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1 Understanding Herpes Zoster & the Critical Importance of Herpes Zoster Vaccine W. Paul McKinney, MD University of Louisville.

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Presentation on theme: "1 Understanding Herpes Zoster & the Critical Importance of Herpes Zoster Vaccine W. Paul McKinney, MD University of Louisville."— Presentation transcript:

1 1 Understanding Herpes Zoster & the Critical Importance of Herpes Zoster Vaccine W. Paul McKinney, MD University of Louisville

2 2 Pre-Test Questions

3 3 ?

4 4 Which of the following is/are true statements? 1.Herpes zoster results from the reactivation of the varicella-zoster virus (VZV). 2.More than 90% of US adults are susceptible to zoster. 3.Estimated 1 million cases per year in the United States. 4.Incidence and severity of zoster increase with advancing age. 5.All of the above

5 5 The preferred rapid test for distinguishing between H. simplex and H. zoster is: 1.Viral culture 2.Direct fluorescent antibody (DFA) 3.Tzanck prep 4.Wright stain 5.None of the above

6 6 Which of the following reasons is/are valid for recommending against use of Herpes Zoster Vaccine? 1.History of anaphylaxis to neomycin 2.Daily use of 5 mg Prednisone 3.Insulin-requiring diabetes mellitus 4.All of the above

7 7 You see a 64 year old man with a diagnosis of melanoma, currently on a course of chemotherapy. Which of the following is a valid reason for deferring herpes zoster vaccine in this situation? 1.A prior history of shingles 2.Current chemotherapy 3.Symptoms of a cold with temperature of F. 4.All of the above 5.None of the above

8 8 You are advising one of your patients about receiving herpes zoster vaccine. She has several grandchildren and a pregnant daughter. Which of the following is a true statement concerning risk of transmission after vaccination? 1.Transmission of the vaccine virus has been reported in clinical trials. 2.There is a theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox. 3.There is no risk of transmitting the attenuated vaccine virus to a susceptible individual. 4.None of the above

9 9 Understanding Herpes Zoster: The Disease

10 10 1. How many of you have had chickenpox (varicella)? 2. How many of you are at risk for herpes zoster?

11 11 Diagnosis of Zoster © Diepgen TL, Yihune G et al. Dermatology Online Atlas (www.dermis.net). Reprinted with permission. Dermatomal distribution of rash Grape-like clustering of lesions © Phototake. Reprinted with permission. Image courtesy of Thomas P. Habif, MD.

12 12 The Family of Human Herpes Viruses (HHV) HHV-1H. simplex 1 HHV-2H. simplex 2 HHV-3Varicella-zoster virus HHV-4Epstein-Barr virus HHV-5Cytomegalovirus HHV-6Roseola infantum/exanthem subitum/Sixth Disease HHV-7ES (?) HHV-8Kaposis sarcoma

13 13 Electron Micrograph: VZV

14 14 EM: VZV Image courtesy of Dr. Frank Fenner, John Curtin School of Medical Research, Australian National University, Canberra, Australia.

15 15 Clinical Features of Zoster Tends to be less severe in children, young adults Prodrome with headache, photophobia, abnormal skin sensations/pain may precede rash by days/weeks Pain may be dull, burning, throbbing, stabbing or tingling and lead to misdiagnosis: MI, renal/gallstones, appendicitis Above symptoms may occur without subsequent rash: zoster sine herpete Rash is unilateral, present in 1-2 adjacent dermatomes Thoracic, cervical, ophthalmic regions most common Rash appears as progression… maculopapules vesicles clusters pustules ulcers crusts …And lasts 7-10 days, healing in 2-4 wks

16 16 Risk Factors for Zoster 1 Prior chickenpox infection: % of Americans Advancing age and declining cell-mediated immunity (CMI) –VZV-specific immunity declines with age –Altered CMI may also be due to immunosuppressive illness or medical treatments Gnann JW, Whitley RJ. N Engl J Med. 2002;347:340–346.

17 17 Epidemiology of Herpes Zoster Herpes zoster (shingles) results from the reactivation of the varicella-zoster virus (VZV). 1 More than 90% of US adults are susceptible to zoster. 1 –There is no way to predict who will develop zoster. 2 Estimated 1 million cases per year in the United States 3 Incidence and severity of zoster increase with advancing age 1,4 –Of the estimated 1 million cases per year, approximately 40% to 50% occur in individuals 60 years of age. 3 –By 85 years of age, approximately 50% of individuals will have had zoster. 5 –Lifetime risk may be as high as 20% 5 or even 33% 1. Gnann JW, Whitley RJ. N Engl J Med. 2002;347:340– Whitley RJ. In: Watson CPN, Gershon AA, eds. Herpes Zoster and Postherpetic Neuralgia, 2nd Revised and Enlarged Edition. Vol 11. Amsterdam, The Netherlands: Elsevier Science B.V.: 2001:65– Insinga RP, Itzler RF, Pellissier JM, Saddier P, Nikas AA. J Gen Intern Med. 2005;20:748– Arvin AA. Fields Virology. 4th ed. Vol 2. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:2731– Schmader KE. Clin J Pain. 2002;18:350–354.

18 18 Zoster Incidence Age (years)0–1415–2930–3940–4950–5960–6970–79 80 Cases (N=9,152) ,2131,9891,7781, *Age-specific incidence rates (across both sexes) from a healthcare claims database of more than 2.8 million individuals for the years 2000–2001 were sex adjusted to the 2000 US population. Insinga RP, Itzler RF, Pellessier JM, Saddier P, Nikas AA.J Gen Intern Med. 2005;20:748–753.

19 19 The Aging Population Source: US Bureau of the Census MaleFemale (Age) Percentage of total population 1990 MaleFemale (Age) Percentage of total population 2020 MaleFemale (Age) Percentage of total population Baby Boomers

20 20 Other Specific Risks for Zoster Early infection (age < 2 months) increases risk of zoster by age 12 by factor of 30+ Varicella vaccine: –Risk for zoster in immune compromised recipients of varicella vaccine is reduced by 2/3 –Risk of zoster for immunocompetent recipients of varicella vaccine likely lower, but long term followup in progress –Incidence in women in 11 to 35% higher Incidence in African Americans is 54-75% lower than whites No clear seasonal pattern Linkage to stress is uncertain

21 21 Zoster Risk Among the Immunocompromised Among persons with solid or hematologic tumors, Hodgkins Disease pts at especially high risk: 27% High rates among stem cell transplant (13-55%) and solid organ transplant recipients (5-17%). Incidence highest just after transplant. Most cases occur within 1 year. HIV+ patients have times the incidence of zoster of HIV- persons; risk even higher among children Persons with SLE, RA, Crohns, UC are at higher risk, probably due to immunosuppressive treatment

22 22 The Effect of Re-Exposure to VZV Ongoing exposure to chickenpox, zoster may reduce an individuals risk for zoster: Study in the UK showed 74% reduction in zoster risk for those with 3-4 varicella contacts compared to none over a 10 year period Another British study showed 25% decrease in zoster incidence for adults living with children, with effect persisting for 20 years Conflicting evidence for this is higher zoster incidence in women and a Japanese study showing no effect of repeated exposures in children

23 23 Risk of Recurrent Zoster Olmsted County, MN study showed no evidence that one episode of zoster reduces the subsequent recurrence rate: –24 of 1669 persons with zoster over 6 yr period have another episode

24 24 Hospitalization and Death Rates Again in Olmsted Co, 3% of zoster pts hospitalized Almost all zoster deaths are in the elderly, who have a 10x higher mortality Overall: –8.7% death rate among the immune compromised –3.7% death rate among the immunocompetent

25 25 Latency of VZV Established after Primary Infection (Chickenpox) Established by retrograde axonal transport of virus from skin to dorsal root ganglia Present in 1% to 7% of sensory ganglion neurons Each ganglion cell has <10 viral genomic copies Intensity of primary infection linked to latency burden

26 26 VZV Latency Maintained by Cell-Mediated Immunity (CMI) CMI effectiveness maintained through immunologic boosting –Endogenous boosting: Clinical or subclinical reactivation –Exogenous boosting: exposure to other active cases Anti-VZV Ab levels per se are not critical in preventing re-activation: –Rather, rise in Ab levels and presence and rise in CD4 T-cells after immunization are predictive of protection

27 27 Reactivation of VZV Advances in the Treatment and Prevention of Herpes Zoster and Postherpetic Neuralgia Lawrence D. Gelb, MD Michael D. Hogue, PharmD, Myron J. Levin, MD

28 28 Zoster Complications Image courtesy of Charles E. Crutchfield III, MD. Zoster Ophthalmicus Occurs in 10-25% of zoster cases Keratitis in 2/3 of these Scarring and visual loss may result Refer to ophthalmologist 1. Pavan-Langston D. In: Watson CPN, Gershon AA, eds. Herpes Zoster and Postherpetic Neuralgia, 2nd Revised and Enlarged Edition. Vol 11. Amsterdam, The Netherlands: Elsevier Science B.V.;2001:119–129.

29 29 Other VZV Complications Ramsay Hunt Syndrome: peripheral CN7 palsy found with vesicular lesions on tongue, hard palate or ear –may also have vertigo, hearing/taste loss, tinnitus –results from geniculate ganglion reactivation Motor weakness, autonomic dysfunction, focal neurologic deficits may be seen Rarely, myelitis, aseptic meningitis, meningoencephalitis also occur

30 30 VZV in Immunocompromised Hosts Tend to have more severe and prolonged rash Up to 1/3 may have true cutaneous dissemination Disssemination is a marker for viremia that may involve lungs, liver, GI tract, brain…resulting in case fatality rate of 5-15% Risk for neurologic complications greatly increased Risk for PHN is no different HIV pts: less severe features and lower rate of visceral dissemination than other compromised hosts –May develop unique complication: acute retinal necrosis, blindness

31 31 Diagnosing VZV Not usually required in classic clinical cases, but when needed: Tzanck smears for multinuclear giant cells: positive also in herpes simplex Viral cultures take several days, may be falsely negative Direct fluorescent Ab (DFA) of lesion scraping or biopsy is sensitive and fast Polymerase chain reaction (PCR) for viral DNA also rapid, sensitive, but less available

32 32 Transmission of Zoster Vesicles have high concentrations of VZV Contagious from eruption until crusting Zoster much less transmissible than chickenpox: Infection rates 15% vs 70% Transmission between pts and from pt healthcare workers seen in hospital. Transmission from healthcare workers to pts NOT seen Covered lesions much less likely to transmit infection

33 33 Healthcare Personnel with Zoster Avoid all contact with pregnant women, premature/low birth weight infants, and immuncompromised pts until lesions crust. Some hospitals exclude workers from any pt contact until lesions crust.

34 34 Acute Zoster-Associated Pain Prodrome May precede the rash by variable period Occurs in the majority of zoster patients 60 years of age and older 2 May lead to misdiagnosis Acute pain Pain often described as sharp, stabbing, throbbing, burning, itching, or hot. 1. Gnann JW, Whitley RJ. N Engl J Med. 2002;347:340– Oxman MN. In: Arvin AM, Gershon AA, eds. Varicella-Zoster Virus, Virology and Clinical Management. Cambridge, UK. Cambridge University Press; 2000: 246–275.

35 35 Postherpetic Neuralgia (PHN) Postherpetic neuralgia (PHN) is a potentially debilitating sequela of zoster, 1 persisting for months or years. 2 No consensus on duration of ongoing pain to define PHN: 30 days to 6 months post rash May result from axonal/cell body degeneration, scarring of dorsal root ganglion Common features of PHN include either constant or episodic pain and allodynia (pain provoked by innocuous stimuli). 3 –Allodynia is present in approximately 55% of acute zoster patients, but may affect up to 90% of patients with postherpetic neuralgia Oxman MN. In: Arvin AM, Gershon AA, eds. Varicella-Zoster Virus: Virology and Clinical Management. Cambridge, UK: Cambridge University Press; 2000:246– Gnann JW, Whitley RJ. N Engl J Med. 2002;347:340– Dworkin RH, Portenoy RK. Pain. 1996;67:241– Bowsher D. In: Watson CPN, Gershon AA, eds. Herpes Zoster and Postherpetic Neuralgia, 2nd Revised and Enlarged Edition. Vol 11. Amsterdam, The Netherlands: Elsevier Science B.V.; 2001:143–147.

36 36 Risk Factors for PHN Age is primary risk factor: Persons over 50 are 27x more likely to have PHN than those under 50 About 80% of PHN patients are age 50 and over PHN incidence rate among zoster patients: 18%, 13%, and 10% based on cutoff of 30, 60, 90 day pain duration in Olmsted County 30%, 18%, 13% in placebo group of zoster vaccine study

37 37 Comparison of Pain Scores for Various Conditions Acute Pain Conditions Chronic Pain Conditions Less Pain More Pain Katz and Melzack compared total pain rating index scores from multiple studies of chronic pain and acute pain of diverse causes, using the Short-form McGill Pain Questionnaire. Pain scale indexes ranged from 0 to Abdominal hysterectomy Acute headache Zoster Labor pain Postsurgical pain Mucositis Angioplasty sheath removal Postherpetic neuralgia Chronic cancer pain Fibromyalgia Rheumatoid arthritis Osteoarthritis Arthritis Musculoskeletal pain Atypical facial pain Adapted from Surgical Clinics of North America, Vol 79, Katz J, Melzack R, Measurement of Pain, pp 231–252. Copyright ©1999, with permission from Elsevier.

38 38 Treatment of Zoster and PHN Acyclovir, famciclovir, valacyclovir all FDA approved for zoster in immune competent pts: all reduce duration of shedding, number of lesions, time to healing, severity/duration of pain and risk for PHN. (All studies started tx within 72 hrs.) Corticosteroids (3 wk oral tapering dose) PLUS acyclovir: reduced acute pain and time to healing, but no additive effect vs risk of PHN. No effect of topical steroids Keep lesions clean/dry, avoid topical antibiotics routinely, cover lesions

39 39 Treatments for Zoster Pain and Postherpetic Neuralgia Zoster Antivirals, as stated Analgesics 2 –Non-narcotics –Narcotics Postherpetic neuralgia Analgesics 1 –Non-narcotics –Narcotics Topical agents 1 Anticonvulsants 1 Consultation with a pain management specialist may be necessary 1 1. Gnann JW, Whitley RJ. N Engl J Med. 2002;347:340– Stankus SJ, Dlugopolski M, Packer D. Am Fam Physician. 2000;61:2437–2444.

40 40 Summary Reactivation of varicella-zoster virus results in zoster (shingles), which is characteristically dermatomal in distribution. 1 An estimated 1 million cases of zoster occur annually in the United States. 2 –There is no way to predict who will develop zoster. 3 Advanced age and waning cell-mediated immunity are defined risk factors. 1 Postherpetic neuralgia is one of the most severe complications of zoster Straus SE, Oxman MN. In: Freedberg IM, Eisen AZ, Wolff K, et al, eds. Fitzpatricks Dermatology in General Medicine. 5th ed. Vol 2. New York, NY: McGraw-Hill; 1999:2427– Insinga RP, Itzler RF, Pellisier JM, Saddier P, Nikas AA. J Gen Intern Med. 2005: Whitley RJ. In: Watson CPN, Gershon AA, eds. Herpes Zoster and Postherpetic Neuralgia 2nd Revised and Enlarged Edition. Vol 11. Amsterdam, The Netherlands, Elsevier Science B.V.; 2001:65– Oxman MN. In: Arvin AM, Gershon AA, eds. Varicella-zoster virus, virology and clinical management. Cambridge, UK: Cambridge University Press;2000:246–275.

41 41 The Critical Importance of Herpes Zoster Vaccine

42 42 Description Lyophilized preparation of the Oka/Merck strain of live, attenuated VZV. Each 0.65-mL dose contains a minimum of 19,400 plaque-forming units (PFU), or 14x the potency of varicella vaccine Several excipients: porcine gelatin, residual MRC-5 cell DNA, protein; trace neomycin & bovine calf serum; NO thimerosal or other preservatives Administer subcutaneously in deltoid region No booster dose licensed

43 43 Herpes Zoster Vaccine HZV is indicated for the prevention of herpes zoster (shingles) in individuals 60 years of age and older. HZV has no role in the treatment of zoster or postherpetic neuralgia (PHN).

44 44 Clinical Pharmacology: The Shingles Prevention Study Design Subjects Enrolled N=38,546 Age 60 to 69 years n=20,747 Age 70 years n=17,799 Zoster vaccine n=10,378 Placebo n=10,369 Zoster vaccine n=8,892 Placebo n=8,907 Adverse Event (AE) Substudy n=6,616 Immunogenicity Substudy n=1,395 Oxman MN, Levin MJ, Johnson GR, et al. N Engl J Med. 2005;352:2271–2284.

45 45 Patient Demographics in the Shingles Prevention Study Characteristic Vaccine Group N=19,270 Placebo Group N=19,276 Age n (%) 60 to 69 years10,378 (53.9)10,369 (53.8) 70 years 8,892 (46.1)8,907 (46.2) Gender n (%) Male11,403 (59.2)11,357 (58.9) Female7,867 (40.8)7,919 (41.1) Race n (%) White18,393 (95.4)18,381 (95.4) Black395 (2.0)420 (2.2) Hispanic265 (1.4)248 (1.3) Other or unknown217 (1.1)227 (1.2) Oxman MN, Levin MJ, Johnson GR, et al. N Engl J Med. 2005;352:2271–2284.

46 46 Prevention of Herpes Zoster Number of zoster cases Age (years) –64% (95% CI: 56%, 71%) –41% (95% CI: 28%, 52%) –18% (95% CI: –29%, 48%) Overall 60–6970–7980 Placebo HZV –51% (95% CI: 44%, 58%) Incidence rate of zoster per 1,000 person-years

47 47 Postherpetic Neuralgia* in the Shingles Prevention Study *Zoster-associated pain rated as 3 on a 10-pt scale and occurring or persisting at least 90 days after rash onset. Age-adjusted estimate based on the age strata (60-69 and 70 years of age) at randomization. 0 Overall60–6970–7980 Age (years) Number of PHN Cases % of Zoster Cases with Postherpetic Neuralgia –5% (95% CI: –107%, 56%) –55% (95% CI: 18%, 76%) –26% (95% CI: –69%, 68%) –39% (95% CI: 7%, 59%) Placebo HZV Number of HZ Cases

48 48 Immunogenicity VZV specific immunity rises 6 wks after vaccine, not placebo Degree of immune response directly correlates with protection No Ab threshold for protection evident CMI responses higher in persons under 70

49 49 Duration of Efficacy Efficacy declines in year 1 but then stable through year 3

50 50 Specific Complications* of Zoster Among Zoster Cases in the Shingles Prevention Study Complication Herpes Zoster Vaccine (N = 19,270) Placebo (N = 19,276) ( n = 321) % Among Zoster Cases (n = 659) % Among Zoster Cases Allodynia Bacterial Superinfection Dissemination Impaired Vision Ophthalmic Zoster Peripheral Nerve Palsies (motor) Ptosis Scarring Sensory Loss N=number of subjects randomized n=number of zoster cases, including those cases occurring within 30 days postvaccination, with these data available *Complications reported at a frequency of 1% in at least one vaccination group among patients with zoster.

51 51 Economic Burden and Cost-Effectiveness (CE) Five studies estimated CE of 1 dose of HZV For vaccine cost of $150, costs were $27,000 to $112,000 per quality-adjusted life year gained. Result was sensitive to variations in vaccine cost, duration of efficacy, risk of PHN, costs and quality of life scores for zoster and complications World Health Organization suggests CE threshold of 3x Gross Domestic Product per capita ($94,000 for USA)

52 52 Adverse Reactions HZV was evaluated for safety in approximately 21,000 adults. Shingles Prevention Study Routine safety monitoring –HZV: n = 15,925; placebo: n = 16,005 –Patients were actively followed for safety outcomes through Day 42 postvaccination. –Subjects were followed passively for safety after Day 42 postvaccination to the end of the study. AE Monitoring Substudy –HZV: n = 3,345; placebo: n = 3,271 –Vaccination report cards used to record AEs for 42 days postvaccination –Monthly surveillance for hospitalization 2 to 5 years postvaccination

53 53 Number of Subjects With 1 Serious Adverse Experience (0–42 Days Postvaccination) in the Shingles Prevention Study Cohort HZV n/N % Placebo n/N % Relative Risk (RR) (95% CI) Overall Study Cohort (all ages) 255/18, % 254/18, % 1.01 (0.85, 1.20) 60–69 years old113/10, % 101/10, % 1.12 (0.86, 1.46) 70–79 years old115/7, % 132/7, % 0.87 (0.68, 1.11) 80 years old27/1, % 21/1, % 1.36 (0.78, 2.37) AE Monitoring Substudy Cohort (all ages) 64/3, /3, (1.04, 2.25) 60–69 years old22/1, % 18/1, % 1.21 (0.66, 2.23) 70–79 years old31/1, % 19/1, % 1.61 (0.92, 2.82) 80 years old11/ % 4/ % 2.19 (0.75, 6.45) N = number of subjects in cohort with safety follow-up n = number of subjects reporting an SAE 0–42 days postvaccination

54 54 AE Monitoring SubstudyEntire Study Cohort HZV N = 3,326 Placebo N = 3,249 HZV N = 18,671 Placebo N = 18,717 n (%) Overall cardiovascular events by body system 20 (0.6)12 (0.4)81 (0.4)72 (0.4) Coronary artery disease-related conditions * 10 (0.3)5 (0.2)45 (0.2)35 (0.2) N=number of subjects with safety follow-up n=number of subjects reporting SAE within the category * CAD-related conditions: angina pectoris, coronary artery disease, coronary occlusion, cardiovascular disorder, myocardial ischemia, & myocardial infarction Selected Serious Adverse Experiences (SAE) Reported More Frequently After HZV than After Placebo Days 0–42 Postvaccination in the Shingles Prevention Study

55 55 Injection-Site and Systemic Adverse Experiences Adverse Experience HZV (n = 3,345) % Placebo (n = 3,271) % Injection Site Erythema* Pain/tenderness* Swelling* Hematoma Pruritus Warmth Systemic Headache Reported by vaccine report card in 1% of adults who received ZOSTAVAX or placebo (0 to 42 days postvaccination) in the AE monitoring substudy of the Shingles Prevention Study *Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0–4 postvaccination.

56 56 Adverse Events Occurring After Day 42 Postvaccination AE Monitoring Substudy subjects in the Shingles Prevention Study were monitored for hospitalizations through monthly automated phone queries and the remainder of subjects were passively monitored for safety in this study from Day 43 postvaccination through study end. Over the course of the study (4.9 years), 51 individuals (1.5%) receiving HZV were reported to have congestive heart failure (CHF) or pulmonary edema compared to 39 individuals (1.2%) receiving placebo in the AE Monitoring Substudy; 58 individuals (0.3%) receiving HZV were reported to have congestive heart failure (CHF) or pulmonary edema compared to 45 (0.2%) individuals receiving placebo in the overall study.

57 57 Summary: ACIP Rationale for Zoster Vaccine Recommendations 1.Zoster causes substantial morbidity in US: 1 million cases per year, with risk of severe complications 2. Antiviral therapy only partially effective and time dependent. 3.Therapy for PHN inadequate for many 4.HZV appears cost effective by usual comparison 5.Vaccine efficacious, based on reduction in incidence of zoster (51%), PHN (65%), and overall burden of illness (61%) 6.Efficacy, though somewhat reduced, is still present even in oldest age groups

58 58 ACIP Recommendations for Use of HZV 1.All persons aged 60 and over, unless specifically contraindicated. (NOT licensed for those under 60). Prior history of zoster and most chronic medical conditions do not alter the recommendation. 2.Use simultaneously or 4 wks after other live viral vaccines. Non-live vaccines (Td, Tdap, influenza, pneumococcal 23) may be given with, or anytime before or after HZV. 3.Not recommended for those who received varicella vaccine. (This excludes extremely few persons)

59 59 Recommendations for HZV--continued 4. Consider for those anticipating immune suppression with chemotherapy, etc (give HZV at least days in advance) 5. Hold antivirals for at least 24 hrs before vaccination. If vaccinated first, use antivirals no earlier than 14 days later. 6. Receipt of blood products not a problem, since pre- existing Ab does not diminish response.

60 60 ?

61 61 Clinical Management Case 1 The major reason given by patients as to why they do not receive recommended vaccines is: 1.Failure to receive a physician recommendation 2.Fear of needles 3.Concern about costs 4.Worries about side effects

62 62 Clinical Management Case 2 Reasons for deferring immunization with Herpes Zoster Vaccine in a 68 yo African American female include: 1.A prior history of shingles 2.Current treatment with chemotherapy for breast cancer 3.Symptoms of a cold with temperature of F. 4.All of the above

63 63 Contraindications to HZV 1.Anaphylactic reaction hx to any component (usually neomycin or gelatin) 2.Persons with primary or acquired immune deficiency: leukemia, lymphoma, AIDS or HIV+ with CD4<200 High dose steroids (20 mg/d prednisone for 2 weeks or more) Stem cell transplant Immune modulators: TNF agents like inflixamab, etanercept Note: Gamma globulin disorders NOT a contra 3. Pregnancy: rare in the 60+ population 4. Postpone if acute, moderate to severe illness

64 64 Selected Precautions Transmission Transmission of the vaccine virus has not been reported in clinical trials. Postmarketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts. Transmission of vaccine virus from varicella vaccine recipients without a VZV-like rash has been reported but has not been confirmed. Vaccinees should be informed of the theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox.

65 65 Conditions for Storage HZV STORE FROZEN at an average temperature of –15°C (+5°F) or colder until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of –15°C or colder is acceptable. Measure and record temp twice per day. Diluent Store diluent separately at room temperature (20°C to 25°C, 68°F to 77°F) or in refrigerator (2°C to 8°C, 36°F to 46°F).

66 66 Dosage and Administration For Subcutaneous Administration: deltoid region: Single Dose Reconstitution procedure Reconstitute immediately upon removal from freezer. To reconstitute, first withdraw entire contents of diluent vial into a syringe; inject all the diluent into a vial of lyophilized vaccine; gently agitate to mix thoroughly.

67 67 Administration Injection procedure: Withdraw entire contents of reconstituted vaccine into a syringe. Inject total volume SC, preferably into upper arm. Administer immediately after reconstitution. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.

68 68 Consider Vaccinating Appropriate Patients in Your Practice

69 69 Adult Vaccination Schedule

70 70 Good General Immunization Practices Link HZV to other indicated vaccinations: eg influenza Use standing orders to facilitate implementation Nursing home/chronic care facility patients should be included Report adverse events after vaccination to VAERS: FDAs Vaccine Adverse Event Reporting System: telephone, web-based access Report any administration errors to VAERS: eg, giving HZV instead of varicella vaccine to a child. Varicella vaccine NOT indicated for prevention of zoster.

71 71 Physician Barriers to Vaccination Vaccine Issues Patients vaccine safety concerns Practical issues Urgent medical concerns No patient immunization history Education Ambiguous vaccination guidelines Lack of patient-oriented vaccine information Cost Inadequate reimbursement Szilagyi PG, Shone LP, Barth R, et al. Prev Med. 2005;40:152–161.

72 72 Patient Barriers to Vaccination Did not know the shot was needed Doctor did not recommend the shot Did not think of it/missed it Thought the shot could cause the disease Thought the shot would have side effects Did not think the shot would prevent disease Do not like shots or needles Shot not worth the money Centers for Disease Control and Prevention. MMWR. 1999;48:886–890.

73 73

74 74 Screening Questionnaire for Adult Immunization Are you sick today? Do you have allergies to medications, food, or any vaccine? Have you ever had a serious reaction after receiving a vaccination? Do you have cancer, leukemia, AIDS, or any other immune system problem? Do you take cortisone, prednisone, other steroids, or anticancer drugs, or have you had x-ray treatments? During the past year, have you received a transfusion of blood or blood products, or been given a medicine called immune (gamma) globulin? For women: Are you pregnant or is there a chance that you could become pregnant within the next 3 months? Have you received any vaccinations in the past 4 weeks? Adapted from the Immunization Action Coalition. Available at: YesNoDont know

75 75 Standards for Adult Immunization Practices Make vaccinations available Identify and minimize barriers Assess patients vaccination status Communicate effectively with patients Educate patients about the risks and benefits of vaccination Administer and document vaccinations properly Develop office protocols Implement strategies to improve vaccination rates Patient reminders Partner with the community Poland GA, Shefer AM, McCauley M, Webster PS, Whitley-Williams PN, Peter G, and the National Vaccine Advisory Committee. Am J Prev Med. 2003;25:144–150.

76 76 Clinical Practice Recommendation Practice Recommendation: Zoster vaccine is recommended for all adults age 60 and above. Evidence-Based Source: National Guidelines Clearinghouse Web Site of Supporting Evidence: &string=zoster+AND+vaccine Strength of Evidence: Class A: Randomized, controlled trial; Class M: Meta-analysis, Systemic review, Decision analysis, Cost-effective analysis; Class R: Consensus statement, Consensus report, Narrative review

77 77 Clinical Practice Recommendation Practice Recommendation: A history of prior shingles disease is not a contraindication to immunizing patients over age 60 against zoster/shingles. Evidence-Based Source: Institute for Clinical Systems Improvement Web Site of Supporting Evidence: Strength of Evidence: Class A: Randomized, controlled trial; Class M: Meta-analysis, Systemic review, Decision analysis, Cost-effective analysis; Class R: Consensus statement, Consensus report, Narrative review

78 78 Post-Test Questions

79 79 ?

80 80 Which of the following is/are true statements? 1.Herpes zoster results from the reactivation of the varicella-zoster virus (VZV). 2.More than 90% of US adults are susceptible to zoster. 3.Estimated 1 million cases per year in the United States. 4.Incidence and severity of zoster increase with advancing age. 5.All of the above

81 81 The preferred rapid test for distinguishing between H. simplex and H. zoster is: 1.Viral culture 2.Direct fluorescent antibody (DFA) 3.Tzanck prep 4.Wright stain 5.None of the above

82 82 Which of the following reasons is/are valid for recommending against use of Herpes Zoster Vaccine? 1.History of anaphylaxis to neomycin 2.Daily use of 5 mg Prednisone 3.Insulin-requiring diabetes mellitus 4.All of the above

83 83 You see a 64 year old man with a diagnosis of melanoma, currently on a course of chemotherapy. Which of the following is a valid reason for deferring herpes zoster vaccine in this situation? 1.A prior history of shingles 2.Current chemotherapy 3.Symptoms of a cold with temperature of F. 4.All of the above 5.None of the above

84 84 You are advising one of your patients about receiving herpes zoster vaccine. She has several grandchildren and a pregnant daughter. Which of the following is a true statement concerning risk of transmission after vaccination? 1.Transmission of the vaccine virus has been reported in clinical trials. 2.There is a theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox. 3.There is no risk of transmitting the attenuated vaccine virus to a susceptible individual. 4.None of the above


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