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

NCT ID: NCT07081334

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2025-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PV-001 vaccine

Group Type: EXPERIMENTAL

PV-001

Intervention Type: BIOLOGICAL

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

PEV-001

Group Type: PLACEBO_COMPARATOR

PEV-001

Intervention Type: BIOLOGICAL

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

Interventions

PV-001

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

Intervention Type: BIOLOGICAL

PEV-001

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

1. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.

2. 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.

3. Administration of immunoglobulins or blood-derived products within 3 months prior to the first dose of investigational medication

4. Have thrombocytopenia, blood coagulation disorders at risk of causing serious bleeding or have received anticoagulants* within 3 weeks prior to Visit 2

• Anticoagulants: anticoagulants such as coumarin/warfarin or new oral anticoagulants/antiplatelet agents

5. Have or have had a history of myocardial infarction

6. Have had anaphylaxis or serious adverse events related to the vaccine

7. Hypersensitivity to any investigational drug or component (including aluminum, yeast)

8. History of alcohol or other substance abuse

9. History of malignancy

10. Have a serious acute, chronic, or progressive medical condition (e.g., malignancy, cardiovascular, respiratory, endocrine, renal, or hepatic disease, etc.) that, in the opinion of the investigator, may interfere with the progress and completion of this study

11. History of vaccination with any other vaccine within 4 weeks prior to the first dose of the investigational drug or planned vaccination with any other vaccine within 4 weeks after each dose of the investigational drug.

12. Women of childbearing potential who do not agree to use a medically acceptable method of contraception for the duration of the study (hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, double barrier method (combined use such as cervical cap, contraceptive diaphragm with male condom)

13. Pregnant or lactating women

14. Subjects who have received another investigational drug within 6 months prior to the first dose of the investigational drug or who are scheduled to receive another investigational drug during the study

15. For any other reason, the investigator considers you unsuitable to be a subject in this study.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

POSVAX

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 41048471 (View on PubMed)

Other Identifiers

POCLI-101

Identifier Type: -

Identifier Source: org_study_id