Immunogenicity comparison of an <i>Escherichia coli</i>-produced 9-valent human papillomavirus vaccine and Gardasil9 in Chinese women aged 18-26 years: three-year follow-up data from a randomised clinical trial.

ABSTRACT:

Background

Cecolin9, a second-generation 9-valent HPV vaccine derived from the WHO-prequalified Cecolin, has received marketing authorisation in China in May 2025. The non-inferiority of type-specific immune responses between Cecolin9 and Gardasil9 has been previously established at month 7 in Chinese women aged 18-26 years (NCT04782895). This study aimed to compare the plateau antibody levels between the two vaccines three years post the first dose.

Methods

This was a prospective extension study of a randomised, single-blind trial conducted in China (ClinicalTrials.gov, NCT06197802). All the participants included in the base study were invited to participate in this extension. Blood samples were collected at year 3 (median follow-up time of 34 months) for neutralising antib

SUBMITTER: Zhong GH 

PROVIDER: S-EPMC12408396 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature