15-valent HPV vaccine for people aged 9–45 in China.

A Randomised, Double-blind, Placebo and Positive Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 9-45 Years

This trial will test whether a 15‑valent HPV vaccine is safe and prompts immune responses in people aged 9–45.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 9 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06756269 on ClinicalTrials.gov

What this trial studies

This is a phase 2, randomized, double‑blind trial with both placebo and active (9‑valent) comparators enrolling about 330 healthy participants in two age cohorts (9–17 and 18–45 years). Participants will be randomized to receive a medium or high dose of the 15‑valent vaccine, placebo, or the licensed 9‑HPV vaccine, with safety monitoring and measurement of antibody responses to the vaccine HPV types. The primary focus is on safety and immunogenicity endpoints rather than clinical disease outcomes. The trial is being conducted at the Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention in Nanning, China.

Who should consider this trial

Good fit: Healthy individuals aged 9–45 who can provide legal consent (or have guardian consent for minors), are not pregnant, and can comply with study procedures are ideal candidates.

Not a fit: People outside the 9–45 age range, those who are pregnant or unable/unwilling to follow the protocol, or those with contraindications to vaccination are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could broaden protection against more HPV types and help reduce HPV‑related disease.

How similar studies have performed: Licensed 9‑valent HPV vaccines have demonstrated strong safety and effectiveness, while higher‑valent formulations like a 15‑valent vaccine are newer and still being tested in clinical trials.

Eligibility criteria

Inclusion Criteria:

1. Participants aged 9-45；
2. Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
3. Participants and/or their guardian sign an informed consent form;
4. Axillary temperature less than 37.3 ℃（\>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
5. Be able to comply with study protocol requirements；
6. Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;
7. 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.

Exclusion Criteria:

1. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
2. Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,
3. History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;
4. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;
5. 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.);
6. Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection/AIDS, SCID; Or Autoimmune Diseases (such as systemic lupus erythematosu, Rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis, Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);
7. History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;
8. 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;
9. Severe diseases, as determined by the investigator, that affect vaccination eligibility, whether past or current, include severe cardiovascular disease, severe liver and kidney disease, malignant tumor, and serious infectious disease, such as: tuberculosis, viral hepatitis, etc.;
10. Before the enrollment, the physical examination was untreatment or uncontrolled hypertension, (18-45 year old: systolic blood pressure ≥140mmHg and / or diastolic blood pressure ≥90mmHg, 9-17 year old: systolic blood pressure ≥120mmHg and / or diastolic blood pressure ≥80mmHg);
11. Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor deficiency, clotting disorders, thrombocytopenia, etc.;
12. No spleen or functional spleen, and no spleen caused by any condition;
13. 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);
14. 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);
15. 3 days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, loratadine, Cetirizine, etc. )
16. Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;
17. History of mental disorders or family history of mental health disorder (immediate family);
18. 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;
19. The investigator believes that the participant has any condition that may interfere with the assessment of the purpose of the study.

Where this trial is running

Nanning, Guangxi

• Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention — Nanning, Guangxi, China (Recruiting)

Study contacts

• Principal investigator: Yi Mo, Master — Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
• Study coordinator: Dabin Liang

Conditions HPV Infection; HPV-Related Carcinoma; HPV-Related Intraepithelial Neoplasia; Genital Wart