Autor:innen:
Dr. Johannes Hain | GlaxoSmithKline GmbH & Co. KG | Germany
Lidia Oostvogels | GlaxoSmithKline | Belgium
Thomas Heinemann | GlaxoSmithKline | United States
Robert Johnson | University of Bristol | United Kingdom
Myron Levin | University of Colorado | United States
Dr. Janet McElhaney | Health Sciences North Research Institute | Canada
Peter Van den Steen | GlaxoSmithKline | Belgium
Toufik Zahaf | GlaxoSmithKline | Belgium
Alemnew Dagnew | GlaxoSmithKline | United States
Roman Chlibek | University of Defense | Czech Republic
Javier Diez Domingo | Fundación para el Fomento de la Investigación Sanitaria y Biomédica | Spain
Iris Gorfinkel | PrimeHealth Clinical Research | Canada
Caroline Herve | GlaxoSmithKline | Belgium
Shinn-Jang Hwang | Taipei Veterans General Hospital and National Yang Ming University School of Medicine | Taiwan
Hideyuki Ikematsu | Japan Physicians Association | Japan
George Kalema | Keyrus Biopharma c/o GSK | Belgium
Himal Lal | GlaxoSmithKline | United States
Shelly McNeil | IWK Health Center and Nova Scotia Health Authority | Canada
Tomas Mrkvan | GlaxoSmithKline | Belgium
Karlis Pauksens | Uppsala University Hospital | Sweden
Jan Smetana | University of Defense | Czech Republic
Daisuke Watanabe | Aichi Medical University | Japan
Lily Weckx | Federal University of Sao Paulo | Brazil
Anthony Cunningham | University of Sydney | Australia
Background:
The adjuvanted recombinant zoster vaccine (RZV) showed high vaccine efficacy (VE) against herpes zoster (HZ) in adults ≥50 and ≥70 years old (ZOE-50 and -70 trials, respectively). Participants who were immunocompromised or who were receiving immunosuppressive therapy were excluded from the ZOE-50 and -70 trials. Subjects with other medical conditions at baseline, including conditions known to be linked to a potential increased risk of HZ, were enrolled in these studies. The study population is a representative sample of the general adult population over the age of 50 years.
Methods:
A post-hoc analysis of the pooled ZOE-50 and -70 (ZOE-50/70) trials (NCT01165177; NCT01165229) assessed VE and safety in adults ≥50 years old reporting at least 1 medical condition at enrollment. The medical conditions included in the analysis were present at enrollment in ≥500 participants in both the placebo and the RZV recipients of the ZOE-50 and -70. These medical conditions included those that have been recognized to be associated with an increased risk of HZ (asthma, depression, respiratory disorders, and renal disorders). Fatal/serious adverse events (SAEs) were recorded for at least 12 months after the 2nd vaccination, potential immune-mediated diseases (pIMDs) were recorded during the entire study period and were assessed with consideration of subjects’ baseline medical conditions.
Results:
Of the 30,977 participants enrolled in the ZOE-50/70 studies, 13,881 RZV and 14,035 placebo recipients were included in the pooled cohort for this analysis. Of these, 82.3% of RZV recipients and 82.7% of placebo recipients had at least 1 of the 15 selected medical conditions at enrollment. A majority (RZV: 59.6%; Placebo: 59.8%) reported more than 1 condition. The most frequent baseline medical conditions in the study population were hypertension, osteoarthritis vertebral disorders, and dyslipidemia. VE ranged from 84.5% (95% confidence interval [CI]: 46.4–97.1) (respiratory disorders) to 97.0% (95% CI: 82.3–99.9) (coronary heart disease). Overall, RZV efficacy remained >90% irrespective of the number of medical conditions reported by a participant. Frequencies of SAEs, deaths, and pIMDs were balanced between the RZV and the placebo recipients.
Conclusions:
Medical conditions were common amongst participants in the ZOE-50/70 trials at enrolment and did not impact RZV vaccine efficacy or safety profile.
Funding: GlaxoSmithKline Biologicals SA