Clinical trial NCT04022148: The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Cervix
Vaccinia
Keywords: uterine cervical cancer
HPV vaccine
cancer screening
Lead sponsor: University of Fukui
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-07-16
Enrollment: 2800
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese adult women (aged 27-45 years) undergo the cervical cancer screening.

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.

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

Primary outcomes:
measure: The rate of the persistent infection
timeFrame: 48months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Fukui
name: Tetsuji Kurokawa, A
role: STUDY_CHAIR
References:
citation: 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.