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

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.

Updated Public Health Impact and Cost Effectiveness of Recombinant Zoster Vaccine in Canadian Adults Aged 50 Years and Older

“…However, estimating the QALYs lost for HZ and PHN is challenging, as evidenced by the rather different values used in the analysis by McGirr et al [ 14 ] and the current study, which used newer values [ 41 ]. Moreover, the QALYs lost per case of HZ and PHN were assumed to be the same among vaccinated and unvaccinated individuals, but breakthrough HZ tends to be shorter [ 59 ]. Thus, the ICERs may have been overestimated.…”

Healthy ageing: Herpes zoster infection and the role of zoster vaccination

“…Data from the ZOE-70 study indicated that RZV significantly reduced HZ-associated pain medication use and duration of pain medication use in participants with confirmed HZ 73 . Figure 2 presents the distribution of the individual maximal ZBPI “worst-pain” scores experienced over the entire HZ episode for the ZOE-50 study 33 .…”

Exploring the Link between Varicella-Zoster Virus, Autoimmune Diseases, and the Role of Recombinant Zoster Vaccine

“…This sustained immune response is anticipated to remain as strong as the initial immune response above baseline for up to 15 years post-vaccination [142,144]. Moreover, RZV reduces the duration of HZ-associated pain and enhances patient quality of life by reducing the need for analgesics, even in breakthrough cases [145]. Thus, RZV vaccination not only reduces the incidence of HZ but also its complications and the utilization of medical resources, potentially leading to a considerable reduction in the public health burden [146].…”