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NCT Number: NCT01735006

Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Infection Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects between, and including, 18 and 45 years of age at the first vaccination;
  • Healthy subjects as established by medical history and history-oriented clinical examination;
  • Be able to understand and comply with the request of the protocol;
  • Without acute cervicitis;
  • Not pregnant;
  • Have intact cervix.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
  • Are using immunosuppressants;
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
  • Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
  • Fever;
  • Concurrently participating another clinical trial;
  • Has received vaccines against HPV 16/18 ;
  • Immunodeficient;
  • History of allergic disease;
  • Serious medical disorders;
  • Blood coagulation disorders;
  • Epilepsy;
  • Unable to comply with protocol due to the mental illness;
  • Visible Condyloma;
  • Pregnant or breast-feeding women;
  • vergins;
  • Have more than 4 sexual partners.

Treatment and study plan

HPV vaccine

Biological

3 doses at month 0,1 and 6

HEV vaccine

Biological

3 doses at month 0,1 and 6

Other names: Hecolin

Primary outcomes

  1. Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection

    Time frame: expected 5-6 years

  2. Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)

    Time frame: expected 2-3 years

Secondary outcomes

  1. Number of Subjects Reporting Solicited Local and General Symptoms

    Time frame: Within 7 days after each vaccination

  2. Number of Subjects Reporting Unsolicited Adverse Events

    Time frame: Month 7

  3. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: expected 5-6 years

  4. number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18

    Time frame: expected 5-6 years

  5. number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection

    Time frame: expected 5-6 years

  6. number of subjects with incidence infection associated with HPV-16 and/or HPV-18

    Time frame: expected 2-3 years

  7. Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7

    Time frame: month 7

Other outcomes

  1. Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types

    Time frame: expected 5-6 years

    Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR).

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
  • Ministry of Science and Technology of the People´s Republic of China
  • Xiamen Innovax Biotech Co., Ltd

Registry information

Official study title

A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2012
Registry last updated
Feb 24, 2020

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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