Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
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|ClinicalTrials.gov Identifier: NCT01356823|
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : January 5, 2016
This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.
The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.
The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia Cervical Cancer||Biological: 30μg HPV Biological: 60μg HPV Biological: 90μg HPV Biological: Hepatitis B vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||October 2013|
Experimental: 30μg HPV
Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
Biological: 30μg HPV
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Experimental: 60μg HPV
Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
Biological: 60μg HPV
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Experimental: 90μg HPV
Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Biological: 90μg HPV
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Placebo Comparator: hepatitis B vaccine
Participants in this arm would receive hepatitis B vaccine.
Biological: Hepatitis B vaccine
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
- Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody [ Time Frame: 7 months ]To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
- Number of Participants with Adverse Events [ Time Frame: 7 months ]All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.
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): NCT01356823
|Jiangsu Provincial Centre for Disease Control and Prevention|
|Nanjing, Jiangsu, China, 210009|
|Study Chair:||Jun Zhang, Master||Xiamen University|
|Principal Investigator:||Yuemei Hu, Bachelor||Jiangsu Provincial Centre for Disease Control and Prevention|
|Study Director:||Ting Wu, Ph. D||Xiamen University|