Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

NCT04422366 | Recruiting Phase 3

• 1 other identifier: 9-HPV-3001
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

Conditions

Cervical Cancer; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN3; VaIN1; VaIN2; VaIN3; Genital Wart; VIN 1; VIN 2; VIN 3; AIS

Outcome Measures

Primary Outcomes (1)

• The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

Secondary Outcomes (19)

• The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

• The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

• The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

• The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

• The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3

  1 month post vaccination 3 (Month 7) up to Month 84

Study Arms (2)

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52

EXPERIMENTAL

Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

Biological: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

GARDASIL®

ACTIVE COMPARATOR

Participants in this arm would receive GARDASIL®

Biological: GARDASIL®

Interventions

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) BIOLOGICAL

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52

GARDASIL® BIOLOGICAL

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule

GARDASIL®

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (If the "\*" option is not met during screening, the visit can be rescheduled)
• Chinese women aged 20-45 who can provide legal identification and have a sexual life history;
• The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;
• Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements;
• Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal;
• \*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including anal, vaginal, or genital/genital contact of the same or opposite sex) for 48 hours prior to any visit that includes gynecological sample collection, and to refrain from vaginal flushing, vaginal cleansing, or use of vaginal medications or preparations for 72 hours;
• When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml cox-hcg), they were not in the lactation period and had no family planning within 7 months after enrollment (1 month before whole-course inoculation).2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures include: the pill, injection or embedded contraception, slow-release local birth control pills, hormone patch, the intrauterine device (IUD), sterilization, abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and emergency contraception is unacceptable contraception;
• \*body temperature \<37.3℃ (underarm body temperature)

You may not qualify if:

• Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine and have received a vaccine/placebo vaccination;
• Previous positive history of HPV;
• Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H), atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;
• Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.);
• Received total hysterectomy or pelvic radiotherapy;
• Cervical insufficiency or abnormal cervical structure (judged by the results of routine gynecological examination);
• Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal) or have obvious condyloma;
• A history of seizures, convulsions or convulsions, or a family history of mental illness;
• Have participated in other gynecology-related clinical trials within 6 months, and have used or plan to use other investigational or unregistered products (drugs or vaccines) other than the vaccine in this study within 3 months;
• A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.A history of severe adverse reactions to previous vaccinations or a history of severe allergies to any of the components of the vaccine under study (histidine, polysorbate, aluminum phosphate, sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection) (such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe urticaria, etc.);
• Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination, or plans to receive such product within the next 7 months (1 month prior to the full course of vaccination);
• Subjects present/present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
• Immunosuppressant therapy within 1 month before the first dose of vaccination, such as long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks, such as prednisone or similar drugs;Topical administration (such as ointment, eye drops, inhalant or nasal spray) not exceeding the recommended dosage in the directions or showing any signs of systemic exposure) or planning to receive such treatment within the next 7 months (1 month before the full course of inoculation);
• Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
• Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant tumor with complications;

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (1)

Liuzhou center for disease control and prevention

Liuchow, Guangxi, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata

Interventions

Vaccines, Synthetic; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Vaginal Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Central Study Contacts

Yi Mo, Master

CONTACT

+8613788686968; moyi0415@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: June 9, 2020
• Study Start: April 28, 2020
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2029
• Last Updated: June 7, 2024

Record last verified: 2024-04

Locations

CN (1)