HPV InfectionsPhase 1HPVNCT07081334
A Phase 1 Study of PV-001 9-valent Human Papillomavirus(HPV) Vaccine
A Phase 1 study testing PV-001 and PEV-001 in people with HPV Infections, run by POSVAX at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- What is being tested?
- PV-001 and PEV-001
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2022to 30 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Assess the Safety and Exploratory Immunogenicity of PV-001
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
- Being tested
- PV-001, PEV-001
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PV-001Biological
9-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
PEV-001Biological
PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate.
| Study group | Role | What they receive |
|---|---|---|
| PV-001 vaccine | Experimental | Not described Receives: Biological: PV-001 |
| PEV-001 | Placebo comparator | Not described Receives: Biological: PEV-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 180 days after last dose of vaccination
Secondary outcomes (1)
Exploratory immunogenicity assessment
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Aug 2022
- Primary completion29 Apr 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- POSVAX
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081334
- Sponsor's protocol ID
- POCLI-101
- Acronym
- HPV
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41048471
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Assess the Safety and Exploratory Immunogenicity of PV-001
- ClinicalTrials.gov ID
- NCT07081334
- Acronym / sponsor ID
- HPV / POCLI-101
- Conditions
- HPV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- POSVAXUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PV-001 vaccine | Experimental | Biological: PV-001 |
| PEV-001 | Placebo comparator | Biological: PEV-001 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PV-0019-valent vaccine containing antigens for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Biological | PV-001 vaccine |
| PEV-001PEV-001 is a formulation of the PV-001 vaccine that excludes the HPV antigens and contains only aluminum phosphate. | Biological | PEV-001 |
Primary outcome
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).
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 41048471Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PV-001 and PEV-001 in people with HPV Infections, run by POSVAX at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: 180 days after last dose of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07081334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.