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英格兰 HPV16/18-AS04 疫苗高覆盖率接种后的实施后监测如何为其交叉保护效果提供更多证据?

How has post-implementation surveillance of high-coverage vaccination with HPV16/18-AS04 vaccine in England added to evidence about its cross-protective effects?

机构信息

GSK, Tres Cantos, Spain.

UK Health Security Agency, London, United Kingdom.

出版信息

Vaccine. 2024 Oct 24;42(24):126215. doi: 10.1016/j.vaccine.2024.126215. Epub 2024 Aug 29.

Abstract

BACKGROUND

Bivalent human papillomavirus HPV16/18-AS04 vaccine (Cervarix, GSK) offers direct protection against HPV16/18. Results from randomised controlled trials showed cross protective effects and suggested that declines in some closely related HPV types could be expected in a population with high vaccination coverage.

AIM

To evaluate the evidence for cross-protection afforded by HPV16/18-AS04 from post-implementation surveillance in England, and how this complements clinical trial data and post-implementation observations in other countries.

METHODS

Evidence of cross-protection in young women offered vaccination with HPV16/18-AS04 was gathered from HPV surveillance in England. Data from clinical trials and other post-implementation studies were reviewed.

RESULTS

Surveillance using anonymised residual specimens in England found declines of 52.3%, 67.4% and 33.3% against grouped HPV-31/33/45 in 16-18, 19-21, and 22-24 year olds, respectively. Additionally, type-specific analysis found that the prevalence of HPV31 declined to below 1% across all age groups. Cross-protection has been monitored and maintained for over 10 years since the introduction of the vaccination programme. Cross-protection against HPV6/11 was not found in English surveillance outcomes.

CONCLUSION

Surveillance of type-specific infections in vaccine-eligible populations in England has generated clear evidence of cross-protective effects from HPV16/18-AS04 vaccination against high-risk HPV 31/33/45 infections, consistent with other post-implementation observations and confirming and in some ways exceeding expectations from clinical trials.

摘要

背景

二价人乳头瘤病毒(HPV)16/18 型 AS04 疫苗(佳达修,葛兰素史克)可直接预防 HPV16/18 型感染。随机对照试验的结果显示了交叉保护作用,并提示在高疫苗接种覆盖率人群中,预计一些密切相关的 HPV 型别的流行率将会下降。

目的

评估 HPV16/18-AS04 疫苗在英国实施后监测中提供的交叉保护证据,以及这如何补充临床试验数据和其他国家实施后的观察结果。

方法

从英国 HPV 监测中收集了 HPV16/18-AS04 疫苗接种后年轻女性交叉保护的证据。综述了临床试验和其他实施后研究的数据。

结果

英国使用匿名剩余标本进行的监测发现,16-18 岁、19-21 岁和 22-24 岁年龄组人群中 HPV-31/33/45 型别聚集组的感染下降了 52.3%、67.4%和 33.3%。此外,针对特定型别的分析发现,HPV31 型在所有年龄组的流行率均降至 1%以下。自疫苗接种计划推出以来,已对交叉保护进行了超过 10 年的监测和维护。在英国的监测结果中未发现 HPV6/11 型的交叉保护作用。

结论

对英格兰疫苗可及人群中特定型别感染的监测提供了明确证据,表明 HPV16/18-AS04 疫苗接种可对高危 HPV 31/33/45 型感染提供交叉保护作用,这与其他实施后观察结果一致,并在某些方面证实并超出了临床试验的预期。

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