Brief Title
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
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
Brief Summary
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.
Detailed Description
Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were
randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV)
vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The
women were actively monitored for adverse events for 1 month after each injection. Severe
adverse events during the trial were followed up. Serum samples from all the subjects would
be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and
immuno-persistency.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
Secondary Outcome
Number of Participants with Adverse Events
Condition
Cervical Intraepithelial Neoplasia
Intervention
30μg HPV
Study Arms / Comparison Groups
30μg HPV
Description: Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1600
Start Date
March 2011
Completion Date
October 2013
Primary Completion Date
December 2011
Eligibility Criteria
Inclusion Criteria:
- Written informed consent from the subject prior to enrolment;
- Female between, and including, 18 and 25 years of age at the time of enrolment;
- Subjects must be free of obvious health problems;
- Not pregnant and having no plan for pregnancy;
Exclusion Criteria:
- Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month
0-7);
- Previous vaccination against HPV;
- Having severe allergic history or other immunodeficiency;
- Chemotherapy and other immunosuppressive agents using;
Gender
Female
Ages
18 Years - 25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jun Zhang, Master, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01356823
Organization ID
HPV-PRO-002
Responsible Party
Principal Investigator
Study Sponsor
Xiamen University
Collaborators
Xiamen Innovax Biotech Co., Ltd
Study Sponsor
Jun Zhang, Master, Study Chair, Xiamen University
Verification Date
February 2014