To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

NCT06756269 | Recruiting Phase 2 DMC

• 1 other identifier: 15-HPV-2001
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Adverse Events

  AE of local and systemic reactions within 30 minutes after each dose

  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.

  Up to 14 days after any vaccination

• Percentage of Participants With Unsolicited Adverse Events

  Percentage of Participants With Unsolicited Adverse Events

  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

  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

  From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Secondary Outcomes (3)

• Immunogenicity after receiving 3 doses of 15-HPV vaccine

  Up to 31 days after the third vaccination

• Immunogenicity of 15-HPV vaccine

  Up to 31 days after the third vaccination

• Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants

  Up to 31 days after the third vaccination

Study Arms (4)

Medium dose for 15-HPV vaccine

EXPERIMENTAL

Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Biological: Medium dose for 15-HPV vaccine

High dose for 15-HPV vaccine

EXPERIMENTAL

Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Biological: High dose for 15-HPV vaccine

Placebo

PLACEBO COMPARATOR

Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Biological: Placebo

9-HPV-vaccine

ACTIVE COMPARATOR

Participants aged 18-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Biological: 9-HPV vaccine

Interventions

Medium dose for 15-HPV vaccine BIOLOGICAL

Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Medium dose for 15-HPV vaccine

High dose for 15-HPV vaccine BIOLOGICAL

Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

High dose for 15-HPV vaccine

Placebo BIOLOGICAL

Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Placebo

9-HPV vaccine BIOLOGICAL

Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

9-HPV-vaccine

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 9-45；
• Participants 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;
• Axillary temperature 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 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;
• 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.

You may not qualify if:

• 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 （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,
• History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;
• History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;
• 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/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.);
• 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;
• 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.;
• 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);
• 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);
• 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. )

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530028, China

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yi Mo, Master

  Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dabin Liang

CONTACT

+86 15977783657; gxirb2018@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: January 13, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)