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Title:
STABLE PREPARATION OF HUMAN PAPILLOMAVIRUS VIRUS-LIKE PARTICLE VACCINE
Document Type and Number:
WIPO Patent Application WO/2022/152204
Kind Code:
A1
Abstract:
Provided is a stable preparation of a human papillomavirus virus-like particle vaccine. The stable preparation is composed of a human papillomavirus virus-like particle, a buffer solution, an osmotic pressure regulator, a surfactant and an aluminum adjuvant, wherein the components of the vaccine comprise HPV virus-like particles assembled by L1 proteins of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and one or more HPV virus-like particles assembled by L1 proteins of other pathogenic HPV types. The preparation can enhance the stability of the vaccine and prolong the validity period of the vaccine in an aqueous preparation.

Inventors:
LIU YAN (CN)
HU PING (CN)
CHANG XINRONG (CN)
Application Number:
PCT/CN2022/071782
Publication Date:
July 21, 2022
Filing Date:
January 13, 2022
Export Citation:
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Assignee:
SINOCELLTECH LTD (CN)
International Classes:
A61K39/12; A61K39/295; A61K39/39; A61P15/00; A61P31/20; A61P35/00
Domestic Patent References:
WO2021013060A12021-01-28
WO2021013062A12021-01-28
WO2021013063A12021-01-28
WO2021013067A12021-01-28
WO2021013069A12021-01-28
WO2021013070A12021-01-28
WO2021013071A12021-01-28
WO2021013072A12021-01-28
WO2021013073A12021-01-28
WO2021013075A12021-01-28
WO2021013076A12021-01-28
WO2021013077A12021-01-28
WO2021013078A12021-01-28
WO2021013079A12021-01-28
WO2001097840A12001-12-27
Foreign References:
CN102349996A2012-02-15
CN101245099A2008-08-20
CN2020102601W2020-07-17
Other References:
CHRISTENSEN, N. D. ET AL.: "Hybrid papillomavirus L1 molecules assemble into virus-like particles that reconstitute conformational epitopes and induce neutralizing antibodies to distinct HPV types.", VIROLOGY., vol. 291, no. 2, 20 December 2001 (2001-12-20), XP002280750, DOI: 10.1006/viro.2001.1220
JIN SHI: "Controlled Assembly of Human Papillomavirus Capsid Protein L1in Vitro", CHINESE DOCTORAL DISSERTATIONS FULL-TEXT DATABASE, 1 May 2015 (2015-05-01), pages 1 - 140, XP055775976
LI, Z. H. ET AL.: "Rational design of a triple-type human papillomavirus vaccine by compromising viral-type specificity.", NAT COMMUN., vol. 9, no. 1, 18 December 2018 (2018-12-18), XP055776002, DOI: 10.1038/s41467-018-07199-6
PIMIENTA ELSA, RODRÍGUEZ SANDRA, FANDO RAFAEL, SERRANO YUNIER, ORTEGA DARIÉN, PALENZUELA ARIEL, MARRERO KAREN: "Cloning and expression in Escherichia coli of the full-lengh and deletion variants of a human papillomavirus 18 L1 gene isolated from a Cuban patient", REVISTA CUBANA DE MEDICINA TROPICAL, vol. 71, no. 2, 1 January 2019 (2019-01-01), pages e301, XP055951381
M. SHANK-RETZLAFFF. WANGT. MORLEY ET AL.: "Correlation between Mouse Potency and In Vitro Relative Potency for Human Papillomavirus Type 16 Virus-Like Particles and Gardasil Vaccine Samples", HUMAN VACCINES, vol. 1, no. 5, pages 191 - 197, XP055815561, DOI: 10.4161/hv.1.5.2126
MICHAEL J. CAULFIELDLI SHISU WANG ET AL.: "Effect of Alternative Aluminum Adjuvants on the Absorption and Immunogenicity of HPV16 L1 VLPs in Mice", HUMAN VACCINES, vol. 3, no. 4, pages 139 - 146
Attorney, Agent or Firm:
RUNPING & PARTNERS (CN)
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