Penile/Perineal /Perianal Intraepithelial NeoplasiaPhase 3NCT06866574

A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males

A Phase 3 study testing Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli) and Aluminum Adjuvant in people with Penile/Perineal /Perianal Intraepithelial Neoplasia and Anal Intraepithelial Neoplasia, run by Xiamen University at 4 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer
What is being tested?: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli) and Aluminum Adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9,300 participants
Where: 4 sitesChina
Study dates: 11 Apr 2025to 30 Sep 2031
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male participants aged 18-45 years at the time of the first vaccination.
Be able to comprehend the trial procedures and comply with the protocol requirements (e.g., providing biological samples, completing diary/contact cards, and attending scheduled follow-up visits), and provide written informed consent.
No more than 5 sexual partners so far.
Participants who agree to adopt effective contraceptive measures within 30 days after each vaccination.
No prior history of HPV-related anal-genital lesions (e.g., genital warts, penile/perineal/perianal intraepithelial neoplasia, penile/perineal/perianal cancer, anal intraepithelial neoplasia, and anal cancer).

Who cannot join

Participants who have received or plan to receive any other HPV vaccine during the study period, or have participated in any other HPV-related clinical trial.
Axillary temperature > 37.0°C.
Engagement in sexual activity (including vaginal/anal intercourse, or any genital contact) within 48 hours prior to any swab/anal cytology specimen collection visit, or any other behavior that may affect the anal-genital examination and specimen collection (anal procedures only applicable to MSM participants).
Presence of clinically vident genital warts, external genital lesions, or anal lesions which may suggest sexually transmitted diseases on the day of enrollment.
Participants who received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy (≥14 consecutive days) within 6 months prior to enrollment, except local treatment (e.g., ointment, eyedrops, inhalants or nasal sprays).
Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them within 7 months after the first dose.

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Use of any investigational or non-registered product (drug or vaccine) within 30 days prior to vaccination, or intending to use them or participate in another clinical trial during the study period.
Administration of inactivated vaccine within 14 days or live vaccine within 21 days before vaccination.
Any acute illness requiring systemic antibiotic or antiviral treatment within 5 days prior to vaccination, or axillary temperature ≥38.0°C within 3 days prior to vaccination.
A state of immunocompromised condition as inquiried by study investigator, e.g., congenital or acquired immunodeficiency diseases, HIV infection, immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, or any other condition that may affect immune response), primary diseases or cancer of major organs (such as heart, liver, spleen, lungs, kidneys).
History of severe allergy, including serious adverse reactions (e.g., dyspnea, angioedema) to any previous vaccination, or severe allergy to any component of the trial vaccine (recombinant VLP protein, sodium dihydrogen phosphate, disodium hydrogen phosphate, polysorbate, aluminum hydroxide).
Asthma, with unstable condition over the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroid administration.
History of hypertension or hypotension, not stably controlled despite regular medication, or systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or systolic blood pressure <90 mmHg, measured in both arms at rest.
History of severe medical conditions (with unstable condition that may require emergency treatment or hospitalization), as inquiried by study investigator.
Self-report past coagulation disorders or abnormal coagulation function.
Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that did not require treatment in the past 3 years.
Any medical, psychological, social, occupational, or other condition that may affect the conduct of the clinical trial, according to the investigator's judgment after medical history and physical examination.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Sichuan Provincial Center for Disease Control and Prevention
Chengdu, Sichuan
Fujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, Zhejiang
Yunnan Provincial Center for Disease Control and Prevention
Kunming, Yunnan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Aluminum Adjuvant-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E. Coli) in Chinese Males Aged 18 to 45 Years

Conditions: Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer, Genital Warts
Being tested: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli), Aluminum Adjuvant
Medical subject headings: Anus Neoplasms, Condylomata Acuminata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)Biological
Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)
Aluminum AdjuvantBiological
Participants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).

Study groups in NCT06866574
Study group	Role	What they receive
Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)	Experimental	Participants in this arm would receive Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli). Receives: Biological: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)
Aluminum Adjuvant	Placebo comparator	Participants in this arm would receive Aluminum Adjuvant. Receives: Biological: Aluminum Adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, Penile/Perineal/Perianal Intraepithelial Neoplasia 1+ (PIN1+), and Penile/Perineal/Perianal cancer (pooled across all specified HPV types)
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, PIN1+ and Penile/Perineal/Perianal cancer (pooled across all specified HPV types) in the Per-Protocol Set (PPS) population.
Measured: 0-78 months
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated Anal Intraepithelial Neoplasia 1+ (AIN1+) and Anal cancer (pooled across all specified HPV types), only in MSM participants
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated AIN1+ and Anal cancer in the PPS population of MSM participants.
Measured: 0-78 months

Secondary outcomes (5)

HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types)
To evaluate the efficacy of the investigational vaccine in preventing HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types).
Measured: 0-78 months
Seroconversion and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
To evaluate the immunogenicity of the investigational vaccine.
Measured: 0-7 months
Seropositivity and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 18, 30, 42, 54, 66 and 78
To evaluate the long-term immunopersistence of the investigational vaccine.
Measured: 18-78 months
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate the safety of the investigational vaccine.
Measured: Within 30 days (Day 0-30) after each vaccination
Serious adverse events occurred throughout the study
To evaluate the safety of the investigational vaccine.
Measured: 0-78 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 202530 Sep 2031

First posted10 Mar 2025
Study start11 Apr 2025
Primary completion30 Sep 2031 (estimated)
Study completion30 Sep 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Penile/Perineal /Perianal Intraepithelial NeoplasiaStudies 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: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 9,300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06866574
Sponsor's protocol ID: HPV-PRO-015
Status last verified: Jul 2025
First submitted: 27 Feb 2025
Last updated: 31 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Aluminum Adjuvant-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E. Coli) in Chinese Males Aged 18 to 45 Years
ClinicalTrials.gov ID: NCT06866574
Acronym / sponsor ID: HPV-PRO-015
Conditions: Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer, Genital Warts
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 9,300 participants (estimated)
Lead sponsor: Xiamen UniversityUniversity, hospital or other
Collaborators: Xiamen Innovax Biotech Co., Ltd
Study start: 11 Apr 2025 (actual)
Primary completion: 30 Sep 2031 (estimated)
Study completion: 30 Sep 2031 (estimated)
First posted: 10 Mar 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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)	Experimental	Biological: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)Participants in this arm would receive Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli).
Aluminum Adjuvant	Placebo comparator	Biological: Aluminum AdjuvantParticipants in this arm would receive Aluminum Adjuvant.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male participants aged 18-45 years at the time of the first vaccination.
Be able to comprehend the trial procedures and comply with the protocol requirements (e.g., providing biological samples, completing diary/contact cards, and attending scheduled follow-up visits), and provide written informed consent.
No more than 5 sexual partners so far.
Participants who agree to adopt effective contraceptive measures within 30 days after each vaccination.
No prior history of HPV-related anal-genital lesions (e.g., genital warts, penile/perineal/perianal intraepithelial neoplasia, penile/perineal/perianal cancer, anal intraepithelial neoplasia, and anal cancer).

Key exclusion criteria (17 listed)

Participants who have received or plan to receive any other HPV vaccine during the study period, or have participated in any other HPV-related clinical trial.
Axillary temperature > 37.0°C.
Engagement in sexual activity (including vaginal/anal intercourse, or any genital contact) within 48 hours prior to any swab/anal cytology specimen collection visit, or any other behavior that may affect the anal-genital examination and specimen collection (anal procedures only applicable to MSM participants).
Presence of clinically vident genital warts, external genital lesions, or anal lesions which may suggest sexually transmitted diseases on the day of enrollment.
Participants who received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy (≥14 consecutive days) within 6 months prior to enrollment, except local treatment (e.g., ointment, eyedrops, inhalants or nasal sprays).

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
Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)	Biological	Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)
Aluminum AdjuvantParticipants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).	Biological	Aluminum Adjuvant

Primary outcome

HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, Penile/Perineal/Perianal Intraepithelial Neoplasia 1+ (PIN1+), and Penile/Perineal/Perianal cancer (pooled across all specified HPV types)
Time frame: 0-78 months
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, PIN1+ and Penile/Perineal/Perianal cancer (pooled across all specified HPV types) in the Per-Protocol Set (PPS) population.
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated Anal Intraepithelial Neoplasia 1+ (AIN1+) and Anal cancer (pooled across all specified HPV types), only in MSM participants
Time frame: 0-78 months
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated AIN1+ and Anal cancer in the PPS population of MSM participants.

5 secondary outcomes

HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types)
Time frame: 0-78 months
Seroconversion and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
Time frame: 0-7 months
Seropositivity and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 18, 30, 42, 54, 66 and 78
Time frame: 18-78 months
Adverse events/reactions occurred within 30 days after each vaccination
Time frame: Within 30 days (Day 0-30) after each vaccination
Serious adverse events occurred throughout the study
Time frame: 0-78 months

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 31 Jul 2025.

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.

Jun Zhang, Master study chair

Xiamen University

Xiaoqiang Liu, Ph.D. principal investigator

Yunnan Center for Disease Control and Prevention

Long Sui, Ph.D. principal investigator

Obstetrics & Gynecology Hospital of Fudan University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 17 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 31 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 4 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?

HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, Penile/Perineal/Perianal Intraepithelial Neoplasia 1+ (PIN1+), and Penile/Perineal/Perianal cancer (pooled across all specified HPV types) (time frame: 0-78 months). 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?

On the ClinicalTrials.gov record for NCT06866574.

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 31 Jul 2025.