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HPV Vaccine

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Vaccine

Human Papilloma Virus (HPV) Vaccine

Human papillomavirus (HPV) consists of a group of 200 recognized viruses, which don’t affect most people. However, it’s common to be infected with high-risk ones and thus get genital warts or cancer.

These cancers can be prevented by prophylactic vaccination against HPV. For example, Gardasil, as the first HPV prophylactic vaccine to be approved, can protect against 4 types of HPV (6, 11, 16, and 18). And other five types (31, 33, 45, 52, and 58) can be prevented by Gardasil 9. The vaccines, intended to protect the initial HPV infection, can generate virus-neutralizing antibodies. In the United States, Gardasil has been replaced by Gardasil 9, which covers nine serotypes instead of four. The Gardasil and Gardasil 9 vaccines are all recombinant VLPs with L1-HPV epitopes. However, to offset the increased number of different co-formulated VLPs, Gardasil9 contains a larger number of total antigens than Gardasil.

Evidence has shown that licensed vaccines can defend against genital wart development and cervical precancerous, and their protection is expected to last for at least 4.5 years. However, the current challenges lie in the cost of marketed HPV vaccines in yeasts or insect expression systems.

Successful steps have been made recently in generating low-cost HPV vaccines in Escherichia coli (E. coli). Cecolin, a bivalent L1-HPV vaccine targeting HPV16 and HPV18, has been successfully expressed in E. coli and has shown high immunogenicity in pre-clinical and clinical studies. The NMPA approved the use of Cecolin in China on December 30, 2019. Moreover, Cecolin, the first Chinese-produced HPV vaccine, was prequalified by WHO in October 2021.

图片

Fig 1. Structure of Virus-Like Particles Assembled from the L1 Protein of Human Papillomavirus 16. Website: https://www.rcsb.org/structure/1DZL.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for HPV Vaccine
HPV Vaccine Pipelines

Generic name

Brand Name/Alternative name

Expression System

Originator/Manufacture

R&D stage

Recombinant Quadrivalent HPV Vaccine (Types 6, 11, 16, 18)

Gardasil, V-501, Silgard, 佳达修, ガーダシル

Yeast (Saccharomyces cerevisiae)

Merck & Co., Inc.

Approval

Recombinant Nine-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)

Gardasil9, V503, Gardasil 9, 佳达修 9, Silgard, シルガード

Yeast (Saccharomyces cerevisiae)

Merck & Co., Inc.

Approval

Recombinant Bivalent HPV vaccine

Cecolin, 馨可宁

E. coli

Innovax Biotech

Approval

Recombinant Bivalent HPV vaccine

沃泽惠

Yeast (Pichia pastoris)

Shanghai Zerun Biotech, Walvax Biotechnology

Approval

Recombinant Bivalent HPV vaccine

MEDI-517, GSK-580299, HPV-032, HPV-046, Cervarix, 希瑞适, サーバリックス, HPV-16/18 L1 VLP/AS04

Baculoviruses

GSK Plc

Approval

Recombinant 11-valent HPV vaccine

Pending Update

Yeast (Hansenula polymorpha)

Simoon Record Beijing

Phase III

Recombinant HPV 16 E7 fusion protein vaccine

VR-111

Pending Update

Shanghai Zerun Biotech, Walvax Biotechnology

Phase III

Recombinant 9-valent HPV vaccine

Pending Update

Yeast (Pichia pastoris)

Shanghai Zerun Biotech, Walvax Biotechnology

Phase III

Recombinant 9-valent HPV vaccine

REC 603, REC-603

Yeast (Hansenula polymorpha)

Jiangsu Recbio Biotechnology.

Phase III

Recombinant nine-valent HPV vaccine

Pending Update

E. coli

Beijing Health Guard Biotechnology, R-PHARM

Phase III

Recombinant Trivalent HPV vaccine

Pending Update

E. coli

Beijing Health Guard Biotechnology

Phase III

Recombinant Nine-valent HPV vaccine

Pending Update

E. coli

Innovax Biotech

Phase III

Recombinant Quadrivalent HPV Vaccine (Type 6, 11, 16, 18)

Pending Update

Yeast (Hansenula polymorpha)

Shanghai Bovax Biotechnology

Phase III

Recombinant Nine-valent HPV vaccine

Pending Update

Yeast (Hansenula polymorpha)

Shanghai Bovax Biotechnology

Phase III

Recombinant Tetravalent HPV vaccine (6,11,16,18)

Pending Update

Yeast (Hansenula polymorpha)

Chengdu Institute of Biological Products Co., Ltd

Phase III

Recombinant bivalent HPV vaccine

Pending Update

E. coli

Innovax Biotech

Phase II

Recombinant 14-valent HPV vaccine

SCT1000

Insect cell

Sinocelltech Group Limited

Phase II

Tetravalent HPV vaccine

Pending Update

Yeast (Pichia pastoris)

Shanghai Institute of Biological Products

Phase II

TVGV-1

(PE-E7-K3) fusion protein

E. coli

TheVax Genetics Vaccine

Phase II
Reference:

Cid R, Bolívar J. Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies. Biomolecules. 2021 Jul 21;11(8):1072. doi: 10.3390/biom11081072.

Mohsen MO, Bachmann MF. Virus-like particle vaccinology, from bench to bedside. Cell Mol Immunol. 2022 Sep;19(9):993-1011. doi: 10.1038/s41423-022-00897-8.

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