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About
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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