Investigational herpes zoster vaccine is safe, effective in older adults with prior infection

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Takeaway

  • An adjuvanted recombinant subunit herpes zoster vaccine (Hz/su) was found safe and immunogenic in adults aged ≥50 y with a prior history of herpes zoster infection documented by a physician.

Why this matters

  • The patient population, older adults with prior history of herpes zoster infection, had been excluded from prior clinical trials.

Study design

  • This was a phase 3, nonrandomized, open-label, multicenter trial of 96 older adults administered 2 doses of HZ/su 2 mo apart and followed for another 12 mo.
  • Immunogenicity was assessed by anti-glycoprotein E (gE) antibodies using ELISA.
  • The primary immunogenicity outcome was met "if the lower limit of the 95% CI of the vaccine response rate (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was ≥60%."
  • Funding: GlaxoSmithKline.

Key results

  • The primary immunogenicity outcome was fulfilled, with the VRR at month 3 being 90.2%.
  • 77.9% of participants reported local solicited adverse events (AEs); 71.6% reported general solicited AEs.
  • The most common solicited AEs were pain at the injection site, fatigue, headache, myalgia, and shivering.

Limitations

  • Nonrandomized, open-label design.