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

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

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

Adoración Navarro-Torné et al. Vaccine. .
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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.

Keywords: Cross-protection; Effectiveness; Efficacy; England; HPV16/18-AS04; Human papillomavirus; Surveillance.

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Conflict of interest statement

Declaration of competing interest ANT, VW and EG are employed by GSK. ANT may hold shares. sVW and EG hold shares in GSK. BB was a former GSK employee and he may hold company shares. VW is listed as inventor of patented unrelated vaccines. These authors declare no other financial and non-financial relationships and activities. The Blood Safety, Hepatitis, Sexually Transmitted Infections (STI) and HIV Service at UKHSA has provided GSK with post-marketing surveillance reports on HPV infections; a cost recovery charge is made for these reports. All other authors have no further conflict of interests. Funding statement: GlaxoSmithKline Biologicals SA took in charge all costs associated with the development and publishing of this manuscript.

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