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What are the new vaccination recommendations for herpes zoster?

Mospan, Cortney M., PharmD, BCACP, BCGP; Colvin, Natasha, PharmD

Journal of the American Academy of PAs: October 2018 - Volume 31 - Issue 10 - p 14–15
doi: 10.1097/01.JAA.0000545079.16968.0e
Pharmacology Consult

ABSTRACT A new vaccine to prevent herpes zoster (shingles) has been included in the 2018 Advisory Committee on Immunization Practices' adult immunization schedule as the preferred herpes zoster vaccination for all immunocompetent adults age 50 years and older. This article discusses new vaccination recommendations for herpes zoster.

Cortney M. Mospan is an assistant professor of pharmacy at Wingate (N.C.) University School of Pharmacy. Natasha Colvin is an assistant professor of pharmacy practice at South University School of Pharmacy in Columbia, S.C. The authors have disclosed no potential conflicts of interest, financial or otherwise.

Mary Lou Brubaker, PharmD, PA-C, department editor

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Nearly one in three adults will develop herpes zoster (shingles) during their lifetime; incidence increases with age.1 Annually, an estimated 1 million cases occur in the United States.2 Overall incidence is increasing, showing the importance of adequate vaccination protection to decrease disease incidence and burden.1 The most common and problematic complication of shingles is postherpetic neuralgia, or severe pain at the site of the shingles rash. Nearly 20% of patients report some pain at the rash location 3 months after shingles onset and 15% report pain at 2 years.1,3 The incidence of postherpetic neuralgia increases with patient age, from 8% in patients ages 50 to 54 years to 21% in patients ages 80 to 84 years.3 In October 2017, the FDA approved a new herpes zoster vaccine, a recombinant zoster vaccine (RZV) under the brand name Shingrix, which may better address shingles and its complications.4

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UNDERSTANDING THE NEW VACCINE

The new vaccine has two components—the varicella zoster virus (VZV) glycoprotein E antigen and an AS01B adjuvant—that must be reconstituted before being administered.5 The two components create a synergistic immune response because the glycoprotein E antigen, the primary surface protein of the VZV, is a strong elicitor of the immune response. The AS01B adjuvant enhances antigen-presenting cell activity to produce a strong and persistent CD4+ T-cell and humoral immune response against recombinant proteins.6 RZV is a two-dose vaccination series, with the second dose given any convenient time 2 to 6 months after the first dose. Although alternative dosing schedules have not been evaluated, restarting the series is not recommended if a patient misses the second dose. Rather, patients should be vaccinated with the second dose as soon as possible.7

The vaccine is approved for use in all immunocompetent adults age 50 years and older.5 Unlike ZVL (Zostavax), RZV is administered IM, and both vaccine components are stored in the refrigerator.5 Once reconstituted, the vaccine is stable for only 6 hours, so it should not be prepared until the patient is in the clinic and has been assessed for appropriateness.5 RZV can be coadministered with other adult vaccines, provided the vaccines are administered at different anatomical sites.7

Two clinical trials, ZOE-50 (patients age 50 years and older) and ZOE-70 (patients age 70 years and older) assessed the efficacy of RZV in patients not previously vaccinated with ZVL.6,8 RZV efficacy, defined as reduction of the risk of herpes zoster, was 97.2% in the ZOE-50 study and 89.8% in the ZOE-70 study. Trial duration was 3.2 years for ZOE-50 and 3.7 years for ZOE-70.6,8 Both results were statistically significant, and vaccine efficacy did not decline with increasing age as found with ZVL.6,8-10 Adverse reactions were common (84.4% and 79%) and occurred more frequently than in patients receiving ZVL (58.1%) but generally were mild.6,8,9 RZV also reduced the overall incidence of postherpetic neuralgia compared with placebo.8 Systemic adverse reactions generally are more severe with the second dose of RZV and common adverse reactions include localized pain (78%), myalgia (45%), fatigue (45%), redness at injection site (38%), shivering (27%), fever (21%), and swelling at the injection site (26%). Adverse reactions are less common in patients age 70 years and older.5,7

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WHY ZVL MAY NOT BE THE RIGHT ANSWER

ZVL was approved in 2006 for use in patients age 60 years and older for prevention of herpes zoster. In 2011, the FDA approved the vaccine for use in patients age 50 years and older but this reduced age was never recommended by the Advisory Committee on Immunization Practices (ACIP).7

In the years since ZVL was approved, researchers have found that its efficacy against herpes zoster and postherpetic neuralgia wanes with time. In the Shingles Prevention Study, ZVL had a 51.3% efficacy rate against herpes zoster in adults age 60 years and older. Efficacy was greater in preventing complications such as postherpetic neuralgia and burden of illness than it was in preventing the disease itself.9

In follow-up trials designed to assess prolonged efficacy, the efficacy of ZVL was found to continually decline. At 7 years, ZVL's efficacy against herpes was just 39.6%, and by 8 years, efficacy was equal to never having been vaccinated.10,11 Prevention of herpes zoster is connected to maintenance of a sustained cellular immune response of VZV-specific memory T cells. Patients with higher-memory T-cell counts have been found to have a lower incidence of herpes zoster. Anti-VZV antibodies have been found to not correlate with protection against herpes zoster.12 The RZV vaccine immunology allows for better stimulation of VZV-specific memory T cells, and may address ZVL's issues with prolonged efficacy.12

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PRACTICE IMPLICATIONS

In January 2018, the ACIP published final recommendations that were incorporated into the 2018 Adult Immunization Schedule.7,13 The ACIP has preferentially recommended RZV over ZVL for herpes zoster vaccination in adults age 50 years and older.12,13 This was due to substantially higher vaccine efficacy and better cost-effectiveness when analyses were performed by the CDC. Patients who have been previously vaccinated with ZVL should be revaccinated with the full two-dose RZV series. Table 1 compares the two vaccines. Although RZV is not a live vaccine (as is ZVL) and does not pose the risk of causing disease in immunocompromised patients, it should only be recommended to immunocompetent adults age 50 years and older. RZV's safety and efficacy has not been established in immunocompromised patients.7 Patients taking intranasal corticosteroids, inhaled corticosteroids, and less than 20 mg/day of prednisone (or equivalent dose) are not considered immunocompromised and can receive the vaccine.7 How well RZV's efficacy will be maintained is not known but studies are ongoing to assess long-term vaccine efficacy. The new vaccine offers hope for a considerable reduction in the herpes zoster burden in the United States.

TABLE 1

TABLE 1

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REFERENCES

1. Centers for Disease Control and Prevention. Shingles surveillance. http://www.cdc.gov/shingles/surveillance.html. Accessed July 18, 2018.
2. Centers for Disease Control and Prevention. Shingles (herpes zoster). http://www.cdc.gov/shingles/hcp/clinical-overview.html. Accessed July 18, 2018.
3. Fazio S. Postherpetic neuralgia [blog]. https://blogs.nejm.org/now/index.php/postherpetic-neuralgia/2014/10/17/. Accessed July 18, 2018.
4. Crawford C. ACIP recommends new herpes zoster subunit vaccine. http://www.aafp.org/news/health-of-the-public/20171031acipmeeting.html. Accessed July 18, 2018.
6. Lal H, Cunningham AL, Godeaux O, et al Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087–2096.
7. Dooling KL, Guo A, Patel M, et al Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3):103–108.
8. Cunningham AL, Lal H, Kovac M, et al Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019–1032.
9. Oxman MN, Levin MJ, Johnson GR, et al A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352(22):2271–2284.
10. Schmader KE, Oxman MN, Levin MJ, et al Persistence of the efficacy of zoster vaccine in the shingles prevention study and the short-term persistence substudy. Clin Infect Dis. 2012;55(10):1320–1328.
11. Morrison VA, Johnson GR, Schmader KE, et al Long-term persistence of zoster vaccine efficacy. Clin Infect Dis. 2015;60(6):900–909.
12. Bharucha T, Ming D, Breuer J. A critical appraisal of ‘Shingrix’, a novel herpes zoster subunit vaccine (HZ/su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017;13(8):1789–1797.
13. Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States 2018. http://www.cdc.gov/vaccines/schedules/hcp/adult.html. Accessed July 18, 2018.
14. Zostavax. http://online.lexi.com. Accessed May 22, 2018.
    15. Shingrix. http://online.lexi.com. Accessed May 22, 2018.
      Keywords:

      herpes zoster; shingles; postherpetic neuralgia; adjuvanted subunit vaccine; immunization; Shingrix

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