PF-D-Trimer, a protective SARS-CoV-2 subunit vaccine: immunogenicity and application

Autor: Zhihao Zhang, Jinhu Zhou, Peng Ni, Bing Hu, Normand Jolicoeur, Shuang Deng, Qian Xiao, Qian He, Gai Li, Yan Xia, Mei Liu, Cong Wang, Zhizheng Fang, Nan Xia, Zhe-Rui Zhang, Bo Zhang, Kun Cai, Yan Xu, Binlei Liu
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: npj Vaccines, Vol 8, Iss 1, Pp 1-13 (2023)
Druh dokumentu: article
ISSN: 2059-0105
DOI: 10.1038/s41541-023-00636-8
Popis: Abstract The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has had and continues to have a significant impact on global public health. One of the characteristics of SARS-CoV-2 is a surface homotrimeric spike protein, which is primarily responsible for the host immune response upon infection. Here we present the preclinical studies of a broadly protective SARS-CoV-2 subunit vaccine developed from our trimer domain platform using the Delta spike protein, from antigen design through purification, vaccine evaluation and manufacturability. The pre-fusion trimerized Delta spike protein, PF-D-Trimer, was highly expressed in Chinese hamster ovary (CHO) cells, purified by a rapid one-step anti-Trimer Domain monoclonal antibody immunoaffinity process and prepared as a vaccine formulation with an adjuvant. Immunogenicity studies have shown that this vaccine candidate induces robust immune responses in mouse, rat and Syrian hamster models. It also protects K18-hACE2 transgenic mice in a homologous viral challenge. Neutralizing antibodies induced by this vaccine show cross-reactivity against the ancestral WA1, Delta and several Omicrons, including BA.5.2. The formulated PF-D Trimer is stable for up to six months without refrigeration. The Trimer Domain platform was proven to be a key technology in the rapid production of PF-D-Trimer vaccine and may be crucial to accelerate the development and accessibility of updated versions of SARS-CoV-2 vaccines.
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