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

RECRUITINGPHASE2

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

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

NCT06756269•Shanghai Bovax Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed Description

A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.

Eligibility

Age

9 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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);
+9 more criteria

Locations (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, China

Key Dates

Start Date

January 15, 2025

Primary Completion Date

October 30, 2025

Completion Date

January 13, 2026

Last Updated

December 17, 2025

Enrollment

330

ESTIMATED participants

Conditions

HPV InfectionHPV-Related CarcinomaHPV-Related Intraepithelial NeoplasiaGenital Wart

Interventions

Medium dose for 15-HPV vaccine

BIOLOGICAL

High dose for 15-HPV vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

9-HPV vaccine

BIOLOGICAL

Contacts

Dabin Liang

CONTACT

+86 15977783657 gxirb2018@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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