A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years

NCT06041061 | Active Not Recruiting Phase 3

• 1 other identifier: SCT1000-03
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 5

Brief Summary

A total of 18000 healthy women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 36-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Conditions

HPV InfectioN; HPV-Related Carcinoma

Keywords

HPV; Vaccine

Outcome Measures

Primary Outcomes (3)

• Combined Incidence of HPV Type 16/18-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer

  The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 16/18 by Polymerase Chain Reaction (PCR) assay for virus subtype.

  1 month after 3 doses of vaccine

• Combined Incidence of HPV Type 31/33/45/52/58-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer

  The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 31/33/45/52/58 by Polymerase Chain Reaction (PCR) assay for virus subtype.

  1 month after 3 doses of vaccine

• Combined Incidence of HPV Type 35/39/51/56/59-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer

  The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 35/39/51/56/59 by Polymerase Chain Reaction (PCR) assay for virus subtype.

  1 month after 3 doses of vaccine

Secondary Outcomes (20)

• Incidence of 6-month Persistent Infection associated with HPV types 16/18

  1 month after 3 doses of vaccine

• Incidence of 12-month Persistent Infection associated with HPV types 16/18

  1 month after 3 doses of vaccine

• Incidence of 6-month Persistent Infection associated with HPV types 31/33/45/52/58

  1 month after 3 doses of vaccine

• Incidence of 12-month Persistent Infection associated with HPV types 31/33/45/52/58

  1 month after 3 doses of vaccine

• Incidence of 6-month Persistent Infection associated with HPV types 35/39/51/56/59

  1 month after 3 doses of vaccine

Study Arms (2)

experiment group

EXPERIMENTAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

Biological: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）

placebo

PLACEBO COMPARATOR

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Biological: placebo

Interventions

Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell） BIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

experiment group

placebo BIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

placebo

Eligibility Criteria

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

You may qualify if:

• \. Females who are at least 18 years old and less than 46 years old (i.e., 18 to 45 years old).
• \. Subjects sign a written informed consent form (ICF) to participate in the trial voluntarily, and are able to fully understand the trial procedures, the risks of participating in the trial, and the alternative interventions available to them if they do not participate in the trial.
• \. Be able to read, understand and complete the diary/contact card. 4. Be in good health as judged by the history interview and physical examination.
• \. Have a history of sexual behavior prior to enrollment. 6.\*Avoid sexual intercourse (including same-sex or opposite-sex anal, vaginal, or genital/genital contact) and avoid vaginal douching, vaginal cleansing, or the use of vaginal medications or preparations for 48 hours prior to any visit that includes sample collection.
• \. Subjects who are not breastfeeding at the time of enrollment and who have used effective contraception from the time of their last menstrual period until enrollment in the study, and who understand and agree to use effective contraception from the first day of enrollment until 1 month after the last vaccination.
• \* Those with axillary body temperature \<37.3°C on the day of enrollment. 9. Note: Subjects who do not meet the \*enrollment criteria are allowed to be screened again, but the enrollment criteria still need to be confirmed again at the time of enrollment.

You may not qualify if:

• \. \*Positive urine pregnancy test or pregnancy (including ectopic pregnancy) that has ended less than 6 weeks ago.
• \. Prior vaccination with a marketed HPV vaccine or already enrolled in a clinical trial of another HPV vaccine or have plans to receive a non-study HPV vaccine during the study period.
• \. Have a prior history of cervical cancer screening abnormalities or lesions \[including HPV DNA positivity, squamous intraepithelial lesions (SIL) or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells-without the exception of high grade squamous intraepithelial lesions (ASC-H), atypical glandular cells (AGC), or have cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS) or cervical cancer\]. ) or cervical cancer, etc.\].
• \. Previous or current anal or genital disease (e.g. vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar, vaginal, and anal cancers) 5. Previous total hysterectomy or pelvic radiation therapy or severe developmental abnormalities of the cervix/vagina.
• \. History of drug or alcohol abuse or dependence in the last year. 7. Have hypertension or diabetes mellitus that cannot be controlled and stabilized with pharmacological interventions.
• \. Subjects with a history of severe allergic reactions to any vaccine or medication requiring medical intervention (e.g., anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction \[Arthus reaction\], etc.).
• \. Currently immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, tuberculosis, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease.
• \. Previous splenectomy or impaired splenic function. 11. Currently receiving or have received the following immunosuppressive therapies in the last year: radiation therapy, cyclophosphamide, imidazathioprine, methotrexate, as well as chemotherapy, cyclosporine, leflunomide, tumor necrosis factor-alpha antagonists, monoclonal antibody therapies, intravenous gammaglobulin, anti-lymphocytic serums, or other therapies that are known to interfere with immunity 12. Current treatment with systemic corticosteroids or 2 or more courses of high-dose glucocorticoids lasting one week in the year prior to enrollment. The use of nasal inhaled glucocorticoids or topical short-term topical application on the skin may not be excluded.
• \. Receipt of any immunoglobulin product or blood product within 3 months prior to vaccination, or planning to receive such similar products during the study period from Day 1 to Month 7.
• \. \* Inactivated/recombinant/nucleic acid vaccine, etc. (non-attenuated) within 14 days prior to vaccination or live attenuated vaccine within 28 days prior to vaccination.
• \. Contraindication to intramuscular injection such as thrombocytopenia or other coagulation disorders.
• \. \*Blood donation within 1 week prior to vaccination or planning to donate blood between Day 1 and Month 7 of study participation.
• \. Participation in other experimental clinical studies or studies with unregistered products (drugs or vaccines) or collection of cervical specimens within 3 months prior to vaccination.
• \. Inability to follow trial procedures or planned relocation during the study.
• \. \*Fever (axillary temperature ≥37.3°C) within 3 days prior to vaccination or any acute illness requiring systemic antibiotic or antiviral therapy within the past 5 days.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead
• Guangxi Center for Disease Control and Prevention: collaborator
• Henan Center for Disease Control and Prevention: collaborator
• Sichuan Center for Disease Control and Prevention: collaborator
• Centers for Disease Control and Prevention, China: collaborator
• Yunnan Center for Disease Control and Prevention: collaborator

Study Sites (5)

Guangxi Center for Disease Control and Prevention

Nanning, Guangxi, China

Location

Henan Center for Disease Control and Prevention

Zhengzhou, Henan, China

Location

Shanxi Center for Disease Control and Prevention

Taiyuan, Shanxi, China

Location

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China

Location

Yunan Center for Disease Control and Prevention

Kunming, Yunan, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

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

Study Officials

• Yi Mo

  Guangxi Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Yan Zheng

  Yunnan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Guohua Li

  Centers for Disease Control and Prevention, China

  PRINCIPAL INVESTIGATOR

• Ting Huang

  Sichuan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Zhiqaing Xie

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinds for randomized subjects and drug coding blinds will be generated and stored by an independent third party. Immunogenic subgroup blind maintenance: The subgroup information shall not be disclosed to the testing personnel. The serological test results report of the immunogenic subgroup shall be received by non-blind personnel independent of the project team, and the personnel designated by the data management unit shall be responsible for checking the blind data. Before the study is unblinded, the serum results should not be disclosed to the relevant personnel to ensure the blindness of serological test results. In order to ensure the implementation of the blind method, iDMC will be established in this experiment. At the time of the interim analysis, iDMC was responsible for completing the primary efficacy markers and safety assessment, while the sponsors, investigators, and project staff of the trial remained blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Recombinant 14-Valent Human Papillomavirus Vaccine (Types 6,11,16,18,31,33,35,39, 45,51,52,56,58,59) （Insect Cell）

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: September 18, 2023
• Study Start: August 13, 2023
• Primary Completion: March 1, 2024
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)