Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity

HPV Infection Clinical Trial

Official title: Two Domestic HPV Vaccines (Wozehui ® and Cecolin ®) and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity：A Multi-center Cohort Study in China

Status Not yet recruiting

Clinical Trial Summary

This is a multi-center, open, prospective cohort study that aims to investigate the immunogenicity and immune persistence of two different domestically produced bivalent HPV vaccines compared with an imported HPV vaccine in women aged 13-14 years. A total of 3,000 subjects who have completed 2 doses of the domestic bivalent HPV vaccine and 3 doses of the imported HPV vaccine will be recruited from Fujian Maternal and Child Health Hospital as the initiator of the study, and will be recruited from a number of healthcare institutions nationwide. Of these, 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Wozehui), 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Cecolin), and 1,000 subjects were vaccinated with the imported HPV vaccine. Each subject was enrolled within 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and a total of two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. In response to the WHO Cervical Cancer Elimination Strategy, domestic bivalent HPV vaccine has been offered free of charge to adolescent females aged 13-14 years, but there is still a lack of evidence comparing the antibody titer levels of domestic HPV vaccine and imported HPV vaccine in younger females. Therefore, we conducted the present immunogenicity study to explore the immunogenicity and immune persistence after vaccination with domestic bivalent HPV vaccine versus imported HPV vaccine in this age group of females.

Clinical Trial Description

The study aims to: 1) Evaluate the immunogenicity of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 years old; 2) Evaluate the immune persistence of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 years old. This study is a multi-center, open, prospective cohort study with a total of 3,000 subjects recruited. According to the HPV vaccine that the participants received in the previous period, they were divided into 1,000 people in the domestic bivalent HPV vaccine group (Wozehui), 1,000 people in the domestic bivalent HPV vaccine group (Cecolin), and 1,000 people in the imported HPV vaccine group. Three immuneogenic blood was collected in all subjects 30-60 days, 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of either the domestic bivalent HPV vaccine or the imported HPV vaccine, which was used to perform HPV type 16 and 18 neutralizing antibody testing. The aim of this study was to evaluate the immunogenicity difference between two different domestically produced bivalent HPV vaccines and imported HPV vaccines in adolescent females aged 13-14 years. ;

Related Conditions & MeSH terms

• HPV Infection
• HPV Vaccine
• Papillomavirus Infections

• NCT number: NCT06137352
• Study type: Observational
• Source: Fujian Maternity and Child Health Hospital
• Contact: Binhua Dong
• Phone: +86-591-87558732
• Email: dbh18-jy@126.com
• Status: Not yet recruiting
• Start date: December 15, 2023
• Completion date: December 31, 2026