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A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

Primary Purpose

Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HPV-16/18 vaccine
HPV-16/18 placebo
Sponsored by
Shanghai Zerun Biotechnology Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus Infection Type 16

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-30 healthy female
  • enable to provide an legal identification
  • have the ability to understand and sign the Informed Consent Form
  • confirmed by the investigator that the participant has the ability to comply with the protocol requirements
  • agreed to use effective contraceptive method in 7 months or has no plan of pregnancy
  • can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection

Exclusion Criteria:

  • has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection
  • within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine
  • has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine
  • has a history of epilepsy, convulsion or has a family history of mental diseases
  • has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease
  • used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months
  • asplenia, functional asplenia, or splenectomize
  • liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor
  • coagulation disorders
  • in menstrual period or acute diseases
  • pregnant, or less than 8 weeks after delivery
  • has a history of sexual transmitted disease
  • had total hysterectomy or pelvic radiotherapy
  • has cervical abnormalities
  • abnormal screening results for cervical cancer or had CIN in two years
  • according to the judgement of investigator, participant has conditions that were not suitable for this trial
  • planning to move out of the clinical trial site during the research period
  • never has vaginal sexual activity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HPV-16/18 vaccine

    HPV-16/18 placebo

    Arm Description

    Including 6000 participants who received the HPV-16/18 vaccine 0.5ml.

    Including 6000 participants who received the HPV-16/18 placebo 0.5ml.

    Outcomes

    Primary Outcome Measures

    Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18.
    Among the 14 follow-up visits which will be conducted during the study, 9 visits are gynecological follow-up visits. In these gynecological visits, cervical samples will be collected to conduct HPV DNA detection and cytological detection to evaluate whether occurred cervical intraepithelial neoplasia (CIN) and what grade of neoplasia occurred.

    Secondary Outcome Measures

    Persistent infection of HPV type 16 and/or 18.
    Two continuously visits with a interval of 6 months indicate the same type of HPV infection can be regard as persistent infection.

    Full Information

    First Posted
    February 19, 2016
    Last Updated
    December 16, 2022
    Sponsor
    Shanghai Zerun Biotechnology Co.,Ltd
    Collaborators
    Guangxi Center for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02733068
    Brief Title
    A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
    Official Title
    A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of HPV-16/18 Vaccine in Healthy Females Aged 18-30 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2, 2014 (undefined)
    Primary Completion Date
    July 30, 2019 (Actual)
    Study Completion Date
    January 16, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zerun Biotechnology Co.,Ltd
    Collaborators
    Guangxi Center for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.
    Detailed Description
    This is a multi-centre, randomized, double blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent. This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each participants will received a three-dose schedule of vaccine or placebo randomly but with the proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. Blood samples will be collected before the first inoculation, and one month after the final injection, blood samples will also be collected in a group of participants containing 800 people to detect antibody titer. Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8 days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36, month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated, the participant will receive standard treatment and drop out from the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Cervical Intraepithelial Neoplasia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HPV-16/18 vaccine
    Arm Type
    Experimental
    Arm Description
    Including 6000 participants who received the HPV-16/18 vaccine 0.5ml.
    Arm Title
    HPV-16/18 placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Including 6000 participants who received the HPV-16/18 placebo 0.5ml.
    Intervention Type
    Biological
    Intervention Name(s)
    HPV-16/18 vaccine
    Intervention Description
    0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
    Intervention Type
    Biological
    Intervention Name(s)
    HPV-16/18 placebo
    Intervention Description
    0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
    Primary Outcome Measure Information:
    Title
    Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18.
    Description
    Among the 14 follow-up visits which will be conducted during the study, 9 visits are gynecological follow-up visits. In these gynecological visits, cervical samples will be collected to conduct HPV DNA detection and cytological detection to evaluate whether occurred cervical intraepithelial neoplasia (CIN) and what grade of neoplasia occurred.
    Time Frame
    five years
    Secondary Outcome Measure Information:
    Title
    Persistent infection of HPV type 16 and/or 18.
    Description
    Two continuously visits with a interval of 6 months indicate the same type of HPV infection can be regard as persistent infection.
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-30 healthy female enable to provide an legal identification have the ability to understand and sign the Informed Consent Form confirmed by the investigator that the participant has the ability to comply with the protocol requirements agreed to use effective contraceptive method in 7 months or has no plan of pregnancy can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection Exclusion Criteria: has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine has a history of epilepsy, convulsion or has a family history of mental diseases has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months asplenia, functional asplenia, or splenectomize liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor coagulation disorders in menstrual period or acute diseases pregnant, or less than 8 weeks after delivery has a history of sexual transmitted disease had total hysterectomy or pelvic radiotherapy has cervical abnormalities abnormal screening results for cervical cancer or had CIN in two years according to the judgement of investigator, participant has conditions that were not suitable for this trial planning to move out of the clinical trial site during the research period never has vaginal sexual activity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhaojun Mo
    Organizational Affiliation
    Guangxi Center for Disease Prevention and Control(GXCDC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

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