Autologous hematopoietic stem-cell transplantation (HSCT) is used to treat various types of cancer, including multiple myeloma, leukemia, and some lymphomas.
One of the most common and painful side effects of cell therapy is the development of shingles, but now a study published in JAMA suggests that immunization with a newer form of shingles vaccine can reduce outbreaks of the painful rash.
Duke Health–led researchers used a nonlive form of the herpes zoster virus to test vaccination among patients whose immune systems are wiped out during HSCT. They pointed out that HSCT patients are especially likely to develop shingles, which is caused by reactivation of the latent varicella-zoster virus that also causes chicken pox.
“This trial is important because it demonstrates that the vaccine works in severely immunosuppressed patients,” explained oncologist Keith Sullivan, MD. “That suggests it could also work with others whose immune systems are not normal—including patients with HIV, breast cancer and auto-immune conditions.”
To assess the efficacy and adverse-event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients, the researchers conducted a phase III, randomized, observer-blinded study in 167 centers in 28 countries between July 13, 2012, and February 1, 2017. Participants were 1,846 adult patients who had undergone recent autologous HSCT.
About one-half of the participants were randomized to receive two doses of recombinant zoster vaccine, while the other half were administered a placebo. The first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. The study team was looking at the occurrence of confirmed herpes zoster cases.
During the 21-month median follow-up, at least one herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1,000 person-years, respectively), for an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P <.001).
At a median follow-up of 21 months, the vaccine group had 30 cases of shingles per 1,000 person-years compared with 94 cases per 1,000 person-years among patients receiving placebo injections, the authors pointed out, adding that the vaccine also apparently reduced the incidence of painful postherpetic neuralgia, shingles-related hospitalizations, and complications and duration of pain.
Of eight secondary end points, researchers reported that three showed significant reductions in the incidence of postherpetic neuralgia (vaccine, n = 1; placebo, n = 9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and other prespecified herpes zoster–related complications (vaccine, n = 3; placebo, n = 13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in the duration of severe worst herpes zoster–associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01).
Injection-site reactions, of which pain was the most common (occurring in 84% of vaccine recipients; grade 3: 11%), were documented in 86% of vaccine and 10% of placebo recipients. However, there was no difference identified in unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses between the two groups, the researchers said.
“Among adults who had undergone autologous HSCT, a two-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months,” the authors concluded.
“Among HSCT patients, a shingles outbreak is often more feared than the transplant itself, and I’ve had patients tell me they’d undergo two transplants before facing another episode of shingles,” Dr. Sullivan added. “It’s hugely gratifying, and a welcome surprise, to see such a strong immune response among this study population.”
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