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Evaluation of the intramuscular administration of Cervarix vaccine on fertility, pre- and post-natal development in rats.

机译:肌肉注射Cervarix疫苗对大鼠生育力,产前和产后发育的评估。

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摘要

Cervarix is a prophylactic human papillomavirus (HPV)-16/18 vaccine for the prevention of cervical cancer. It contains GSK Biologicals' proprietary Adjuvant System AS04. The objective of this study was to investigate the effects of Cervarix and of AS04 on female fertility and pre- and post-natal development in Sprague Dawley rats. Female rats were injected with vaccine, AS04, or saline 30 days before mating and on Gestation Days 6, 8, 11 and 15. Each dose of vaccine was one-fifth the human dose volume. Treatment of rats with vaccine or AS04 was not associated with any systemic toxicity and had no impact on female fertility. There were no adverse effects on pre- or post-natal development of litters from treated rats, as judged by fetal evaluation at Gestation Day 20, and growth and survival of pups to postnatal Day 25. These results support the use of the vaccine in the targeted human population.
机译:Cervarix是一种预防性人乳头瘤病毒(HPV)-16/18疫苗,用于预防宫颈癌。它包含GSK Biologicals专有的佐剂系统AS04。这项研究的目的是研究Cervarix和AS04对Sprague Dawley大鼠雌性生育能力以及产前和产后发育的影响。雌性大鼠在交配前30天以及在妊娠第6、8、11和15天注射了疫苗,AS04或生理盐水。每剂疫苗的剂量是人体剂量的五分之一。用疫苗或AS04处理大鼠与任何全身毒性无关,并且对女性生育力没有影响。根据妊娠第20天的胎儿评估判断,以及对幼仔到出生后第25天的生长,存活的仔猪对产前或产后幼仔的发育都没有不利影响。这些结果支持了在产后25天使用疫苗。目标人群。

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