By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved a second zoster vaccine for the prevention of shingles in adults. In contrast to the first vaccine (Zostavax), which is a live attenuated vaccine (ZVL), zoster vaccine recombinant adjuvanted is non-live and comprised of the surface glycoprotein E antigen component (HZ/su). This vaccine is marketed as Shingrix.
INDICATIONS
HZ/su is indicated for the prevention of herpes zoster (shingles) (HZ) in adults ≥ 50 years of age.1
DOSAGE
The recommended dose is 0.5 mL given intramuscularly at zero and two to six months.1 HZ/su is available as a single-dose vial of lyophilized varicella zoster virus glycoprotein E antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component.
POTENTIAL ADVANTAGES
HZ/su is more effective than ZVL in vaccine efficacy.
POTENTIAL DISADVANTAGES
HZ/su requires two injections, compared to a single dose for ZVL. There is potential for reduced adherence with the second dose.
COMMENTS
Efficacy was evaluated in two randomized, placebo-controlled, observer-blind clinical studies.1,2 Study 1 included subjects ≥ 50 years of age. Study 2 included subjects ≥ 70 years of age. In study 1, subjects were randomized to HZ/su or placebo and stratified by age: 50-59, 60-69, 70-79, and ≥ 80 years. The researchers excluded immunocompromised subjects, those with a history of previous herpes zoster, or those who were vaccinated against varicella or HZ. Subjects were followed for a median of 3.1 years. The primary endpoint was confirmed cases of HZ. In an analysis population of 14,759 subjects, HZ/su reduced the risk of developing HZ by 97.2%, with no clear differences among the age stratum. No cases of postherpetic neuralgia (PHN) were reported in the vaccine group, compared to 18 in the placebo group. Study 2 randomized subjects 70-79 and ≥ 80 years to HZ/su or placebo with a median follow-up of 3.9 years. In an analysis cohort of 13,163 subjects, vaccine efficacy was 89.8%. Pooled data from the two studies showed vaccine efficacy of 91.3% for those ≥ 70 years of age. There were four cases of PHN in the vaccine group vs. 36 in the placebo group. The efficacy of HZ/su is more effective than reported with ZVL. A review of three large retrospective, nested, case-control studies totaling approximately 2.4 million mainly immunocompetent subjects showed a real-world effectiveness of ZVL of 48-55% in reducing the incidence of HZ and 59-62% in reducing post-herpetic neuralgia.
In an open-label study, there was no interference reported between HZ/su and a quadrivalent influenza vaccine (Fluarix).1 In patients with a prior history of herpes zoster, HZ/su has been shown to induce immune response of 90% (95% confidence interval, 82-96%) based on anti-glycoprotein E antibodies one month after the second dose.5 In adults previously vaccinated with ZVL, immune response to HZ/su was noninferior to those previously not vaccinated.6 Most common adverse reactions associated with HZ/su are pain, redness, and swelling at the injection site. Others include muscle pain, tiredness, headache, shivering, fever, and upset stomach.1
CLINICAL IMPLICATIONS
Shingles is caused by the reactivation of dormant varicella zoster virus. Older individuals are at higher risk because of the reduced ability of the immune system to prevent activation. The disease usually occurs between ages 50-79 years, with an overall incidence of 2.0-4.6 cases per 1,000 person-years and increases to 10-12.8 per 1,000 person-years in those ≥ 80 years of age.2,7 Postherpetic neuralgia is a complication of shingles that occurs in 20% of cases in individuals between 60-65 years of age and approximately 30% in those > 80 years of age.7 HZ/su offers a more effective vaccine and is recommended by the Advisory Committee on Immunization Practices for the prevention of herpes zoster and related complications for immunocompetent adults ≥ 50 years of age, for adults who previously received Zostavax, and is preferred over Zostavax.8 The cost for Shingrix is $280 for two doses.
REFERENCES
- Shingrix Prescribing Information. GlaxoSmithKline Biologicals, October 2017.
- 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;375:1019-1032.
- Ansaldi F, Trucchi C, Alicino C, et al. Real-world effectiveness and safety of a live-attenuated herpes zoster vaccine: A comprehensive review. Adv Ther 2016;33:1094-1104.
- Zostavax Prescribing Information. Merck & Co., Inc, May 2017.
- Godeaux O, Kovac M, Shu D, et al. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother 2017;13:1051-1058.
- Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live-attenuated herpes zoster vaccine. J Infect Dis 2017 Sep 26. doi: 10.1093/infdis/jix482. [Epub ahead of print].
- Fashner J, Bell AL. Herpes zoster and postherpetic neuralgia: Prevention and management. Am Fam Physician 2011;83:1432-1437.
- American Academy of Family Physicians. ACIP Recommends New Herpes Zoster Subunit Vaccine, Oct. 31, 2017. Available at: http://bit.ly/2hIRPrb. Accessed Nov. 22, 2017.
Shingrix is indicated for the prevention of herpes zoster in adults ≥ 50 years of age.
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