A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females

NCT05584332 | Terminated Phase 3 DMC

• 1 other identifier: 4-HPV-3004
• Study Type: interventional
• Target: 3,131
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

Conditions

Cervical Cancer; Genital Wart; CIN1; CIN2; CIN3; Vain I; Vain III; Vin I; Vin II; Vin III; AIS; VAIN - Vaginal Intraepithelial Neoplasia 2

Outcome Measures

Primary Outcomes (1)

• The person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago.

  Over 30 months

Secondary Outcomes (14)

• The person-year incidence of HPV 6-, 11-, 16-, and 18-related 6-month Persistent Infection at least 30 days post Dose 3

  from Month 7 up to Month 60

• The person-year incidence of HPV 6-, 11-, 16-, and 18-related 12-month Persistent Infection at least 30 days post Dose 3

  from Month 7 up to Month 60

• The person-year incidence of HPV 6-, 11-, 16-, and 18-related disease (e.g., VIN1+ orAIN1+ or VAIN1+ and genital warts)

  from Month 7 up to Month 60

• Percentage of Participants Who Report at any Injection-site and Systemic Adverse Event 30 minutes post any vaccination

  30 minutes after any dose of vaccination

• Number of subjects with Adverse Events (AEs)

  From Day 0 to Month 30

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: Placebo

4vHPV Vaccine

EXPERIMENTAL

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) BIOLOGICAL

0.5 ml injection in 3 dosing regimen

4vHPV Vaccine

Placebo BIOLOGICAL

0.5 ml injection in 3 dosing regimen

Placebo

Eligibility Criteria

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

You may qualify if:

• (IF Non-compliance with criterion "\*" option, the visit WILL be rescheduled)
• Chinese women aged 18-45 who can provide legal identification and had a sexual life history;
• The subject fully understands the study procedures, understands the risks and benefits associated related this 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 regular follow-up visits according to the study protocol;
• \*axillary's temperature \<37.3℃ on the day of enrollment;
• Subjects have not received any form of cervical cancer screening, or have been received 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;
• When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml β-HCG), they were not in the lactation period, had no family planning from Day 0 to 30 days after receiving the third dose of the vaccine. Agree to continue to use effective contraception (including: oral contraceptives, injectable or embedded contraceptives, sustained-release topical contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.) from the day of enrollment to 30 days after the third season of vaccination. Safe-period contraception, in vitro ejaculation, and emergency contraception are unacceptable methods of contraception.

You may not qualify if:

• (IF Non-compliance with criterion "\*" option, the visit WILL be rescheduled)
• Blood pressure (BP) before the first dose of vaccination was higher than normal or increased (systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg);
• \* Subjects had fever symptoms (axillary's temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);
• History of severe side effect to previous vaccinations or History of severe allergies (e.g. Swelling of the mouth and throat, Dyspnea, Hypotension or Shock, Severe urticaria) to components of study vaccine (e.g. Histidine, Polysorbate, and Aluminium phosphate). 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;
• Subjects with compromised immune systemsor 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 Autoimmune thyroid disease （e.g. Hyperthyroidism，Thyroiditis/Subacute thyroiditis，or Hypothyroidism), and other Autoimmune diseases ;
• Previous or current have epilepsy, seizures (except febrile seizures in children) or convulsions, or mental diseases, with a family history of psychosis;
• Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
• Previous or current have severe liver, kidney and cardiovascular diseases, diabetic complications or malignant tumor;
• Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;
• Immunosuppressant or immunopotentiator 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) exceeding the recommended dosage in the directions or showing any signs of systemic exposure) or planning to receive such treatment between the day of the first dose and 30 days after the third dose of the vaccine;
• Received any immunoglobulin or blood product within 3 months prior to the first dose of vaccination, or plans to receive such product between the day of the first dose and 30 days after the third dose of the vaccine;
• \* An acute illness or an acute episode of a chronic illness within 3 days prior to vaccination, or use antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
• 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;
• \* Received inactivated/recombinant/DNA vaccines (Non-attenuated vaccines) within 14 days prior to enrollment, or attenuated live vaccines within 28 days prior to enrollment;
• 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;

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (1)

Yi M

Liuchow, Guangxi, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Condylomata Acuminata

Interventions

Vaccines, Synthetic

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; 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

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: October 12, 2022
• First Posted: October 18, 2022
• Study Start: December 9, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 21, 2023

Record last verified: 2022-10

Locations

CN (1)