Journal
VACCINE
Volume 35, Issue 24, Pages 3222-3231Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2017.04.064
Keywords
Human papillomavirus; Genital watts; Bivalent vaccine; Escherichia coli; Virus-like particle; Antigenicity; lmmunogenicity
Categories
Funding
- Chinese government: National Natural Science Foundation [31670935]
- National Key Projects in Science and Technology [2015ZX09101034, 2014AA021302]
- Fujian Provincial Key Projects in Science and Technology [2014Y2004]
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Human papillomavirus (HPV)-6 and HPV11 are the major etiological causes of condylomata acuminate. HPV neutralization by vaccine-elicited neutralizing antibodies can block viral infection and prevent subsequent disease. Currently, two commercially available HPV vaccines cover these two genotypes, expressed by Saccharomyces cerevisiae. Here we describe another HPV6/11 bivalent vaccine candidate derived from Escherichia coli. The soluble expression of N-terminally truncated L1 proteins was optimized to generate HPV6- and HPV11 L1-only virus-like particles (VLPs) as a scalable process. In a pilot scale, we used various biochemical, biophysical and immunochemical approaches to comprehensively characterize the scale and lot consistency of the vaccine candidate at 30 L and 100 L. Cryo-EM structure analysis showed that these VLPs form a T = 7 icosahedral lattice, imitating the L1capsid of the authentic HPV virion. This HPV6/11 bivalent vaccine confers a neutralization titer and antibody production profile in monkey that is comparable with the quadrivalent vaccine, Gardasil. This study demonstrates the robustness and scalability of a potential HPV6/11 bivalent vaccine using a prokaryotic system for vaccine production. (C) 2017 Published by Elsevier Ltd.
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