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Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Primary Purpose

Cervical Intraepithelial Neoplasia, Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
30μg HPV
60μg HPV
90μg HPV
Hepatitis B vaccine
Sponsored by
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Intraepithelial Neoplasia focused on measuring Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • Jiangsu Provincial Centre for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

30μg HPV

60μg HPV

90μg HPV

hepatitis B vaccine

Arm Description

Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen

Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen

Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

Participants in this arm would receive hepatitis B vaccine.

Outcomes

Primary Outcome Measures

Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

Secondary Outcome Measures

Number of Participants with Adverse Events
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.

Full Information

First Posted
May 13, 2011
Last Updated
January 3, 2016
Sponsor
Xiamen University
Collaborators
Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01356823
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiamen University
Collaborators
Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Cervical Cancer
Keywords
Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30μg HPV
Arm Type
Experimental
Arm Description
Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
Arm Title
60μg HPV
Arm Type
Experimental
Arm Description
Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
Arm Title
90μg HPV
Arm Type
Experimental
Arm Description
Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Arm Title
hepatitis B vaccine
Arm Type
Placebo Comparator
Arm Description
Participants in this arm would receive hepatitis B vaccine.
Intervention Type
Biological
Intervention Name(s)
30μg HPV
Intervention Description
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Intervention Type
Biological
Intervention Name(s)
60μg HPV
Intervention Description
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Intervention Type
Biological
Intervention Name(s)
90μg HPV
Intervention Description
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
Intervention Description
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
Primary Outcome Measure Information:
Title
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
Description
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, Master
Organizational Affiliation
Xiamen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuemei Hu, Bachelor
Organizational Affiliation
Jiangsu Provincial Centre for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ting Wu, Ph. D
Organizational Affiliation
Xiamen University
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Provincial Centre for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26100924
Citation
Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19.
Results Reference
result

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Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

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