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肌肉注射的带状疱疹亚单位疫苗对Sprague-Dawley大鼠的生育能力、产前和产后发育没有影响。

Intramuscularly administered herpes zoster subunit vaccine has no effects on fertility, pre- and post-natal development in Sprague-Dawley rats.

作者信息

Segal Lawrence, Thacker Karen, Fochesato Michel, Giordano Giulia, Garçon Nathalie, Destexhe Eric

机构信息

GSK Vaccines, Rixensart, Belgium.

Envigo CRS Limited (formerly Huntingdon Life Sciences), Huntingdon, Cambridgeshire, United Kingdom.

出版信息

Reprod Toxicol. 2017 Apr;69:297-307. doi: 10.1016/j.reprotox.2017.03.015. Epub 2017 Mar 31.

DOI:10.1016/j.reprotox.2017.03.015
PMID:28366586
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.

摘要

带状疱疹亚单位疫苗(HZ/su)是一种用于预防带状疱疹的研究性疫苗,带状疱疹是由水痘-带状疱疹病毒(VZV)引起的疾病。它由重组VZV糖蛋白E(gE)和AS01组成。我们评估了gE/AS01和单独的AS01对Sprague-Dawley大鼠的雌性和雄性生育能力以及胚胎-胎儿、产前和产后发育的潜在毒性作用。雌性大鼠在配对前和妊娠期进行免疫。一半的怀孕大鼠用于胚胎-胎儿研究。分娩的大鼠在哺乳期进行免疫,并对后代进行分析。在一项雄性生育力研究中,大鼠在配对前进行免疫。交配后,处死未处理的雌性大鼠并检查胎儿。此外,还评估了雄性生育参数。结果表明,肌肉注射带状疱疹候选疫苗gE/AS01对雌性的交配性能和生育力、产前和产后存活率以及后代发育、雄性的交配性能和生育力均无影响。

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