HPV InfectioNPhase 3NCT05262010
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
A Phase 3 study testing 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) in people with HPV InfectioN and HPV-Related Carcinoma, run by National Vaccine and Serum Institute, China at 8 sites in China.
Trial summary
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV InfectioN, HPV-Related Carcinoma
- What is being tested?
- 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13,500 participants
- Where
- 8 sitesChina
- Study dates
- 4 Jun 2022to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-gynecological related
- *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- *Axillary body temperature <37.3℃ on the day of enrollment;
- The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
- No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
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- The subject has a negative urine pregnancy test on the day before vaccination.
- Gynecology related
- *Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
- *Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.
Who cannot join
- First dose exclusion criteria:
- (Visits may be rescheduled if the criteria described in the "" option are met at screening)
- Non-gynecological related
- * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
- *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
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- *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
- History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
- Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
- 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
- Previous splenectomy or impaired spleen function;
- Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
- Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
- Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
- Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
- The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).
- Gynecology related
- *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
- *The subject is in the menstrual period;
- *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
- Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);
- Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
- Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.
- If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.
- Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
- Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Hechi Yizhou District Center for Disease Control and Prevention
Hechi, Guangxi, 546300
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, 542899
Lianyuan Center for Disease Control and Prevention
Lianyuan, Hunan, 417100
Mianyang Youxian District Center for Disease Control and Prevention
Mianyang, Sichuan, 621000
Neijiang Shizhong District Center for Disease Control and Prevention
Neijiang, Sichuan, 641000
Qiyang Center for Disease Control and Prevention
Wuxi, Hunan, 426100
Yongji Center for Disease Control and Prevention
Yongji, Shanxi, 044500
Yuanqu Center for Disease Control and Prevention
Yuncheng, Shanxi, 043700
About this study
Official title: A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
- Conditions
- HPV InfectioN, HPV-Related Carcinoma
- Being tested
- 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha), placebo
- Keywords
- HPV Infection HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)Biological
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
placeboBiological
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine Receives: Biological: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) |
| placebo | Placebo comparator | According to the 0, 2, and 6 months immunization program, 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.
Person-years incidence of CIN2+ associated with HPV6/11/16/18.
Measured: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
Measured: 1 month after 3 doses of vaccine
Secondary outcomes (15)
Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.
Measured: 1 month after 3 doses of vaccine
Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58
Measured: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6
Measured: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Measured: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18
Measured: After at least 1 dose of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68
Measured: After at least 1 dose of vaccine
Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.
Measured: After at least 1 dose of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Measured: After at least 1 dose of vaccine
AE incidence and severity distribution
Measured: The first dose of vaccination to within 1 month after the full vaccination
AE incidence and severity distribution
Measured: 0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days)
SAE incidence
Measured: During the study，an average of 6 year
Number of pregnant
Measured: The first dose of vaccination to within 6 months after the full vaccination
Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)
Previous pregnancy, current pregnancy mode, neonatal information
Measured: The first dose of vaccination to within 6 months after the full vaccination
To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Measured: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Measured: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start4 Jun 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Beijing Kantorico Statistical Technology Co., Ltd., Guangxi Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262010
- Sponsor's protocol ID
- GXIRB2021-0029-1
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2022
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT05262010
- Acronym / sponsor ID
- GXIRB2021-0029-1
- Conditions
- HPV InfectioN, HPV-Related Carcinoma
- Keywords
- HPV Infection HPV vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13,500 participants (estimated)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Beijing Kantorico Statistical Technology Co., Ltd., Guangxi Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Centers for Disease Control and Prevention, China
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Mar 2022 (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.
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Biological: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine |
| placebo | Placebo comparator | Biological: placeboAccording to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- non-gynecological related
- *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- *Axillary body temperature <37.3℃ on the day of enrollment;
- The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
Key exclusion criteria (26 listed)
- (Visits may be rescheduled if the criteria described in the "" option are met at screening)
- Non-gynecological related
- * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
- *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
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 |
|---|---|---|
| 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine | Biological | experiment group |
| placeboAccording to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo | Biological | placebo |
Primary outcome
Person-years incidence of CIN2+ associated with HPV6/11/16/18.
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
Time frame: 1 month after 3 doses of vaccine
15 secondary outcomes
Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time frame: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18
Time frame: After at least 1 dose of vaccine
Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68
Time frame: After at least 1 dose of vaccine
Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.
Time frame: After at least 1 dose of vaccine
Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).
Time frame: After at least 1 dose of vaccine
AE incidence and severity distribution
Time frame: The first dose of vaccination to within 1 month after the full vaccination
AE incidence and severity distribution
Time frame: 0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days)
SAE incidence
Time frame: During the study，an average of 6 year
Number of pregnant
Time frame: The first dose of vaccination to within 6 months after the full vaccination
Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)
Time frame: The first dose of vaccination to within 6 months after the full vaccination
To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time frame: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)
Time frame: 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) in people with HPV InfectioN and HPV-Related Carcinoma, run by National Vaccine and Serum Institute, China at 8 sites 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 10 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Person-years incidence of CIN2+ associated with HPV6/11/16/18. (time frame: 1 month after 3 doses of vaccine). The study lists 2 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 28 Oct 2026.