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.
“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.
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.