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

NCT07081334 | Completed Phase 1 DMC

• 1 other identifier: POCLI-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  Adverse Events: Immediate adverse reactions occurring within 30 minutes after administration of the investigational product (e.g., syncope, loss of consciousness, anaphylaxis-related events), Expected local and systemic adverse reactions occurring within 7 days following administration of the investigational product, and Unexpected adverse events occurring from the first dose through 180 days after the third dose (Visit 11).

  180 days after last dose of vaccination

Secondary Outcomes (1)

• Exploratory immunogenicity assessment

  At 4 months after the second dose (Visit 8) and 28 days after the third dose (Visit 10), relative to baseline (Visit 1, prior to the first dose of the investigational product)

Study Arms (2)

PV-001 vaccine

EXPERIMENTAL

Biological: PV-001

PEV-001

PLACEBO COMPARATOR

Biological: PEV-001

Interventions

PV-001 BIOLOGICAL

9-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

PV-001 vaccine

PEV-001 BIOLOGICAL

PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate.

PEV-001

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women between the ages of 19 and 45 years old
• Able to comply with the planned visit schedule for this study to perform the study procedures
• Able to understand and complete the immunization diary provided in this study
• Able to have a specimen collected and tested for a Pap test
• Have been using contraception for 48 hours prior to the screening visit and are able to maintain contraception for the duration of the study
• After receiving and understanding a detailed explanation of this study, they have voluntarily decided to participate and have given written informed consent.

You may not qualify if:

• Previous HPV vaccination or participation in a clinical trial of HPV vaccine
• Previous history of abnormal pap test or colposcopy with abnormal cervical cells
• Previous HPV test positive for one or more of the following types: HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, or positive human papillomavirus genotyping test at screening
• Acute fever (38.0°C or higher) within 24 hours prior to the first dose of the investigational medicinal product
• Positive results of viral tests \[hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test\] at screening or suspected of infection
• Subjects with clinically significant abnormal results of clinical laboratory tests at screening, as judged by the investigator
• Immune response is impaired by genetic defects, human immunodeficiency virus (HIV) infection, or other causes.
• Have a history of neurological disease, such as encephalomyelitis or Guillain-Barre syndrome
• History of HPV-related malignancy (cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, cervical intraepithelial adenocarcinoma, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia)
• Received Immunosuppressive Therapy including radiotherapy, antimetabolites, alkylating agents, cytotoxic agents, or cytotoxic agents within 1 year prior to the first dose of investigational medicinal product.
• Have received an immunosuppressant or immune modifying drug within 6 months prior to the first dose of the investigational drug.
• Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.
• High doses of systemic steroids: Corticosteroids up to 2 mg/kg/day based on Prednisolone or doses of 20 mg/day or more used continuously for more than 14 days are considered high doses and excluded from participation in this study. However, Inhaled, Nasal, Conjunctiva, Intraarticular, Bursal, or Tendon injections, and Topical corticosteroids are allowed regardless of dose.
• Administration of immunoglobulins or blood-derived products within 3 months prior to the first dose of investigational medication
• Have thrombocytopenia, blood coagulation disorders at risk of causing serious bleeding or have received anticoagulants\* within 3 weeks prior to Visit 2

Sponsors & Collaborators

• POSVAX: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 41048471 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 23, 2025
• Study Start: August 17, 2022
• Primary Completion: April 29, 2024
• Study Completion: January 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

KR (1)