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Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HPV 16/18
Sponsored by
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring human papillomavirus vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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;

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 Type

Experimental

Arm Label

HPV 16/18

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2010
Last Updated
July 9, 2020
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
NCT01263327
Brief Title
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Official Title
An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
human papillomavirus vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPV 16/18
Arm Type
Experimental
Arm Description
Participants in this arm would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Intervention Type
Biological
Intervention Name(s)
HPV 16/18
Intervention Description
Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Primary Outcome Measure Information:
Title
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.
Time Frame
7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 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 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; 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
Yue-mei Hu, Bachelor
Organizational Affiliation
Jiangsu Provincial Centre for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Centre for Disease Control and Prevention
City
Dongtai
State/Province
Jiangsu
ZIP/Postal Code
224200
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24161937
Citation
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.
Results Reference
result

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Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

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