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

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ClinicalTrials.gov Identifier: NCT04022148
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Yoshio Yoshida, University of Fukui

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer of Cervix Vaccinia Biological: Gardasil

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: 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.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Biological: Gardasil
    Experimental arm: Vaccine group VS Control arm: Non-Vaccine group


Primary Outcome Measures :
  1. The rate of the persistent infection [ Time Frame: 48months ]
    Persistent infection is the cases that the cells from women with HPV16/18 genotype overexpressed p16 and Ki67.



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Ages Eligible for Study:   27 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022148


Contacts
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Contact: Tetsuji Kurokawa, AP +81-776-61-8392 kurotetu@u-fukui.ac.jp
Contact: Yoko Chino, A +81-776-61-8392 yoyoyo@u-fukui.ac.jp

Sponsors and Collaborators
University of Fukui
Merck Sharp & Dohme Corp.
Investigators
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Study Chair: Tetsuji Kurokawa, A University of Fukui

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Responsible Party: Yoshio Yoshida, Professor, University of Fukui
ClinicalTrials.gov Identifier: NCT04022148     History of Changes
Other Study ID Numbers: C2018001F
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yoshio Yoshida, University of Fukui:
uterine cervical cancer
HPV vaccine
cancer screening
Additional relevant MeSH terms:
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Vaccinia
Uterine Cervical Neoplasms
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs