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Impact of HPV16/18 vaccine on HPV genotype infection and cervical precancerous lesions: an implication for cervical cancer screening strategy
Proposal
5515
Title of Proposed Research
Impact of HPV16/18 vaccine on HPV genotype infection and cervical precancerous lesions: an implication for cervical cancer screening strategy
Lead Researcher
Fanghui Zhao
Affiliation
National Cancer Center & Cancer Hospital, Chinese Academy of Medical Sciences
Funding Source
None
Potential Conflicts of Interest
Professor Zhao was CO-PI of the project GSK-107638. Shangying Hu was an investigator in charge of study coordination and data management generated in the center lab in the project GSK-107638.
Data Sharing Agreement Date
26 June 2018
Lay Summary
HPV vaccination will lead to the change of HPV genotype infection, the reduction of cervical precancerous cases and decrease of proportion of lesions attributable to HPV16/18. It is estimated that this probably rises the difficulty of disease detection, and has an effect on screening efficacy. Thus, it is inevitable to adjust the screening strategy when coming into the era of post-HPV vaccination. The current study aims to analyze the changes of HPV genotype infection and the risk of cervical precancerous lesions between HPV vaccine group and control group, and evaluate the impact of HPV16/18 vaccination on cervical cancer screening efficacy by using data of a phase III clinical trial of HPV16/18 vaccine (GSK-107638) in China, so as to supply the evidences for cervical cancer screening policy-making.
Study Data Provided
[{ "PostingID": 2794, "Title": "GSK-107638", "Description": "Efficacy, immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV GSK 580299 vaccine in healthy Chinese female subjects" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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