Clinical trial NCT06866574: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Penile/Perineal /Perianal Intraepithelial Neoplasia
Anal Intraepithelial Neoplasia
Penile/perianal/perineal Cancer
Anal Cancer
Genital Warts
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
First posted: 2025-03-10
Enrollment: 9300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male participants aged 18-45 years at the time of the first vaccination.
2. 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.
3. No more than 5 sexual partners so far.
4. Participants who agree to adopt effective contraceptive measures within 30 days after each vaccination.
5. 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).

Exclusion Criteria:

1. 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.
2. Axillary temperature \> 37.0°C.
3. 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).
4. Presence of clinically vident genital warts, external genital lesions, or anal lesions which may suggest sexually transmitted diseases on the day of enrollment.
5. 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).
6. Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them within 7 months after the first dose.
7. 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.
8. Administration of inactivated vaccine within 14 days or live vaccine within 21 days before vaccination.
9. 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.
10. 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).
11. 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).
12. Asthma, with unstable condition over the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroid administration.
13. 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.
14. History of severe medical conditions (with unstable condition that may require emergency treatment or hospitalization), as inquiried by study investigator.
15. Self-report past coagulation disorders or abnormal coagulation function.
16. 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.
17. 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.

Primary outcomes:
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)
timeFrame: 0-78 months
measure: 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
timeFrame: 0-78 months
Secondary outcomes:
measure: 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)
timeFrame: 0-78 months
measure: Seroconversion and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
timeFrame: 0-7 months
measure: 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
timeFrame: 18-78 months
measure: Adverse events/reactions occurred within 30 days after each vaccination
timeFrame: Within 30 days (Day 0-30) after each vaccination
measure: Serious adverse events occurred throughout the study
timeFrame: 0-78 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Center for Disease Control and Prevention
state: Fujian
city: Chengdu
country: China
facility: Sichuan Provincial Center for Disease Control and Prevention
state: Sichuan
city: Kunming
country: China
facility: Yunnan Provincial Center for Disease Control and Prevention
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Center for Disease Control and Prevention
state: Zhejiang
Study officials:
affiliation: Xiamen University
name: Jun Zhang, Master
role: STUDY_CHAIR
affiliation: Yunnan Provincial Center for Disease Control and Prevention
name: Xiaoqiang Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Long Sui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: