Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial.

ABSTRACT:

Background

Human papillomavirus (HPV) vaccines have been available for nearly 20 years. However, the overall coverage of girls aged 15 years and younger is low, especially in low-resource settings, where the burden of cervical cancer is highest. Increasing access and facilitating implementation of HPV vaccination will contribute to cervical cancer elimination efforts. To generate data in different dosing regimens and in low-resource settings, we aimed to evaluate the safety and immunogenicity of various schedules of an Escherichia coli-expressed bivalent HPV vaccine (2vHPV) compared with a widely used quadrivalent vaccine.

Methods

This randomised, controlled, open-label, non-inferiority, phase 3 trial enrolled healthy girls aged 9-14 years from single sites in Ghana and Bang

SUBMITTER: Agbenyega T 

PROVIDER: S-EPMC12287245 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature