HPV Infections
Conditions
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
Interventions
BIOLOGICALPV-001
9-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
BIOLOGICALPEV-001
PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate.
Sponsors
POSVAX
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
Countries
South Korea
Outcome results
None listed