NCT02740777

Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd · Industry
• Sex: Female
• Age: 9 Years – 24 Years
• Healthy volunteers: Accepted

Summary

To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

Detailed description

The study plans to enroll 600 adolescent females aged 9 to 14 years and 300 adult females aged 18 to 26 years. The adolescents will be divided into two cohorts, 300 each, receiving either a 2-dose (0, 6 months) immunization schedule or a 3-dose (0, 2, 6 months) immunization schedule. The adult female group will receive a 3-dose (0, 2, 6 months) immunization schedule. Each subject shall be administrated with the studied vaccine according to either 2-dose or 3-dose schedule as above. Immediate reactions occurred during 30 minutes after each inoculation, all the local and systematic reactions occurred from 0 to 7 days after each inoculation will be recorded. All the adverse events (AEs) occurred from the first dose of administration to 1 month after the final dose of administration, as well as all the serious adverse events (SAEs) occurred from the first dose of administration to 6 months after the final dose of administration will be collected. Blood samples will be collected at day 0 (prior to immunization) , month 6 (prior to the last injection) , month 7, month 12, month 24, and month 36. All the blood samples will be tested HPV 16- and HPV 18-specific antibody titers.

Conditions

• Human Papillomavirus
• Cervical Intraepithelial Neoplasia
• Persistent Infection

Interventions

Type	Name	Description
BIOLOGICAL	HPV-16/18 vaccine	HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-11-01
• Completion: 2019-07-01
• First posted: 2016-04-15
• Last updated: 2023-04-13

Locations

2 sites across 1 country: China