A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine

NCT05668572 | Unknown Phase 3 DMC

• 1 other identifier: KLWS-V502-03
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer or anal cancer.

Conditions

Human Papillomavirus Infection

Keywords

CIN 2/3; AIS; Invasive Cervical Carcinoma; VIN 2/3; VaIN 2/3; Anal Intraepithelial Neoplas

Outcome Measures

Primary Outcomes (2)

• The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade diseases

  The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer and anal cancer post 3 doses of the investigational vaccine as determined by histopathologic examination among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7 (composite end point)

  Up to 60th month after full immunization

• The combined incidence of specific HPV types related persistent infections for no less than 12 months and related diseases

  The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 12 months as determined by testing samples from consecutive visits, and cervical, vulvar, vaginal and anal diseases among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7.

  Up to 60th month after full immunization.

Secondary Outcomes (15)

• Overall incidence of adverse events post vaccination

  0-30 days after each immunization

• Overall incidence of adverse reactions post vaccination

  0-30 days after each immunization

• Incidence of adverse reactions by severity post vaccination

  0-30 days after each immunization

• Percentage of subjects with one or more injection-site or non-injection-site

  0-30 days after each immunization

• Incidence of adverse event/adverse reaction by sign/symptom post vaccination

  0-30 days after each immunization

Study Arms (2)

The Group of Investigational Vaccine

EXPERIMENTAL

Biological: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)

The Group of Active Control Vaccine

ACTIVE COMPARATOR

Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）

Interventions

Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) BIOLOGICAL

0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30mcg, 40mcg, 60mcg, 40mcg, 20mcg, 20mcg, 20mcg, 20mcg and 20mcg, respectively, totaling 270mcg of antigens. A 3-dose regimen administered at months 0, 2 and 6.

The Group of Investigational Vaccine

Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®） BIOLOGICAL

0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens

The Group of Active Control Vaccine

Eligibility Criteria

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

You may qualify if:

• Female subjects ages ≥20 and \<46 (i.e. 20-45 years of age).
• Subjects who voluntarily agree to participate in the trial by giving written informed consent, fully understand of study procedures and the risks associated with participating in the study, and are aware of alternative interventions are available for those who do not participate in the trial.
• Subjects who are able to read, understand, and complete the daily diary card.
• Subjects who are in a good physical health as decided by the investigator based on his/her medical history and physical checkup results.
• Subjects who have had sexual activity prior to enrollment.
• Subjects who have refrained from sexual activity (including anal, vaginal, or genital/genital contact whether same sex or opposite sex) and agree to refrain from douching/vaginal cleansing, and using vaginal medications or preparations for 48 hours prior to any visit that includes collection of study specimens.
• Subjects who are not pregnant (with negative urine pregnancy test) and breastfeeding at enrollment, and do not plan for pregnancy in the following 7 months; who have used effective contraception with no failures for 2 calendar days prior to the Day 0 visit (at enrollment), at the same time understand and agree that from Day 0 through Month 7, she shall not have sexual intercourse with males without effective contraception \[Effective contraception is defined as the use of a marketed, approved contraceptive product that includes oral contraceptives, contraceptive injections, sub-dermal contraceptive implants, slow-release systems, contraception-patches, intrauterine devices (IUD), sterilization, abstinence, male condoms, contraceptive diaphragms, cervical cap\].
• Subjects with an axillary temperature of 37.0 ℃ or less at enrollment.

You may not qualify if:

• Subjects who have received a marketed HPV vaccine, or have participated in an HPV vaccine clinical trial other than this one, or plan to receive an HPV vaccine other than the investigational vaccine or positive control during this study.
• Subjects who have a history of cervical cancer, CIN2+, HPV infections or an abnormal cytology result.
• Subjects who have a history of HPV-related external genital lesions (e.g. VIN, VaIN and genital warts), external genital cancer or vaginal cancer.
• Subjects who have a history of pelvic radiotherapy.
• Subjects who have had a recent history (within the last year) of drug or alcohol abuse or dependence.
• Subjects who have hypertension or diabetes mellitus despite being treated by medication.
• Subjects who have a history of severe allergic reaction (e.g. anaphylactic shock, laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.) to any prior vaccination or medication that required medical intervention.
• Subjects who are currently immunocompromised or have been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune conditions.
• Subjects who have had a splenectomy.
• Subjects who are receiving or have received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-α antagonists, monocolonal antibody therapies, intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with immune responses to the interventions.
• Subjects who are currently receiving systemic steroid therapy, or have received 2 or more courses of high dose systemic corticosteroids lasting at least 1 week in duration in the year prior to enrollment, with the exception of those who use inhaled, nasal, or topical corticosteroids.
• Subjects who have received any immune globulin product or blood-derived product within the 3 months prior to the first vaccination, or plan to receive any such product during the Day 0 through Month 7 period of the study.
• Subjects who have received inactivated vaccines within 14 days prior to the first vaccination or have received replicating (live attenuated) vaccines within 28 days prior to the first vaccination.
• Subjects who have thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
• Subject who have donated blood within 1 week prior to the first vaccination, or intend to donate during the Day 0 through Month 7 period of the study.

Sponsors & Collaborators

• Beijing Health Guard Biotechnology, Inc: lead

Study Sites (3)

CDC, Guangdong Provinc

Guangzhou, Guangdong, 510440, China

Location

CDC, Jiangsu Province

Nanjing, Jiangsu, 210009, China

Location

CDC, Shanxi Province

Taiyuan, Shanxi, 030012, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Papillomavirus Vaccines; Vaccines

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yongjiang Liu, Bachelor

  Beijing Health Guard Biotechnology, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor, investigators and biostatisticians will remain blinded to subject allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 30, 2022
• Study Start: December 5, 2020
• Primary Completion: July 21, 2022
• Study Completion: February 23, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)