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Clinical Trial
. 2023 Apr 1;164(4):741-748.
doi: 10.1097/j.pain.0000000000002760. Epub 2022 Aug 19.

Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials

Joon Hyung Kim  1 , Robert Johnson  2 , Martina Kovac  1 , Anthony L Cunningham  3   4 , Mohamed Amakrane  5 , Keith M Sullivan  6 , Alemnew F Dagnew  1 , Desmond Curran  5 , Anne Schuind  1
Affiliations
Clinical Trial

Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials

Joon Hyung Kim et al. Pain. .

Abstract

Herpes zoster (HZ) and HZ-associated pain greatly affect patients' quality of life, particularly in older and immunocompromised adults, for whom comorbidities and polypharmacy are often reported. Three phase III, randomized, placebo-controlled clinical trials have reported the adjuvanted recombinant zoster vaccine (RZV) as highly efficacious in preventing HZ and reducing pain severity in healthy adults ≥50 years old (Zoster Efficacy Study [ZOE]-50 study, NCT01165177) and ≥70 years old (ZOE-70; NCT01165229) and in immunocompromised adults ≥18 years old undergoing autologous hematopoietic stem cell transplantation (ZOE-HSCT; NCT01610414). Here, we investigated efficacy of RZV in reducing (i) the duration of clinically significant pain (Zoster Brief Pain Inventory pain score ≥3) and (ii) HZ-associated pain medication use and duration of use in participants with confirmed HZ ("breakthrough cases") from the 3 studies. Recombinant zoster vaccine effectively reduced the duration of clinically significant HZ-associated pain during HZ episodes by 38.5% ( P -value: 0.010) in the ZOE-HSCT study. Although a similar trend was observed in the ZOE-50 and ZOE-70 studies, the results were not statistically significant because of the high vaccine efficacy (VE) against HZ resulting in rare breakthrough cases. VE in reducing pain medication use (39.6%; P -value: 0.008) and duration of medication use (49.3%, P -value: 0.040) was reported in the ZOE-70 study; corresponding positive VE estimates were observed in the ZOE-50 and ZOE-HSCT studies but were not statistically significant. Data reported here demonstrate efficacy of RZV in reducing HZ-associated pain duration and pain medication use in breakthrough cases, thereby improving quality of life of those with HZ.

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Conflict of interest statement

D.C., A.F.D., J.H.K., M.K., and A.S. were employees of the GSK group of companies at the time the studies were designed, initiated, and/or conducted. A.F.D., M.K., and A.S. are currently employees of the Bill & Melinda Gates Medical Research Institute, PPD, and PATH, respectively. M.A. is an employee of Akka Technologies c/o GSK. D.C., A.F.D., J.H.K., A.S., and M.K. hold or held shares/stock options in GSK group of companies as part of their remuneration. A.L.C. received honorary payment to his institution from GSK group of companies BioCSL/Seqirus and Merck outside the submitted work. R.J. reports personal and consulting fees from GSK group of companies both during the conduct of the study and outside the submitted work and research grant from NIHR. K.M.S. reports grant and/or consulting fees from NIAID-NIH, Roche Genentech, Magenta, Kiadis, GSK group of companies, Jasper, Talaris, and Xenikos; honoraria for lecture from Vanderbilt University, Emory University, EBMT, Washington University in St Louis; lecture support from EBMT, Emory University, Magenta, Washington University in St Louis outside the submitted work. Authors have no other financial and nonfinancial interests to declare.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Figures

Figure 1.
Figure 1.
Plain language summary.
See this image and copyright information in PMC

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