Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

NCT04895020 | Recruiting Phase 3

• 1 other identifier: 9-HPV-3003
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The primary immunogenicity objective

  The primary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the results of seroconversion rate of neutralizing antibodies after immunization in pre-immune negative subjects from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

  30 days after the last dose(3 doses schedule)

Secondary Outcomes (3)

• Number of patients with postive antibodies after the whole schedule vaccination from the former negative subjects

  30 days after the last dose(3 doses schedule)

• Rate of seroconversion among the patient aged 9-26 after the whole schedule vaccination

  30 days after the last dose(3 doses schedule)

• GMT and seropositive rate of HPV in the 9-19 age group after 60-month follow-up

  Day 1 to 60 months post vaccination 3

Other Outcomes (5)

• Number of AE within 30 minutes after each dose

  30 mins after each dose

• Number of SAE within 7days after each dose

  day 0 to day 7 after each dose

• Number of unsolicited adverse events within 30days after each dose

  day 0 to day 30 after each dose

Study Arms (1)

9-valent HPV vaccine

EXPERIMENTAL

9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

Biological: 9-valent HPV vaccine

Interventions

9-valent HPV vaccine BIOLOGICAL

9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

9-valent HPV vaccine

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy Chinese females aged 9 to 45 years; Provide legal identification;
• The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
• Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
• Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
• No fever symptoms on the day of enrollment (aged\> 14 years old, axillary temperature\<37.3°C; aged ≤ 14 years old, axillary temperature\<37.5°C );
• Received all 3 doses of trial vaccination;
• Subjects aged 9 to 19 years at the first stage.

You may not qualify if:

• Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
• History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, AIS, and cervical cancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), or history of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
• Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
• Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from day 0 to month 7 after the last dose;
• Had chronic diseases or congenital malformations, which might interfere with the process and completion of this study, such as Down Syndrome, heart diseases, liver diseases, chronic diabetes complications, and malignant tumor;
• Enrolling or plan to enroll in other clinical trials (drug or vaccine);
• Had infectious diseases such as TB, viral hepatitis, and/or HIV infection;
• Had convulsions, epilepsy, encephalopathy, and mental illness or family history;
• With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
• Asplenic, functionally asplenic, or splenectomy caused by any condition;
• Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
• Receipt of inactivated or recombinant vaccines within 14 days, live vaccines within 28 days;
• Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period;
• Had fever symptoms within 24 hours on the first day (aged\> 14 years old, axillary temperature ≥ 37.3°C; aged ≤ 14 years old, axillary temperature ≥37.5°C );
• Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP\>120mmHg and/or diastolic BP\>80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead
• Chongqing Bovax Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Huakun Lv

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

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

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; Vulvar Diseases; Vaginal Diseases; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Person(s) responsible for the overall scientific leadership of Lv

  Zhejiang Provincial Center for Disease Control and Prevention

  STUDY DIRECTOR

Central Study Contacts

Huakun Lv

CONTACT

13588458021; hklv@cdc.zj.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: May 28, 2021
• Primary Completion: January 13, 2023
• Study Completion: May 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (1)