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Updated: Jun 6, 2025
Evaluation of Host-Pathogen Responses and Vaccine Efficacy in Mice
Published on: February 22, 2019
Immunogenicity Assessment of a 14-Valent Human Papillomavirus Vaccine Candidate in Mice
Lei Bei1, Shuman Gao2, Dandan Zhao2
1Heilongjiang Pharmaceutical Research Institute, Jiamusi University, Jiamusi 154007, China.
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.
Insights
A new 14-valent HPV vaccine, SCT1000, shows robust and lasting antibody responses in mice. This broad-spectrum vaccine candidate offers potential against numerous high-risk HPV types, supporting cervical cancer prevention.
Area of Science:
- Immunology
- Vaccinology
- Oncology
Background:
- Cervical cancer is a leading global cancer in women, primarily caused by Human Papillomavirus (HPV).
- Prophylactic HPV vaccines have significantly decreased cervical cancer incidence.
- SCT1000 is a novel 14-valent VLP vaccine targeting 12 high-risk HPV types responsible for 96.4% of cervical cancers.
Purpose of the Study:
- To assess the immunogenicity of SCT1000, a 14-valent HPV vaccine.
- To evaluate antibody responses using pseudovirion-based neutralization assays (PBNAs) and total IgG Luminex immunoassays (LIAs).
- To determine the optimal dosage and assess the durability and consistency of the vaccine's immune response.
Main Methods:
- Utilized murine models to evaluate SCT1000 immunogenicity at a dose of 1.85 μg/mouse.
- Employed a three-dose vaccination regimen.
- Assessed antibody levels and durability using PBNA and total IgG LIA across all 14 targeted HPV types.
Main Results:
- SCT1000 induced high levels of protective antibodies against all 14 HPV types.
- Antibody responses were sustained for at least four months post-vaccination.
- Consistent immunogenicity was observed under various assay conditions, with a strong correlation between PBNA and LIA.
Conclusions:
- SCT1000 demonstrated robust, durable, and consistent humoral immune responses across all 14 HPV types.
- The vaccine shows potential as a broad-spectrum candidate against key HPV types linked to cervical cancer.
- The Luminex-based total IgG method is validated as a reliable alternative for immunogenicity assessment in vaccine development.
