Human Papillomavirus infection HPV infection, HPV-associated cancer, Oropharyngeal cancer, Anal canal, Penile cancer
Conditions
Interventions
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
D053918
Sponsors
Ando Naokatsu
Eligibility
Sex/Gender
Male
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV16 IgG seropositivity rate at Week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactNaokatsu Ando
National Center for Global Health and Medicine, Japan Institute for Health Security
Outcome results
None listed