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

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

Timeline

Start

2022-08-17

Primary completion

2024-04-29

Completion

2025-01-30

Publications

• Kim JH, Lee YK, Cho HB, Choi JW, Mun GI, Song OG, Hong J, Kim HJ, Lee A, Choo S, Kim HJ. Evaluation of the safety and immunogenicity of a 9-valent human papillomavirus vaccine produced in Saccharomyces cerevisiae using a heating-chilling process for virus-like particle antigen assembly: a double-blind, randomized, placebo-controlled phase 1 clinical trial. Lancet Reg Health West Pac. 2025 Sep 19;62:101686. doi: 10.1016/j.lanwpc.2025.101686. eCollection 2025 Sep.

Drugs

Indications