Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial

Abstract

This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documented history of HZ. Participants (stratified by age: 50–59, 60–69 and ≥ 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3). Solicited local and general adverse events (AEs) were recorded for 7 d and unsolicited AEs for 30 d after each vaccination. Serious AEs were recorded until study end. The primary immunogenicity objective was met if the lower limit of the 95% confidence interval (CI) of the vaccine response rate (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was ≥ 60%. 96 participants (32/age group) were enrolled. The primary immunogenicity objective was met, as the VRR at Month 3 was 90.2% (95% CI: 81.7–95.7). Geometric mean anti-gE antibody concentrations at Month 3 were similar across age groups. 77.9% and 71.6% of participants reported local and general solicited AEs, respectively. The most frequent solicited AEs were pain at injection site, fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in adults aged ≥ 50 y with a physician-documented history of HZ, and no safety concerns were identified.

Herpes Zoster in the Older Adult

“…The subunit vaccine is also immunogenic and safe in people that have had a previous episode of HZ. 67 …”

Vaccination practices in dialysis patients: A narrative review

“…In another study, a group of patients with a history of herpes zoster infections showed a very good production of IgE antibodies with RZV. The study concluded that vaccine reactogenicity and safety are not impacted by a prior history HZ infection . There have been no studies yet with dialysis patients or patients with CKD.…”

“…In the countries where it is currently available, RZV in 2 doses between 2‐6 months apart is recommended in all susceptible patients …”

Mögen auch die Viren süßes Blut am liebsten?

“…Die Immunogenität und Sicherheit einer HZ/su-Impfung bei ≥ 50-jährigen Patienten nach einer vorausgegangenen HZ-Erkrankung wurde in einer nicht-randomisierten, offenen Multicenterstudie in Kanada und Russland zwischen Juni 2013 und November 2014 untersucht. 24 Von den Teilneh-merInnen der Studie (n = 96) waren 68 % (n = 65) innerhalb der vergangenen 4 Jahre an einem HZ erkrankt, keiner von ihnen wies jedoch aktive HZ-Krankheitszeichen auf. Bei 19 % (n = 18) lag die HZ-Episode 5 -9 Jahre zurück und bei 14 % (n = 13) war der HZ vor ≥ 10 Jahren aufgetreten.…”