Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent(Type 16/18 )Vaccine
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ClinicalTrials.gov Identifier: NCT01735006 |
Recruitment Status :
Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : July 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Intraepithelial Neoplasia Cervical Cancer Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia Persistent Infection | Biological: HPV Vaccine Biological: HEV vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7372 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | November 22, 2012 |
Estimated Primary Completion Date : | February 28, 2019 |
Estimated Study Completion Date : | February 28, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: HPV vaccine
This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
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Biological: HPV Vaccine
3 doses at month 0,1 and 6 |
Placebo Comparator: HEV vaccine
commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
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Biological: HEV vaccine
3 doses at month 0,1 and 6
Other Name: Hecolin |
- 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 ]
- Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ]
- Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after each vaccination ]
- Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Month 7 ]
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: expected 5-6 years ]
- number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 [ Time Frame: expected 5-6 years ]
- 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 ]
- number of subjects with incidence infection associated with HPV-16 and/or HPV-18 [ Time Frame: expected 2-3 years ]
- Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 [ Time Frame: month 7 ]
- 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).

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735006
China | |
Cancer Institute & Hospital Chinese Academy of Medical Sciences | |
Beijing, China, 100021 |
Study Chair: | Jun Zhang, Master | Xiamen University | |
Principal Investigator: | Youlin Qiao, Ph.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | |
Study Director: | Ting Wu, Ph. D | Xiamen University |
Responsible Party: | Jun Zhang, professor, Xiamen University |
ClinicalTrials.gov Identifier: | NCT01735006 History of Changes |
Other Study ID Numbers: |
HPV-PRO-003 |
First Posted: | November 28, 2012 Key Record Dates |
Last Update Posted: | July 19, 2018 |
Last Verified: | July 2018 |
Human Papillomavirus 16 Human Papillomavirus 18 vaccine Cervical Intraepithelial Neoplasia |
cervical Cancer Vaginal intraepithelial neoplasia Vulvar intraepithelial neoplasia |
Uterine Cervical Neoplasms Carcinoma in Situ Cervical Intraepithelial Neoplasia Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Vaccines Immunologic Factors Physiological Effects of Drugs |