New Shingles Vaccine Is Safe, Effective

The herpes zoster recombinant subunit vaccine (HZ/su) has demonstrated consistent safety and immunogenicity across various manufacturing lots, according to a recent study.

The risk for HZ increases with age, and previous evidence has shown that the adjuvanted varicella-zoster virus (VZV) glycoprogein E (gE) recombinant subunit vaccine is more than 90% effective in preventing HZ in adults age 50 years and older.
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In their phase III, randomized study, the researchers assessed 651 participants who had received the HZ/su vaccine, as well as lot-to-lot consistency in the immunogenicity and safety of several HZ/su manufacturing lots. A total of 638 participants had received both doses of the vaccine, and 634 had completed the study.

Humoral immunogenicity was evaluated prior to vaccination and at 1 month following the second vaccination. Lot-to-lot consistency was present if the 2-sided 95% confidence intervals of the anti-gE geometric mean ratio between all lot pairs were within 0.67 and 1.5.

Solicited symptoms were recorded within 7 days following each vaccination, and unsolicited adverse events were recorded within 30 days. Serious adverse events and potential immune-mediated diseases were reported until the end of the study (12 months following the second vaccination).

Results of the study indicated that humoral responses had been robust, and consistency had been demonstrated across 3 HZ/su manufacturing lots. The incidence of solicited symptoms, unsolicited adverse events, and serious adverse events had been similar in each lot. Two of 8 reported potential immune-mediated diseases were considered related to the study vaccine.

“The three HZ/su manufacturing lots demonstrated consistent immunogenicity,” the researchers concluded. “No safety concerns were identified.”

—Christina Vogt

Reference:

Strezova A, Godeaux O, Aggarwal N, et al. A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine. 2017;35(48):6700-6706. https://doi.org/10.1016/j.vaccine.2017.10.017.