A novel HPV mRNA vaccine candidate: immunogenicity and definition of immune correlates of protection
4 affiliations
- 1Department of Bio-Medical Science, GAIST, Gachon University
- 2Department of Microbiology, College of Medicine, Gachon University
- 3Department of Life Science, College of BioNano Technology, Gachon University
- 4Lee Gil Ya Cancer and Diabetes Institute, Gachon University
Abstract
Human papillomavirus (HPV), the major cause of cervical cancer, continues to be associated with an increasing number of diagnosed cases despite the availability of licensed vaccines such as Cervarix™ and GARDASIL ® . In addition, cervical cancer incidence remains especially high in low- and middle-income countries, while vaccine coverage remains low due to high costs and instability in supply. We developed a novel HPV vaccine candidate using mRNA platform and to propose immune correlates of protection (CoP) for efficacy evaluation. A protection threshold was established based on GARDASIL ® 9, and the corresponding antibody titers were determined. These antibody titers were used as Reference for the immunogenicity analysis of the generated HPV16 mRNA. As a result, the vaccine was shown to induce a sufficiently significant level of protective efficacy. Furthermore, based on the immunogenicity data obtained from GARDASIL ® 9 and HPV16 mRNA, the minimum antibody titers required for protection were determined, thereby defining CoP for HPV vaccine. Additionally, HPV16 mRNA induced cellular immune responses associated with CD4- and CD8-specific cytokine secretion, suggesting potential protective mechanism in which cellular immunity complements humoral immunity. This study proposes an objective evaluation framework for comparing and analyzing HPV vaccine efficacy across different vaccine platforms.
Related
- Safety and immunogenicity testing of a melioidosis subunit vaccine candidate in cynomolgus macaques
- Safety and immunogenicity of a first-generation modified vaccinia virus Ankara-vectored SARS-CoV-2 vaccine candidate with mRNA-based booster vaccination: A phase 1 trial.
- Correlates of Protection and Response Durability of the RTS,S Vaccine in Four Malaria Challenge Studies
- Immunogenicity and safety of Sabin inactivated poliovirus vaccine in a sequential schedule with bivalent oral poliovirus vaccine in Nepal: a single-centre, double-blind, randomised, controlled, non-inferiority trial
- 531 Phase I study to assess the safety, immunogenicity, and preliminary antitumor activity of the EBV mRNA vaccine (WGc-043 injection) in patients with R/R lymphoma
BibTeX
@article{hwang2026novel,
title = {{A novel HPV mRNA vaccine candidate: immunogenicity and definition of immune correlates of protection}},
author = {Hyogyeong Hwang and Timothy An and Eun-Hye Seo and Pil-Gu Park and Kee-Jong Hong},
journal = {Frontiers in Immunology},
year = {2026},
month = oct,
doi = {10.3389/fimmu.2026.1925901},
url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1925901/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - A novel HPV mRNA vaccine candidate: immunogenicity and definition of immune correlates of protection
AU - Hyogyeong Hwang
AU - Timothy An
AU - Eun-Hye Seo
AU - Pil-Gu Park
AU - Kee-Jong Hong
PY - 2026
DA - 2026/10/21
JO - Frontiers in Immunology
DO - 10.3389/fimmu.2026.1925901
UR - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1925901/full
AB - Human papillomavirus (HPV), the major cause of cervical cancer, continues to be associated with an increasing number of diagnosed cases despite the availability of licensed vaccines such as Cervarix™ and GARDASIL ® . In addition, cervical cancer incidence remains especially high in low- and middle-income countries, while vaccine coverage remains low due to high costs and instability in supply. We developed a novel HPV vaccine candidate using mRNA platform and to propose immune correlates of protection (CoP) for efficacy evaluation. A protection threshold was established based on GARDASIL ® 9, and the corresponding antibody titers were determined. These antibody titers were used as Reference for the immunogenicity analysis of the generated HPV16 mRNA. As a result, the vaccine was shown to induce a sufficiently significant level of protective efficacy. Furthermore, based on the immunogenicity data obtained from GARDASIL ® 9 and HPV16 mRNA, the minimum antibody titers required for protection were determined, thereby defining CoP for HPV vaccine. Additionally, HPV16 mRNA induced cellular immune responses associated with CD4- and CD8-specific cytokine secretion, suggesting potential protective mechanism in which cellular immunity complements humoral immunity. This study proposes an objective evaluation framework for comparing and analyzing HPV vaccine efficacy across different vaccine platforms.
SN - 1664-3224
ER -