HPV InfectionPhase 1NCT06454175
A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years
A Phase 1 study testing 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha) in people with HPV Infection and HPV-Related Carcinoma, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants. Read more about this study
- Who is it for?
- Ages 9 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV-Related Carcinoma, Genital Wart
- What is being tested?
- 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2024to 5 Jul 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 9 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants aged 9-45；
- Participans aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
- Participants and/or their guardian sign an informed consent form (a 9-17 year old participant signs an informed notification);
- Axillary temperature was less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
- Be able to comply with study protocol requirements；
- Women were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period，had no birth plan within the 30 days after receiving the whole vaccination;
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- Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study;
- Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.
- Women who receiving hormone test has a regular menstruation for more than one year
Who cannot join
- Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
- Plan to participate other clinical trials during the study period，or participated other clinical trials within 3 months before enrollment, including vaccine or drug;
- Before the first dose is vaccinated, the laboratory test indicators specified in the program are abnormal, except for NCS determined by the clinician;
- History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;
- History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);
- Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosu, rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis or other autoimmune conditions (such as Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);
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- History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;
- History of severe allergy that requires medical intervention, including but not limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura, local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea, angioedema, etc.; History of severe side effect caused by vaccination or severe allergy to any of the components of the investigational vaccine, including histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for injection;
- Suffering from severe cardiovascular disease, severe liver and kidney disease, malignant tumor, and serious infectious disease, such as: tuberculosis, viral hepatitis, etc.;
- Before the enrollment, the physical examination was untreatment or uncontrolled hypertension, (18-45 year olds: systolic blood pressure ≥140mmHg and / or diastolic blood pressure ≥90mmHg, 9-17 year olds: systolic blood pressure ≥120mmHg and / or diastolic blood pressure ≥80mmHg);
- Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor deficiency, clotting disorders, thrombocytopenia, etc.;
- No spleen or functional spleen, and no spleen caused by any condition;
- Receive any Immunosuppressive therapy product within 1 month prior to the first vaccination, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination)，e.g. systemic medication for glucocorticoid (>20mg/day or 2mg/kg/day, continuous use ≥2 weeks), but local medication can be used (such as ointment, eye drops, inhalants) Or nasal spray);
- Receive any immunoglobulin or blood product within 3 months prior to the first injection, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination);
- 3 days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, Aspirin, loratadine, Cetirizine, etc. )
- Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;
- History of mental disorders or family history of mental health disorder (immediate family)
- Plan to move out of the city before the end of the study or leave the local area for a long time during the scheduled study visit;
- The investigator believes that the participant has any condition that may interfere with the assessment of the purpose of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Guangxi
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 18-45 Years
To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants.
Read the detailed description
A phase 1 random, double blind, placebo control trail was plan to conducted in 72 healthy participants in the 2 age groups(18-45 years old and 9-17 years old). The 72 subjects to be inoculated with middle and high dose vaccine first in sequence if there was no safety issue.
- Being tested
- Placebo, 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)
- Medical subject headings
- Papillomavirus Infections, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
immunization schedule：Month 0，Month 2，Month 6
15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)Biological
immunization schedule：Month 0，Month 2，Month 6
| Study group | Role | What they receive |
|---|---|---|
| HPV-vaccine group | Experimental | According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the 15-HPV vaccine Receives: Biological: 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha) |
| Placebo group | Placebo comparator | According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
AE of local and systemic reactions within 30 minutes after each dose
Measured: Up to 30 minutes after any vaccination
Percentage of Participants With Solicited Adverse Events
The percentage of participants with one or more solicited AEs was assessed.
Measured: Up to 14 days after any vaccination
Percentage of Participants With Unsolicited Adverse Events
The percentage of participants with one or more unsolicited AEs was assessed.
Measured: Up to 30 days after any vaccination
Percentage of Participants With Serious Adverse Events
The percentage of participants with one or more SAEs was assessed
Measured: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Percentage of Female Participants With Pregnancy Events
The percentage of participants with Pregnancy Events was assessed
Measured: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start3 Aug 2024
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LIRONG HUANG, Master, Principal investigator, Guangxi Center for Disease Prevention and Crontrol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454175
- Sponsor's protocol ID
- 15-HPV-1001
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT06454175
- Acronym / sponsor ID
- 15-HPV-1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants.
Detailed description
A phase 1 random, double blind, placebo control trail was plan to conducted in 72 healthy participants in the 2 age groups(18-45 years old and 9-17 years old). The 72 subjects to be inoculated with middle and high dose vaccine first in sequence if there was no safety issue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV-vaccine group | Experimental | Biological: 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the 15-HPV vaccine |
| Placebo group | Placebo comparator | Biological: PlaceboAccording to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Participants aged 9-45；
- Participans aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
- Participants and/or their guardian sign an informed consent form (a 9-17 year old participant signs an informed notification);
- Axillary temperature was less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
- Be able to comply with study protocol requirements；
Key exclusion criteria (19 listed)
- Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
- Plan to participate other clinical trials during the study period，or participated other clinical trials within 3 months before enrollment, including vaccine or drug;
- Before the first dose is vaccinated, the laboratory test indicators specified in the program are abnormal, except for NCS determined by the clinician;
- History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;
- History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);
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 |
|---|---|---|
| Placeboimmunization schedule：Month 0，Month 2，Month 6 | Biological | Placebo group |
| 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha)immunization schedule：Month 0，Month 2，Month 6 | Biological | HPV-vaccine group |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: Up to 30 minutes after any vaccination
AE of local and systemic reactions within 30 minutes after each dose
Percentage of Participants With Solicited Adverse Events
Time frame: Up to 14 days after any vaccination
The percentage of participants with one or more solicited AEs was assessed.
Percentage of Participants With Unsolicited Adverse Events
Time frame: Up to 30 days after any vaccination
The percentage of participants with one or more unsolicited AEs was assessed.
Percentage of Participants With Serious Adverse Events
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
The percentage of participants with one or more SAEs was assessed
Percentage of Female Participants With Pregnancy Events
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
The percentage of participants with Pregnancy Events was assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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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.
LIRONG HUANG, Master principal investigator
Guangxi Center for Disease Prevention and Crontrol
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 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha) in people with HPV Infection and HPV-Related Carcinoma, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Jan 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 China. 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?
Results are not available in the source record.
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?
Percentage of Participants With Adverse Events (time frame: Up to 30 minutes after any vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2025.