- 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.
- 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.
- 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.
- Nonrandomized, open-label design.