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

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer
• Interventions: Biological: Hepatitis B vaccine; Biological: 60μg HPV; Biological: 30μg HPV; Biological: 90μg HPV

• Registration Number: NCT01356823
• Lead Sponsor: Xiamen University

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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-20
• Primary Completion: 2011-12
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hepatitis B vaccine	Hepatitis B vaccine	Participants in this arm would receive hepatitis B vaccine.
60μg HPV	60μg HPV	Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
30μg HPV	30μg HPV	Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
90μg HPV	90μg HPV	Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

Primary Outcome Measures

Name	Time	Method
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody	7 months	To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	7 months	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.

Trial Locations

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China