NCT01356823

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,600 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Cancer

Interventions

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

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-12-01
• Completion: 2013-10-01
• First posted: 2011-05-20
• Last updated: 2016-01-05

Locations

1 site across 1 country: China