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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356823
• Other study ID #: HPV-PRO-002
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2011
• Last updated: January 3, 2016
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: October 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

Biological:
• 30µg HPV
Participants would intramuscularly receive 30µg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
• 60µg HPV
Participants would intramuscularly receive 60µg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
• 90µg HPV
Participants would receive 90µg HPV vaccines which contains 60µg HPV 16 antigen and 30µg HPV 18 antigen
• Hepatitis B vaccine
Participants would intramuscularly receive 10µg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.

Locations

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

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	7 months	Yes