NCT02733068

A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of HPV-16/18 Vaccine in Healthy Females Aged 18-30 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,000 (actual)
• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd · Industry
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.

Detailed description

This is a multi-centre, randomized, double blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent. This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each participants will received a three-dose schedule of vaccine or placebo randomly but with the proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. Blood samples will be collected before the first inoculation, and one month after the final injection, blood samples will also be collected in a group of participants containing 800 people to detect antibody titer. Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8 days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36, month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated, the participant will receive standard treatment and drop out from the study.

Conditions

• Human Papilloma Virus Infection Type 16
• Human Papilloma Virus Infection Type 18
• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	HPV-16/18 vaccine	0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
BIOLOGICAL	HPV-16/18 placebo	0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

Timeline

• Start date: 2014-11-02
• Primary completion: 2019-07-30
• Completion: 2020-01-16
• First posted: 2016-04-11
• Last updated: 2022-12-19