1. In this randomized controlled trial, autologous hematopoietic stem cell transplantation patients who received 2 recombinant zoster vaccine doses had reduced incidence of herpes zoster compared to placebo.
2. Injection site pain, myalgia, and fatigue were the most common adverse reactions to the vaccine.
Evidence Rating Level: 1 (Excellent)
Study Rundown: After autologous hematopoietic stem cell transplantation (HSCT), there is risk of herpes zoster due to diminished T-cell immunity within the first 2 to 3 years. Vaccination can provide long-term protection against herpes zoster, but the vaccine cannot be live attenuated, as they are contraindicated in immunocompromised patients. In this randomized controlled trial, HSCT patients who received 2 doses of recombinant, non-live zoster vaccine shortly after autologous HSCT exhibited reduced incidence of herpes zoster after a median follow-up of close to 2 years compared to placebo. Injection site pain, myalgia, and fatigue were the most common adverse reactions to the vaccine.
While this represents a promising prophylactic treatment for these patients, this study has several limitations. There was not enough power to compare incidences of herpes zoster–related complications excluding post-herpetic neuralgia, post-herpetic neuralgia, and hospitalizations. Further, the study was not long enough to assess effects beyond the second year.
In-Depth [randomized controlled trial]: The Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) trial recruited 1846 patients who had undergone autologous HSCT. Patients were randomized to receive 2 doses of vaccine or placebo. The median follow-up of 21 months started 1 month after dose 2. 184 confirmed herpes zoster cases occurred in the modified total vaccinated cohort (49 vaccine recipients and 135 placebo recipients). The overall incidences of herpes zoster were 30 and 94 per 1000 person years in the vaccine and placebo groups, respectively, and the incidence rate ratio (IRR) of first herpes zoster episode was 0.32 (CI95 0.22-0.44). With regards to secondary outcomes, the number of participants with herpes zoster–related complications was low. Solicited injection site reactions and general symptoms occurring within 7 days of vaccination were more frequent in vaccine recipients (90%) than in placebo recipients (53%). Pain was the most common injection site symptom, occurring in 84% of vaccine recipients.
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