臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 26, 2025
Last modified on	Dec. 17, 2025
Trial ID	jRCTs031240746

Scientific Title	A Randomized Clinical Trial to Compare the Efficacy and Immunogenicity of Single-Dose versus Two-Dose HPV Vaccination in Men (HPV-ONE)
Public Title	A Randomized Clinical Trial to Compare the Efficacy and Immunogenicity of Single-Dose versus Two-Dose HPV Vaccination in Men (HPV-ONE)

Contact for Scientific Queries	Name	Ando Naokatsu
	Affiliation	National Center for Global Health and Medicine, Japan Institute for Health Security
	Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
	Telephone	+81-3-3202-7181
	E-mail	ando.n@jihs.go.jp
Contact for Public Queries	Name	Ando Naokatsu
	Affiliation	National Center for Global Health and Medicine, Japan Institute for Health Security
	Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
	Telephone	+81-3-3202-7181
	E-mail	ando.n@jihs.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 26, 2025
Actual date of first enrollment		April. 15, 2025
Target sample size		220
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Male individuals aged 18 years or older at the time of consent. 2. Individuals who have provided written informed consent to participate in the study.
	Exclusion Criteria	1. Individuals with known allergies to the treatment medication. 2. Individuals who regularly use steroids or immunosuppressive agents. 3. Individuals with a history of receiving the 2-valent, 4-valent, or 9-valent HPV vaccine. 4. Individuals deemed unsuitable for study participation by the attending physician.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Human Papillomavirus infection
Intervention(s)		The recombinant 9-valent human papillomavirus vaccine will be administered in one or two doses. In the two-dose group, the second dose will be administered at 6-month (between 5 to 8 months) following the first dose.
Health Condition(s) Keyword		HPV infection, HPV-associated cancer, Oropharyngeal cancer, Anal canal, Penile cancer
Intervention(s) Keyword		9-valent HPV vaccine
Health Condition(s) Code		D000094302
Intervention(s) Code		D053918
Primary Outcome(s)		HPV16 IgG seropositivity rate at Week 96
Secondary Outcome(s)		At Week 48 and Week 96 IgG seropositivity rate for high-risk HPV IgG titer for high risk HPV New persistent infection in the pharynx or anus A new persistent infection in the pharynx or anus that was not detected at baseline. Persistent infection is defined as positive results at two consecutive observation points. New cytological abnormalities The appearance of new cytological abnormalities classified as ASCUS or higher that were not detected at baseline. Histological abnormalities The appearance of new histological abnormalities classified as AIN2 or higher that were not detected at baseline. HPV related malignancies

Source of Monetary Support	National Center for Global Health and Medicine, Japan Institute for Health Security

Name of Certified Review Board	Certified Review Board of Japan Institute for Health Security
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-3202-7181
E-Mail	kenkyu-shinsa@jihs.go.jp
Approval Status	Approval
Date of approval	Nov. 18, 2024

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
4	Dec. 17, 2025	(this page)	Changes
3	May. 01, 2025	Detail	Changes
2	May. 01, 2025	Detail	Changes
1	Mar. 26, 2025	Detail

List of change history