• Pain · Apr 2023

    Randomized Controlled Trial

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

    • Joon Hyung Kim, Robert Johnson, Martina Kovac, Anthony L Cunningham, Mohamed Amakrane, Keith M Sullivan, Alemnew F Dagnew, Desmond Curran, and Anne Schuind.
    • GSK, Rockville, MD, United States , Martina Kovac is now with the PPD, Bethesda, MD, United States. Alemnew F. Dagnew is now with the Bill & Melinda Gates Medical Research Institute, Cambridge, MA, United States. Anne Schuind is now with the PATH, Washington, DC, United States.
    • Pain. 2023 Apr 1; 164 (4): 741748741-748.

    AbstractHerpes 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.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.

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