Abstract

Clinical trial data and real-world evidence suggest that the AS04-adjuvanted vaccine targeting human papillomavirus types 16 and 18 (AS04-HPV-16/18) vaccine provides nearly 90% protection against cervical intraepithelial neoplasia grade 3 or higher irrespective of type, among women vaccinated before sexual debut. This high efficacy is not fully explained by cross-protection. Although AS04-HPV-16/18 vaccination does not affect clearance of prevalent infections, it may accelerate clearance of newly acquired infections. We pooled data from 2 large-scale randomized controlled trials to evaluate efficacy of the AS04-HPV-16/18 vaccine against clearance of nontargeted incident infections. Results of our analysis do not suggest an effect in expediting clearance of incident infections.

中文翻译：

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AS04 佐剂疫苗对抗人乳头瘤病毒 (HPV) 16 型和 18 型在清除事件 HPV 感染中的功效：哥斯达黎加疫苗试验和 PATRICIA 研究数据的汇总分析

摘要

临床试验数据和真实世界证据表明，针对 16 型和 18 型人乳头瘤病毒 (AS04-HPV-16/18) 疫苗的 AS04 佐剂疫苗可提供近 90% 的针对宫颈上皮内瘤变 3 级或更高级别的保护，无论其类型如何，在女性在首次性行为前接种疫苗。交叉保护不能完全解释这种高功效。虽然 AS04-HPV-16/18 疫苗接种不会影响流行感染的清除，但它可能会加速新获得性感染的清除。我们汇总了来自 2 项大规模随机对照试验的数据，以评估 AS04-HPV-16/18 疫苗对清除非靶向事件感染的功效。我们的分析结果并未表明在加速清除事件感染方面有效果。