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NCT Number: NCT05371353

Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

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Key information

Conditions

HPV Infections CIN1 CIN2 CIN3 Cervical Cancer Stage IIa Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Wart Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Virus Diseases Warts

Age range

9 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Yangchun Center For Disease Prevention And Control, Yangchun, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
  • The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
  • 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.

Exclusion criteria

  • Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
  • Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
  • According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Treatment and study plan

Primary outcomes

  1. Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 12

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

  2. SCR for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 24

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

  3. SCR for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 36

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

  4. SCR for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 48

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

  5. SCR for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 60

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

  6. Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 12

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

  7. GMTs for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 24

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

  8. GMTs for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 36

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

  9. GMTs for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 48

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

  10. GMTs for Each of the HPV Types Contained in the Vaccine

    Time frame: Month 60

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

Study contacts

Contact information is provided by the study sponsor or research team.

Jikai Zhang

CONTACT

[email protected]

020-89020236

Sponsors and collaborators

Lead sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Industry

Registry information

Official study title

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 12, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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