NCT07081334

A Phase 1 Study of PV-001 9-valent Human Papillomavirus(HPV) Vaccine

Phase 1 Study to Assess the Safety and Exploratory Immunogenicity of PV-001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: POSVAX · Academic / Other
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study Title: Evaluation of the Safety and Immunogenicity of a Third Dose of PV-001 in Healthy Women Aged 19-45 Objective: To assess the safety and antibody response of a third dose of PV-001 in healthy adult female participants. Key Questions Is PV-001 safe? What adverse events may occur after vaccination? Does PV-001 produce an effective immune response? Participant Activities : Three clinic visits for screening and vaccination Blood samples collected on a set schedule Monitoring for side effects after vaccination

Conditions

• HPV Infections

Interventions

Type	Name	Description
BIOLOGICAL	PV-001	9-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
BIOLOGICAL	PEV-001	PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate.

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-04-29
• Completion: 2025-01-30
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: South Korea