Single-dose trial interim analysis shows Wantai's Cecolin 9 beats Gardasil 9 on antibodies against 7 high-risk HPV types

The domestically developed 9-valent HPV vaccine Cecolin 9 (Xiamen Innovax/Wantai Biological) has entered a stage where commercialization and clinical evidence advance in parallel. The vaccine was licensed in China in May 2025 and covers the same nine HPV genotypes as Merck's Gardasil 9 [Industry Media·E]; its Phase III clinical data show a favorable safety profile, clear immunogenicity, and high protective efficacy against vaccine-targeted HPV types [Industry Media·C]. In addition, a lot-to-lot consistency clinical trial of the vaccine is underway, planning to enroll 720 participants, with the primary endpoint being the geometric mean concentrations (GMCs) of neutralizing antibodies to HPV6/11/16/18/31/33/45/52/58 one month after full vaccination (Month 7), sponsored by Xiamen Innovax Biotech Co., Ltd .

The key facts of this news: at the 38th International Papillomavirus Conference (IPVS 2026) held in Athens, Greece, PATH (Program for Appropriate Technology in Health, USA) presented 6-month interim results from an international Phase III multicenter clinical study evaluating a single-dose schedule of the 9-valent HPV vaccine. The data show that in young women aged 9-20 who received a single dose of the domestic Wantai 9-valent HPV vaccine Cecolin 9, the IgG geometric mean concentrations (GMCs) against 7 high-risk oncogenic HPV types were all significantly higher than Merck's Gardasil 9, with overall comparable safety. According to concurrent reports, the study is a Phase III, double-blind, randomized, multinational study in Ghana and the Philippines comparing the immunogenicity and safety of a single-dose schedule [Industry Media·G].

Relative to existing materials, these results advance Cecolin 9's evidence chain from the same-manufacturer Phase III and lot-to-lot consistency studies to a head-to-head comparison with the imported 9-valent vaccine under a single-dose schedule. A randomized blinded trial launched in 2023 had already compared the immunogenicity of the E. coli-produced 9-valent HPV vaccine with Gardasil 9 at a non-inferiority margin of -5% [Industry Media·F]; this interim analysis further shows that under a single-dose schedule the IgG GMCs for 7 high-risk types were significantly higher than the comparator, and the disclosure was led by PATH, an international public health organization, providing new comparative evidence for the domestic 9-valent vaccine in the single-dose scenario, a key setting for global cervical cancer elimination strategies (needs verification).

Undisclosed information includes: the exact enrollment number of the head-to-head study, the specific GMC values and confidence intervals by type, follow-up duration and final analysis timing, and whether and when the single-dose schedule will be submitted for regulatory approval—all pending confirmation. Follow-ups to watch include full data publication of this study, longer-term follow-up results, and regulatory and market progress in additional countries (needs verification).