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

NCT04022148 | Unknown FDA Drug

• 1 other identifier: C2018001F
• Study Type: observational
• Target: 2,800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer of Cervix; Vaccinia

Keywords

uterine cervical cancer; HPV vaccine; cancer screening

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Gardasil BIOLOGICAL

Experimental arm: Vaccine group VS Control arm: Non-Vaccine group

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.

You may qualify if:

• Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020
• years-old
• Intact uterus
• Willing to undergo the HPV-DNA test (cobas4800) within 12 months

You may not qualify if:

• Pregnant women
• Undergo treatment or the follow-up evaluation for CIN within the previous 12 months
• Previously administered HPV vaccine

Sponsors & Collaborators

• University of Fukui: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Kurokawa T, Yamamoto M, Onuma T, Tsuyoshi H, Shinagawa A, Chino Y, Yoshida Y. The study protocol of the evaluation for the preventive efficacy of the HPV vaccine for persistent HPV16/18 infection in Japanese adult women: the HAKUOH study. BMC Cancer. 2020 Nov 3;20(1):1056. doi: 10.1186/s12885-020-07563-0.

  PMID: 33143690 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaccinia

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Tetsuji Kurokawa, A

  University of Fukui

  STUDY CHAIR

Central Study Contacts

Tetsuji Kurokawa, AP

CONTACT

+81-776-61-8392; kurotetu@u-fukui.ac.jp

Yoko Chino, A

CONTACT

+81-776-61-8392; yoyoyo@u-fukui.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 16, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share