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Abstract
The impact of alternate routes of vaccine administration, subcutaneous (SC) or intramuscular (IM), on the safety and immunogenicity of herpes zoster subunit candidate vaccine (HZ/su) was assessed in Japanese adults aged ≥ 50 y. During this phase III open-label study, 60 subjects were randomized (1:1) to receive HZ/su through SC or IM routes in a 0, 2 month schedule. Vaccine response rates (VRRs) and geometric mean concentrations (GMCs) of varicella zoster virus glycoprotein E (gE)-specific antibodies were determined by ELISA. Solicited and unsolicited symptoms were recorded for 7 and 30 d after each vaccination and graded 1–3 in severity. Serious adverse events (SAEs) were recorded throughout the study. At one month post-dose 2, VRRs were 100% (95% Confidence Interval (CI): 88.1–100) in both groups; anti-gE antibody GMCs were 44126.1 mIU/ml (95% CI: 36326.1–53601.0) and 45521.5 mIU/ml (95% CI; 37549.5–55185.9) in the SC and IM groups, respectively. Injection site reactions (pain, swelling and redness) were common, and observed more frequently following SC administration. Grade 3 redness and swelling were more frequently observed after SC administration. Fatigue and headache were the most frequently reported general symptoms for both routes of administration. Ten and 7 unsolicited AEs were reported in the SC and IM group, respectively. Two unsolicited AEs (1 in SC; 1 in IM) were considered related to vaccination by the investigator. Three non-fatal SAEs considered unrelated to vaccination were reported during the study. Administration of the HZ/su vaccine candidate resulted in a substantial immune response that was comparable between SC and IM subjects, but local reactogenicity may be greater for SC.
Abbreviations
| AEs | = | Adverse events |
| CI | = | Confidence interval |
| gE | = | Varicella zoster virus glycoprotein E |
| GMCs | = | Geometric mean concentrations |
| HZ | = | Herpes zoster |
| HZ/su | = | Herpes zoster subunit vaccine |
| IM | = | Intramuscular |
| MGI | = | Mean geometric increase |
| SAEs | = | Serious adverse events |
| SC | = | Subcutaneous |
| SRC | = | Safety review committee |
| VRRs | = | Vaccine response rates |
| VZV | = | Varicella zoster virus |
| YOA | = | Years of age |
Disclosure of potential conflicts of interest
Peter Vink and Martine Douha are employees of the GlaxoSmithKline group of companies and, as such, are compensated by GSK for work both related and unrelated to the submitted work. Peter Vink receives GSK stock equity as part of his compensation. Himal Lal and Thomas Heineman were employees of GSK and received salary and stock as compensation at the time of the study design, conduct, and interpretation of data and writing of manuscript. Himal Lal is currently an employee of Pfizer. Thomas Heineman is currently an employee of Genocea Biosciences. Masayuki Ogawa and Masahiro Eda are employees of the Japan Vaccine Company. Masanari Shiramoto declares having no potential conflicts of interest.
Acknowledgments
We thank study participants and staff at SOUSEKAI PS Clinic, Japan. We thank An Ranquin and Katherine Ward for writing the study reports for this study. Editorial assistance and coordination in the preparation of this manuscript was provided by Dr. Jarno Jansen and Dr. Bart van Heertum (XPE Pharma for GSK Vaccines). Writing assistance was provided by Dr. Sasi Taneja and Prachee Panda (GSK).
Funding
This study was sponsored and funded by GlaxoSmithKline Biologicals S.A., Rixensart, Belgium and Japan Vaccine Company, Tokyo, Japan. GlaxoSmithKline Biologicals SA was involved in all stages of the study conduct and analysis; and also took charge of all costs associated with the development and the publishing of the manuscript.
Clinical Trial Registration: www.clinicaltrials.gov, NCT01777321