Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: A randomised non-inferiority clinical trial

• DOI: 10.1016/j.vaccine.2014.12.024
• Publication Date: 2014-12-30T15:47:10Z
• Authors: Javier Diez-Domingo; Thomas Weinke; Juan Garcia de Lomas; Claudius U. Meyer; Isabelle Bertrand; Cécile Eymin; Stéphane Thomas; Christine Sadorge
• Keywords: ELISPOT; Varicella zoster virus

Zostavax(®) is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During clinical development Zostavax, which was mainly US, administrated by subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines intramuscular (IM) This an open-label, randomised trial conducted 354 subjects The primary objectives were to demonstrate that IM administration both non-inferior SC terms 4-week post-vaccination geometric mean titres (GMTs), elicits acceptable fold-rise (GMFR) antibody measured glycoprotein enzyme-linked immunosorbent assay. Pre-specified non-inferiority set as lower bound 95% confidence interval (CI) GMT ratio (IM/SC) being >0.67. An GMFR route pre-specified its CI >1.4. Description VZV immune response using interferon-gamma immunospot (IFN-γ ELISPOT) assay safety secondary objectives. Participants or (1:1). baseline demographics comparable between groups; age: 62.6 years (range: 50.0-90.5). immunogenicity met (per protocol analysis): (IM/SC): 1.05 (95% CI: 0.93-1.18); GMFR: 2.7 (2.4-3.0). IFN-γ ELISPOT groups. Frequencies systemic adverse events Injection-site reactions less frequent with than route: erythema (15.9% versus 52.5%), pain (25.6% 39.5%) swelling (13.6% 37.3%), respectively. adults years, Zostavax elicited similar responses well tolerated, fewer injection-site administration.