A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China

NCT05662020 | Active Not Recruiting Phase 3

• 1 other identifier: KLWS-V502-04
• Study Type: interventional
• Target: 2,750
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.

Conditions

Human Papillomavirus Infection

Keywords

CIN; VIN; VaIN; AIN; Cervical cancer; Vaginal cancer; Vulvar cancer; Anal cancer, genital warts; Genital warts

Outcome Measures

Primary Outcomes (2)

• Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group

  Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.

  30 days after full immunization

• Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group

  Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group

  30 days after full immunization

Secondary Outcomes (12)

• Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group

  30 days after full immunization

• Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group

  30 days after full immunization

• GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects

  30 days after full immunization

• SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects

  30 days after full immunization

• GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination

  From the 12th month to 72nd month after first dose immunization

Study Arms (2)

The Group of Investigational Vaccine

EXPERIMENTAL

0.5 mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

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

0.5-mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

Biological: GARDASIL® 9

Interventions

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

9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.

The Group of Investigational Vaccine

GARDASIL® 9 BIOLOGICAL

20-26 years possitive control group will be vaccinated at months 0, 2 and 6

The Group of Active Control Vaccine

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female participants aged 9-26 years at the time of 1st dose vaccination (9 years ≤ age \< 27 years).
• Participants aged 9-17 years can provide proof of ID for themselves and their legal guardians, and the trustee (if appropriate) can provide proof of delegation and ID; participants aged 18-26 years can provide proof of their legal ID.
• If the female participant is of childbearing age: she must not be pregnant, must not be breastfeeding, and have negative urine pregnancy test before vaccination (on the day of vaccination); voluntarily agree to use effective contraception within 2 weeks prior to enrollment in the study; have no plans to have children and agrees to use effective contraception from the time of enrollment until 1 month after full vaccination.
• Participants whom have not reached menarche: If menarche occurs between enrollment and 1 month after full vaccination, subjects must agree to use effective contraception until 1 month after full vaccination. \[Effective contraceptive measures include: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, extended-release topical contraceptives, hormonal patches, intrauterine device (IUD), sterilization, abstinence, condoms (male), diaphragm, cervical cap, etc.\].
• The legal guardians or trustees of subjects of 9-17 years voluntarily signed the Informed Consent Form (ICF) with informed consent; Subjects of 9-17 years voluntarily signed the ICF for minors with informed consent; Subjects of 18-26 years voluntarily signed the ICF with informed consent.
• Participants and/or guardians are able to comply with the requirements of the clinical study protocol.

You may not qualify if:

• \* Fever (axillary temperature ≥ 37.3°C in participants \>14 years and ≥ 37.5°C in participants ≤14 years) within 24 hours prior to the 1st dose of vaccination.
• Previously vaccinated or have plans to administer other HPV vaccines during the study period.
• Plans to participate in other clinical studies during the study period or participate in other unfinished clinical trials within three months before participating in this clinical study; have used or plan to use other investigational or unregistered products (drugs or vaccines) within 28 days prior to 1st vaccination of this study vaccine.
• History of HPV positive, history of cervical lesions (e.g., abnormal cervical cancer screening results, history of abnormal cervical biopsy results, including cervical intraepithelial neoplasia (CIN), cervical low grade squamous intraepithelial lesions (LSIL), adenocarcinoma in situ or cervical cancer), history of HPV infection or abnormal cytology test or history of pelvic radiation therapy.
• History of anogenital disease associated with HPV infection (e.g., genital warts, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), anal intraepithelial neoplasia and associated carcinoma, etc.); or history of STDs (including syphilis, gonorrhea, genital chlamydia, genital herpes, soft chancre, lymphogranuloma venereum, inguinal sarcoidosis, etc.).
• Abnormalities of grade 1 or higher in the laboratory tests specified in this protocol, confirmed by clinician to be clinically significant (only applicable to the 20 subjects enrolled first in group B during the 1st stage).
• Allergy to any component of the study vaccine (including aluminum hydroxide adjuvant, sodium chloride, histidine, polysorbate, etc.) or previous serious adverse events to vaccination; previous history of serious allergy, including anaphylaxis, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), severe urticaria, respiratory distress, angio neuroedema, etc.
• Participants with an impaired immune system or who have been diagnosed with an innate or acquired immune deficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease.
• Epilepsy, excluding febrile convulsions under 2 years of age, or alcoholic epilepsy 3 years prior to abstinence from alcohol, or simple epilepsy not requiring treatment in the past 3 years.
• Current severe liver or kidney disease, serious cardiovascular disease, diabetes, malignancy, serious infectious disease (e.g., tuberculosis, HIV infection, etc.)
• Untreated/uncontrolled hypertension (systolic blood pressure \> 120 mmHg and/or diastolic blood pressure \> 80 mmHg) prior to vaccination for age 9-17 years; untreated/uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) prior to vaccination for age 18 years and older.
• Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiency, coagulopathies, platelet abnormalities) or clotting disorders
• Absence of spleen, asplenia, and any condition resulting asplenia or splenectomy.
• Participant has received immunosuppressive therapy within 1 month prior to vaccination or is scheduled to receive such therapy during the visit from the 1st dose to 30 days after full vaccination; e.g., long-term systemic glucocorticoid therapy (≥2 mg/kg/day for 2 weeks or more, e.g., prednisone or equivalent); topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are allowed.
• Have received immunoglobulin products or blood-related products within 3 months prior to the 1st dose, or plan to use such products during visits between the 1st dose and 30 days after full vaccination.

Sponsors & Collaborators

• Beijing Health Guard Biotechnology, Inc: lead
• Yunnan Center for Disease Control and Prevention: collaborator
• Mile City Center for Disease Control and Prevention: collaborator
• Qiubei County Center for Disease Control and Prevention: collaborator
• Yanshan County Center for Disease Control and Prevention: collaborator
• National Institutes for Food and Drug Control, China: collaborator
• Shanghai Stem Pharmaceutical Development Co., Ltd.: collaborator

Study Sites (1)

Yunnan Center for Disease Prevention and Control

Kunming, Yunnan, 650022, China

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Anus Neoplasms; Condylomata Acuminata

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; 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; Vaginal Diseases; Vulvar Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

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

Model Details: A total of 2,750 participants were enrolled in this study: 9-14 years (2 doses) group was administrated with investigational vaccine on 0 Day, 6th month, and 9-19 years (3 doses) group was administrated with investigational vaccine on 0 Day, 2nd month and 6th month. Both of these two group are of non-randomized, open label design; 20-26 years (3 doses) group was randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control, respectivelyon 0 Day, 2nd month and 6th month.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 22, 2022
• Study Start: March 23, 2022
• Primary Completion: November 7, 2022
• Study Completion (Estimated): March 23, 2028
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)