Reactogenicity of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults: Results of the Phase 3 ZOE-50 Trial
Year: 2015
Type: article
Abstract: Background. In the phase 3 ZOE-50 trial, the HZ/su investigational subunit vaccine, containing the varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, showed 97.2% vaccine efficacy for the prevention of herpes zoster in adults ≥50 years of age (Cunningham et al, 2015; N Engl J Med). Here, we present solicited injection site and systemic reactions to vaccinations in a sub-cohort of study participants. Methods. We conducted a randomized, observer-blind, placebo-controlled, multi-country, phase 3 trial in adults ≥50 years of age (stratified by age: 50–59, 60–69, and ≥70 years). Subjects were randomized 1:1 to receive 2 intramuscular doses of HZ/su or placebo (saline) 2 months apart. Solicited injection site and systemic reactions were recorded for 7 days after each vaccination by a subset of subjects (all subjects ≥70 years of age and randomly-selected subjects in the 50–59 and 60–69 years age strata). Reaction intensity was scored on a scale of 0-3. Results. Of the 15,411 evaluable subjects who received at least 1 dose of HZ/su or placebo, 8926 were assigned to the reactogenicity subset (HZ/su group, N = 4460; placebo group, N = 4466). Solicited reactions were more common in the HZ/su group than in the placebo group. Injection site reactions occurred in 81.5% of HZ/su and 11.9% of placebo recipients (grade 3 in 9.5% and 0.4%), and systemic reactions in 66.1% of HZ/su and 29.5% of placebo recipients (grade 3 in 11.4% and 2.4%). The most frequent reactions in the HZ/su group were injection site pain (HZ/su: 79.1%; placebo: 11.2%), myalgia (46.3% versus 12.1%), and fatigue (45.9% versus 16.6%). Median durations of the different solicited reactions were 1–3 days (Grade 3: 1-2 days; figure 1). The frequencies of reported solicited reactions decreased with increasing age both in HZ/su recipients (from 91.4% in subjects aged 50–59 years to 78.6% in those aged ≥70 years) and in placebo recipients (from 41.1% to 28.4%) (figure 2). Conclusion. The HZ/su vaccine was more reactogenic than placebo in the ZOE-50 study, with grade 3 reactions in up to 11.4% of HZ/su vaccine recipients. All reactions were transient and mostly of mild to moderate intensity. Reactogenicity decreased with increasing age (NCT01165177). Disclosures. T. Vesikari, GSK Vaccines: Grant Investigator, Research grant and Speaker honorarium. Merck: Grant Investigator, Research grant and Speaker honorarium SP MSD: Board Member, Consulting fee; A. L. Cunningham, GSK Vaccines: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Merck International: Scientific Advisor, Consulting fee. Bio CSL: Scientific Advisor, Consulting fee; O. Godeaux, GSK Vaccines: Employee and Shareholder, Salary; L. Campora, GSK Vaccines: Employee, Salary; R. Chlibek, GSK Vaccines: Grant Investigator, Consulting fee, Research grant and Speaker honorarium. Pfizer: Grant Investigator and Scientific Advisor, Consulting fee and Speaker honorarium; S. J. Hwang, GSK Vaccines: Grant Investigator, Research grant; M. Kovac, GSK Vaccines: Employee and Shareholder, Salary. M. Levin, GSK Vaccines: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Merck, Sharp & Dohme: Grant Investigator and Shareholder, Consulting fee, Licensing agreement or royalty and Research grant. J. Mcelhaney, GSK Vaccines: Grant Investigator, Research grant and Speaker honorarium Sanofi Pasteur: Speaker's Bureau, Speaker honorarium; S. A. Mcneil, GSK Vaccines: Grant Investigator, Research grant Pfizer: Grant Investigator, Research grant Sanofi Pasteur: Grant Investigator, Research grant; D. Watanabe, GSK Vaccines: Scientific Advisor, Consulting fee; W. Yeo, GSK Vaccines: Grant Investigator, Research grant; T. Zahaf, GSK Vaccines: Employee and Shareholder, Salary; H. Lal, GSK Vaccines: Employee and Shareholder, Salary; T. Heineman, GSK Vaccines: Employee and Shareholder, Salary.
Source: Open Forum Infectious Diseases
Authors: Timo Vesikari, Anthony L. Cunningham, Olivier Godeaux, Anitta Ahonen, Laura Campora, Roman Chlibek, Iris Gorfinkel, Shinn-Jang Hwang, Martina Kovac, Tiina Korhonen, Myron Levin, Janet Mcelhaney, Shelly A. Mcneil, Lars Rombo, Daisuke Watanabe, Wilfred Yeo, Toufik Zahaf, Himal Lal, Thomas Heineman
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
OpenAlex ID: W2259536094