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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263327
• Other study ID #: HPV-PRO-001
• Status: Completed
• Phase: Phase 1
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2020
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Provincial Centre for Disease Control and Prevention	Dongtai	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

References & 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-la — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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