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

NCT ID: NCT04022148

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Cancer of Cervix; Vaccinia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Gardasil

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Fukui

OTHER

Sponsor Role: lead

Responsible Party

Yoshio Yoshida

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tetsuji Kurokawa, A

Role: STUDY_CHAIR

University of Fukui

Central Contacts

Tetsuji Kurokawa, AP

Role: CONTACT

kurotetu@u-fukui.ac.jp

+81-776-61-8392

Yoko Chino, A

Role: CONTACT

yoyoyo@u-fukui.ac.jp

+81-776-61-8392

References

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.

Reference Type: DERIVED

PMID: 33143690 (View on PubMed)

Other Identifiers

C2018001F

Identifier Type: -

Identifier Source: org_study_id