NCT06454175

A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years

A Randomised, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 18-45 Years

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants.

Detailed description

A phase 1 random, double blind, placebo control trail was plan to conducted in 72 healthy participants in the 2 age groups(18-45 years old and 9-17 years old). The 72 subjects to be inoculated with middle and high dose vaccine first in sequence if there was no safety issue.

Conditions

• HPV Infection
• HPV-Related Carcinoma
• Genital Wart
• HPV-Related Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	immunization schedule：Month 0，Month 2，Month 6
BIOLOGICAL	15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)	immunization schedule：Month 0，Month 2，Month 6

Timeline

• Start date: 2024-08-03
• Primary completion: 2025-02-05
• Completion: 2025-07-05
• First posted: 2024-06-12
• Last updated: 2025-01-06

Locations

1 site across 1 country: China