NCT01263327

Brief Summary

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

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

December 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

December 17, 2010

Last Update Submit

July 9, 2020

Conditions

Cervical Cancer

Keywords

human papillomavirus vaccine

Outcome Measures

Primary Outcomes (1)

  • Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.

    7 months

Study Arms (1)

HPV 16/18

EXPERIMENTAL

Participants in this arm would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

Biological: HPV 16/18

Interventions

HPV 16/18BIOLOGICAL

Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

HPV 16/18

Eligibility Criteria

Age18 Years - 55 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 55 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

Dongtai, Jiangsu, 224200, China

Location

Related Publications (1)

  • Hu YM, Huang SJ, Chu K, Wu T, Wang ZZ, Yang CL, Cai JP, Jiang HM, Wang YJ, Guo M, Liu XH, Huang HJ, Zhu FC, Zhang J, Xia NS. Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial. Hum Vaccin Immunother. 2014;10(2):469-75. doi: 10.4161/hv.26846. Epub 2013 Oct 25.

    PMID: 24161937RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yue-mei Hu, Bachelor

    Jiangsu Provincial Centre for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 20, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

CN(1)