A 2-dose course of recombinant zoster vaccine (Shingrix, GlaxoSmithKline) decreased the incidence of herpes zoster in adults who had undergone recent autologous hematopoietic stem cell transplantation (HSCT) during a median follow-up of 21 months, according to study results published in JAMA.

In this phase 3, observer-blinded study (ClinicalTrials.gov identifier: NCT01610414) conducted in 167 centers in 28 countries, participants aged >18 years who had undergone recent autologous HSCT were randomly assigned in a 1:1 ratio to receive either recombinant zoster vaccine or placebo. Participants received two 0.5-mL doses of either recombinant zoster vaccine or placebo administered intramuscularly to the deltoid muscle. The first dose was given 50 to 70 days after transplantation, and the second dose 1 to 2 months thereafter. The primary end point was occurrence of confirmed herpes zoster cases.

Of the 1846 participants included in the study who received 1 vaccine or placebo dose, 1735 received a second dose (873 in the vaccine group; 862 in the placebo group), and 1366 completed the study (694 in the vaccine group; 672 in the placebo group). Participants included in the study were mostly men (63%) and aged > 50 years (75%). The most common underlying diagnosis was multiple myeloma (53%).

In the modified total vaccinated cohort, which included 1721 participants who received 2 doses of the same investigational product (870/922 in the vaccine group and 851/924 in the placebo group), there were 184 confirmed herpes zoster cases during a median follow-up of 21 months (49 cases in vaccine recipients and 135 cases in placebo recipients). The overall incidence was 30 and 94 per 1000 person-years, respectively (incidence rate ratio [IRR], 0.32; 95% CI, 0.22-0.44; P <.001), equivalent to 68.2% vaccine efficacy.

Further, in the modified total vaccinated cohort, secondary and tertiary end points examining herpes zoster-related complications showed lower rates of complications in the vaccine group vs the placebo group:

  • Lower incidence of herpes zoster-related complications excluding postherpetic neuralgia (1.6 vs 7.1 cases per 1000 person-years) with an IRR of 0.22 (95% CI, 0.04-0.81; P =.02).
  • Lower incidence for postherpetic neuralgia (0.5 vs 4.9 cases per 1000 person-years) with an IRR of 0.11 (95% CI, 0.00-0.78; P =.02).
  • Lower rate of hospitalizations (1.1 vs 7.1 cases per 1000 person-years) with a hazard ratio of 0.15 (95% CI, 0.03-0.68; P =.01).
  • Reduced duration of worst herpes zoster-associated pain during disease episodes (892 vs 6275 days) with a hazard ratio of 0.62 (95% CI, 0.42-0.89; P =.01).

In terms of adverse events, injection site reactions were noted in 86% of participants in the vaccine group and 10% in the placebo group. Pain was the most common, occurring in 84% of vaccine recipients, with 11% reporting grade 3 pain. Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all points.

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“The recombinant zoster vaccine induced strong humoral and cellular immune responses, which were significantly higher than in the placebo group, consistent with previous observations,” noted the researchers.

Disclosure: This study was sponsored and funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline was also involved in the design and conduct of the study. Several authors disclosed being employees of and/or having relevant relationships with GlaxoSmithKline.

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Reference

Bastidas A, de la Serna J, El Idrissi M, et al; ZOE-HSCT Study Group Collaborators. Effect of recombinant zoster vaccine on incidence of herpes zoster after autologous stem cell transplantation: a randomized clinical trial. JAMA. 2019;322(2):123-133.

This article originally appeared on Infectious Disease Advisor