al., 2000. CervarixR1-4 Gardasil®** 5-7 Antigens 20 μg HPV-16 VLP 40 μg HPV-16 VLP 20 μg HPV-18 VLP 20 μg HPV-18 VLP 20 μg HPV-6 VLP 40 μg HPV-11 VLP Expression Baculovirus Saccharomyces system expression vector cerevisiae yeast Adjuvant AS04 225 μg amorphous [50 μg MPL and 500 aluminum **Gardasil is a registered trademark of Merck & Co Inc. μg Al(OH)3] hydroxyphosphate sulphate (AAHS) 1. Harper DM et al. Lancet 2004; 364:1757-65. 2. Harper DM et al. Lancet 2006; 367:1247-55. 3. Paavonen J et al. Lancet 2007;369:2161-70. 4. Harper DM et al. Gynecol Oncol 2008;109:158-9. 5. Villa LL et al. Lancet Oncol 2005;6:271-8. 6. Villa LL et al. Br J Cancer 2006;95:1459-66. 7. FUTURE II Study Group. N Engl J Med 2007;356:1915-27. The inclusion of HPV types 6 and 11 in the quadrivalent vaccine (GardasilR) prevents genital warts. The different adjuvant in the bivalent vaccine (CervarixR may be important in expanding cross- protection and durability of protection. CervarixR According-to-protocol Vaccine Control Vaccine efficacy efficacy cohort n = 7344 n = 7312 % 96.1% CI HPV-16/18 CIN2+* 1 53 98 80–98 *Analysis for causality. Paavonen J et al. Lancet 2009;374:301–14. GardasilR Per-protocol efficacy cohort Vaccine Control Vaccine efficacy n = 8493 n = 8464 % 95% CI HPV-16/18 CIN2+ 2 112 98 94–100 Canadian Gardasil product monograph Results are from 2 separate analyses. Not head-to-head trial data. CervarixR Vaccine efficacy Total vaccinated cohort (TVC)–naïve Vaccine Control % 96.1% CI HPV-31/45 CIN2+ 0 24 100 82–100 HPV-31/33/45/52/58 15 47 68 41–84 CIN2+ Paavonen J et al. Lancet 2009;374:301–14. Skinner R et al. Presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 2009 May 8–14. GardasilR Vaccine efficacy Generally naïve cohort Vaccine Control % 95% CI HPV-31/45 CIN2+ 11 27 59 14–82 HPV-31/33/45/52/58 44 66 32* 0–51* CIN2+ * Not statistically significant. Brown DR et al. J Infect Dis 2009;199:926–35. Results are from 2 separate studies. Not head-to-head trial data. Papillomavirus Phylogenetic Tree 40 39 70 59 7 32 44 55 42 PCV1 18 27 13 45 61 2a 11 57 6 73 3 34 28 10 RhPV1 29 58 33 51 52 26 16 30 53 35 56 31 66 • The alpha-papillomavirus genus of the papillomavirus phylogenetic tree is shown* * Selected species and types are shown. Adapted from de Villiers E, et al. Virology 2004; 324:17–27. CervarixR Control Reduction TVC-naïve cohort n = 5449 n = 5436 % 96.1% CI Colposcopy 354 476 26 15–36 referrals Cervical excisions 26 83 69 50–81 Paavonen J et al. Lancet 2009; 374:301-14 GardasiR Control Reduction Naïve cohort n = 4696 n = 4759 % 95% CI Colposcopy with 741 950 22 14–29 biopsy Definitive cervical 132 230 42 28–54 therapy Canadian Gardasil product monograph Results are from 2 separate studies.
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