Immunogenicity Assessment of a 14-Valent Human Papillomavirus Vaccine Candidate in Mice.

Background: Cervical cancer ranks as the fourth most common cancer affecting women globally, with HPV as the primary etiology agent. Prophylactic HPV vaccines have substantially reduced the incidence of cervical cancer.

Methods: This study assessed the immunogenicity of SCT1000, a 14-valent recombinant virus-like particle (VLP) vaccine developed by Sinocelltech, Ltd. using pseudovirion-based neutralization assays (PBNAs) and total IgG Luminex immunoassays (LIAs). Currently in phase III clinical trials in China, SCT1000 targets the same HPV types as Gardasil 9^®, plus five additional high-risk types, thereby covering twelve high-risk HPV types implicated in 96.4% of cervical cancer cases.

Results: In murine models, a dose of 1.85 μg per mouse was identified as optimal for evaluating SCT1000's immunogenicity in a three-dose regimen, as measured by PBNA and total IgG LIA across all 14 HPV types. SCT1000 induced high levels of protective antibodies, which were sustained for at least four months following the third dose. The vaccine also demonstrated stable and consistent immunogenicity in mouse potency assays under both long-term and accelerated conditions. Additionally, our studies revealed a strong correlation between the two serological tests used.

Conclusions: SCT1000 elicited robust, durable, and consistent humoral immune responses across all 14 HPV types, indicating its potential as a broad-spectrum vaccine candidate against HPV types 6/11/16/18/31/33/35/39/45/51/52/56/58/59. The significant correlations observed between PBNA and total IgG LIA support the use of the Luminex-based total IgG method as a reliable and effective alternative for immunogenicity assessment in preclinical and future clinical vaccine development.