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

Cancer of Cervix Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04022148
• Other study ID #: C2018001F
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: University of Fukui
• Contact: Tetsuji Kurokawa, AP
• Phone: +81-776-61-8392
• Email: kurotetu[@]u-fukui.ac.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 27 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Cervix
• Uterine Cervical Neoplasms
• Vaccinia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Fukui	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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