title: Intramuscularly administered herpes zoster subunit vaccine has no effects on fertility, pre- and post-natal development in Sprague-Dawley rats.
abstract: The herpes zoster subunit vaccine (HZ/su) is an investigational vaccine for the prevention of shingles, a disease caused by the varicella zoster virus (VZV). It is composed of recombinant VZV glycoprotein E (gE) and AS01. We assessed the potential toxic effects of gE/AS01 and AS01 alone on female and male fertility, and on embryo-fetal, pre- and post-natal development in Sprague-Dawley rats. Females were immunized before pairing and during gestation. Half of the pregnant rats were used for embryo-fetal investigations. The ones that gave birth were immunized during lactation and offspring were analysed. In a male fertility study, rats were immunized before pairing. After mating, the untreated females were sacrificed and the fetuses examined. In addition, male fertility parameters were evaluated. Results indicated that female mating performance and fertility, pre- and post-natal survival and offspring development, male mating performance and fertility were unaffected by intramuscular administration of the zoster candidate vaccine gE/AS01.
authors.affiliation: GSK Vaccines, Rixensart, Belgium.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Segal
authors.affiliation: Envigo CRS Limited (formerly Huntingdon Life Sciences), Huntingdon, Cambridgeshire, United Kingdom.
authors.forename: Karen
authors.initials: K
authors.lastname: Thacker
authors.affiliation: GSK Vaccines, Rixensart, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: Fochesato
authors.affiliation: GSK Vaccines, Rixensart, Belgium.
authors.forename: Giulia
authors.initials: G
authors.lastname: Giordano
authors.affiliation: GSK Vaccines, Rixensart, Belgium.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Garçon
authors.affiliation: GSK Vaccines, Rixensart, Belgium. Electronic address: eric.x.destexhe@gsk.com.
authors.forename: Eric
authors.initials: E
authors.lastname: Destexhe
mesh_terms: D000818:Animals; D047108:Embryonic Development / Q000187:drug effects; D005260:Female; D005298:Fertility / Q000187:drug effects; D047109:Fetal Development / Q000187:drug effects; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D007774:Lactation; D008297:Male; D011247:Pregnancy; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects; D022223:Vaccines, Subunit / Q000008:administration & dosage*
chemical_list: D053061:Herpes Zoster Vaccine; D022223:Vaccines, Subunit
keywords: AS01; Rat; Reproductive toxicology; Vaccine; Zoster