What is the efficacy of the Shingrix vaccine in the prevention of herpes zoster (shingles)?

Updated: Jan 25, 2019
  • Author: Camila K Janniger, MD; Chief Editor: Dirk M Elston, MD  more...
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Answer

In October 2017, the FDA approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in adults aged 50 years and older. Approval is based on findings from a phase III clinical trial program assessing its efficacy, safety, and immunogenicity in 38,000 patients. Data from a pooled analysis of two clinical trials demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years. [9, 10]

The first trial, ZOE-50, was a randomized, placebo-controlled study conducted in 18 countries in Europe, North America, Latin America, and Asia-Australia. The study evaluated the efficacy, immunogenicity, and safety of the HZ/su vaccine in adults aged 50 years or older. Participants were randomly assigned in a 1:1 ratio to receive either HZ/su vaccine (0.5 mL at month 0 and 2) or placebo. Two doses of HZ/su administered 2 months apart had a vaccine efficacy of 97.2%, compared with placebo, in reducing the risk of herpes zoster in adults aged 50 years or older. The vaccine efficacy was similar among the three age groups. [9]

The second trial, ZOE-70, studied the safety and efficacy of HZ/su in adults aged 70 years or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster was 89.8% and was similar in participants aged 70-79 years (90.0%) and participants aged 80 years or older (89.1%). In pooled analyses of data from participants aged 70 years or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% and vaccine efficacy against postherpetic neuralgia was 88.8%. [10]

Thus, there are two vaccines: the zoster vaccine live (ZVL) and the more recent nonlive adjuvanted recombinant zoster vaccine (RZV). [132] ZVL efficacy may necessitate additional vaccination. Vaccination with RZV in immunocompetent adults aged 50 years or older is recommended, including those previously vaccinated with ZVL. The cost-effectiveness of vaccinating US adults aged 60 years and older, previously vaccinated with ZVL, was evaluated. Compared with revaccinating with ZVL, vaccination with RZV is highly desirable.


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