NCT01356823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 5, 2016

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

May 13, 2011

Last Update Submit

January 3, 2016

Conditions

Cervical Intraepithelial NeoplasiaCervical Cancer

Keywords

Human Papilloma Virus 16Human Papilloma Virus 18vaccineCervical Intraepithelial Neoplasiacervical Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 months

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    7 months

Study Arms (4)

30μg HPV

EXPERIMENTAL

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

Biological: 30μg HPV

60μg HPV

EXPERIMENTAL

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

Biological: 60μg HPV

90μg HPV

EXPERIMENTAL

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

Biological: 90μg HPV

hepatitis B vaccine

PLACEBO COMPARATOR

Participants in this arm would receive hepatitis B vaccine.

Biological: Hepatitis B vaccine

Interventions

30μg HPVBIOLOGICAL

Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

30μg HPV
60μg HPVBIOLOGICAL

Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

60μg HPV
90μg HPVBIOLOGICAL

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

90μg HPV
Hepatitis B vaccineBIOLOGICAL

Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.

hepatitis B vaccine

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • 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.

    PMID: 26100924RESULT

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Interventions

Papillomavirus VaccinesHepatitis B Vaccines

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesViral Hepatitis Vaccines

Study Officials

  • Jun Zhang, Master

    Xiamen University

    STUDY CHAIR

  • Yuemei Hu, Bachelor

    Jiangsu Provincial Centre for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Ting Wu, Ph. D

    Xiamen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 20, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

October 1, 2013

Last Updated

January 5, 2016

Record last verified: 2014-02

Locations

CN(1)