FDA licensure of Shingrix for the new indication was based on the results of two studies: a randomized, placebo-controlled trial in 1846 immunocompromised adults ≥18 years old who had received an autologous hematopoietic stem cell transplant within the previous 50-70 days, and a post-hoc analysis of a similar trial in 569 adults who were receiving immunosuppressive therapy for hematologic malignancies. In both trials, Shingrix significantly decreased the incidence of herpes zoster occurring ≥1 month after the second dose compared to placebo (see Table 1).2,3

Adverse effects of Shingrix in immunocompromised persons appear to be similar to those in healthy older adults. Myalgia, fatigue, headache, shivering, fever, GI symptoms, and injection-site pain, redness, and swelling are common. Severe local reactions preventing normal daily activities can occur.1,4 In a postmarketing observa-tional study in adults ≥65 years old, use of Shingrix was associated with an increased risk of Guillain-Barré syndrome in the 6 weeks after vaccination.5

In healthy older adults, Shingrix is typically given as two 0.5-mL doses administered intramuscularly 2-6 months apart. For immunocompromised patients who would benefit from a shorter vaccination schedule, the second dose can be given as early as 1 month after the first. Updated recommendations from the Advisory Committee on Immunization Practices (ACIP) on use of the vaccine in immunocompromised persons were not available at press time.