Long-term efficacy and immunopersistence of an <i>Escherichia coli</i>-produced HPV-16/18 bivalent vaccine: an observational extension study following a randomised, double-blind Phase III clinical trial cohort.

ABSTRACT:

Background

A safe and highly efficacious Escherichia coli-produced HPV-16/18 bivalent vaccine (Cecolin®) offers a cost-effective cervical cancer prevention measure. Here, we report data on the long-term efficacy and immunopersistence up to 10 years post-vaccination.

Methods

In the Phase III clinical trial (NCT01735006), 7372 women were enrolled and randomly assigned to receive the HPV or control vaccine (hepatitis E vaccine). Women from 2 sites (Xinmi City and Fengning County; N = 1986) were invited to participate in the extension study. Cervical samples were collected for ThinPrep Pap tests and HPV DNA testing. Serum samples from participants in the immune persistent subcohort (N = 300) were collected for neutralising antibody testing. The co-primary outcomes were hi

SUBMITTER: Zhao F 

PROVIDER: S-EPMC12396472 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature