The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years

Study Overview
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Brief Summary
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A nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent HPV6/11/16/18 vaccine for the persistent infection of HPV16 genotype or HPV18 genotype in Japanese women aged 27-45 years.

Detailed Description
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A series of evidence for HPV vaccines has demonstrated the efficacy in young women (Aged less than 26) across the globe. In contrast, limited evidence are available for the efficacy of the quadrivalent HPV6/11/16/18 vaccine in adult women (Aged 27+). Most importantly, evidence for Japanese adult women is not available to date. Nevertheless, , we hypothesize that the quadrivalent HPV6/11/16/18 vaccine demonstrate the efficacy also in Japanese adult women. The outcome from this trial will be the first local evidence, which brings a considerable impact in OB/GY academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of HPV vaccines for young adults. As a consequence, we believe this study will develop a local supportive evidence for prevention of HPV infection by an HPV vaccine in young adults, which results in substantial public health improvement through prevention of HPV infection in Japan where active recommendation is halted long time.

Official Title
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A Nonrandomized, Non-double Blinded Prospective Cohort Study to Evaluate the Preventive Efficacy of Quadrivalent HPV6/11/16/18 Vaccine for the Persistent Infection of HPV16 Genotype or HPV18 Genotype in Japanese Women Aged 27-45 Years.

Conditions
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Cancer of Cervix, Vaccinia

Intervention / Treatment
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* Biological: Gardasil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020 27-45 years-old Intact uterus Willing to undergo the HPV-DNA test (cobas4800) within 12 months Exclusion Criteria: Pregnant women Undergo treatment or the follow-up evaluation for CIN within the previous 12 months Previously administered HPV vaccine

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Gardasil|Experimental arm: Vaccine group VS Control arm: Non-Vaccine group|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of the persistent infection | Persistent infection is the cases that the cells from women with HPV16/18 genotype overexpressed p16 and Ki67. | 48months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterine cervical cancer, HPV vaccine, cancer screening