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Completed

NCT Number: NCT07081334

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

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

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Key information

Conditions

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

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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
  • Anticoagulants: anticoagulants such as coumarin/warfarin or new oral anticoagulants/antiplatelet agents
  • Have or have had a history of myocardial infarction
  • Have had anaphylaxis or serious adverse events related to the vaccine
  • Hypersensitivity to any investigational drug or component (including aluminum, yeast)
  • History of alcohol or other substance abuse
  • History of malignancy
  • 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
  • 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.
  • 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)
  • Pregnant or lactating women
  • 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
  • For any other reason, the investigator considers you unsuitable to be a subject in this study.

Treatment and study plan

PV-001

Biological

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

PEV-001

Biological

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

Primary outcomes

  1. Safety assessment

    Time frame: 180 days after last dose of vaccination

    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).

Secondary outcomes

  1. Exploratory immunogenicity assessment

    Time frame: 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)

    Antibody titers (GMTs) and fold increases (GMRs), measured by ELISA, will be evaluated at 4 months after the second dose and 28 days after the third dose, relative to baseline levels assessed prior to the first dose of the investigational product.

    Neutralizing antibody titers (GMTs) and fold increases (GMRs) against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured using a pseudovirus-based neutralization assay at 4 months after the second dose (Visit 8) and 28 days after the third dose (Visit 10), relative to baseline levels measured prior to the first dose of the investigational product (Visit 1).

Sponsors and collaborators

Lead sponsor

POSVAX

Other

Registry information

Official study title

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

Acronym: HPV

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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