NCT06465914

A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males

A Randomized, Double-blinded, Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine (Hansenula Polymorpha) in Chinese Males Aged 18-45 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,000 (actual)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.

Detailed description

The primary aim of this clinical trial is to evaluate the efficacy of the 9-valent HPV vaccine in men aged 18-45 years old. It will also learn about the safety and immunogenicity of the 9-valent HPV vaccine. Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0, 2, 6 month immunization program. Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information, keeping a diary of their symptoms and medications.

Conditions

• Genital Wart
• Penile Cancer
• Anal Cancer
• PIN-1
• PIN2
• PIN3
• AIN1
• AIN2
• AIN3
• HPV-Related Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)	Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).
BIOLOGICAL	Placebo	Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

Timeline

• Start date: 2024-07-11
• Primary completion: 2027-07-30
• Completion: 2030-07-30
• First posted: 2024-06-20
• Last updated: 2024-12-12

Locations

5 sites across 1 country: China