Immunogenicity and safety of an <i>Escherichia coli</i>-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial.

ABSTRACT:

Background

Vaccination with prophylactic human papillomavirus (HPV) vaccines is one of the most effective measures to prevent cervical cancer and other related diseases. Here we aimed to evaluate the immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus (9vHPV) vaccine.

Method

We did a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial in healthy women aged 20-45 years. All eligible participants were randomly assigned (1:1:1) to receive 270 ug 9vHPV, 360 ug 9vHPV, or the control vaccine (Gardasil) with a 0-2-6-month schedule. Serum samples were collected at day 0 and month 7 to assess IgG and neutralizing antibodies (nAbs). For HPV 6/HPV 11/HPV 16/HPV 18, non-inferiority was identified for the lowe

SUBMITTER: Wei M 

PROVIDER: S-EPMC12661565 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature