Chinese researchers have published 66-month follow-up data from a Phase III clinical study for the bivalent human papillomavirus (HPV) vaccine Cecolin, co-developed by Xiamen Innovax Biotech Co., Ltd and Xiamen University. The vaccine, approved in China since December 2019, demonstrated 100% protective efficacy against high-grade genital lesions associated with HPV 16/18 infection. The results, published in The Lancet Infectious Diseases, also showed that Cecolin effectively induced high-level antibodies for at least 5.5 years, with a good safety profile.
Study Details
The Phase III, double-blind, randomized, controlled trial was conducted at five sites in China. A total of 7,372 women aged 18-45 years were enrolled and randomly assigned to receive the HPV vaccine (n=3,689) or control (n=3,683). The study found that the vaccine efficacy was 100% (95% CI 67.2–100) against high-grade genital lesions and 97.3% (95% CI 89.9–99.7) against persistent infection in the per-protocol population. Serious adverse events occurred at a similar rate between the vaccine and control groups, with none considered related to vaccination.
Market Context
Cecolin passed the WHO Prequalification Program in October last year. Innovax is competing in China with GlaxoSmithKline’s bivalent vaccine (HPV16/-18), Walvax Bio’s bivalent (type 16/18) HPV vaccine, and Merck Sharp & Dohme’s tetravalent vaccine (HPV6/-11/-16/-18) and nine-valent vaccine (HPV6/-11/-16/-18/-31) /-33/-45/-52/-58).-Fineline Info & Tech
