Delving into the Latest Updates on Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Multivalent vaccine, Genetically engineered subunit vaccine

Synonyms

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesNervous System Diseases+ [4]

Active Indication

Acute Ischemic StrokeAnus NeoplasmsCondylomata Acuminata+ [4]

Inactive Indication-

Originator Organization

Sinocelltech Group Ltd.

Active Organization

Beijing Nuoning Biotechnology Co., Ltd.

Sinocelltech Group Ltd.

Shenzhou Cell Engineering Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective efficacy, safety and immunogenicity of a recombinant 14-valent human papillomavirus (HPV) vaccine (types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) (insect cells) in healthy females aged 18 to 45 years

与安慰剂比较，评价接种3剂HPV疫苗（SCT1000）在18-45周岁健康女性中预防HPV6,11,16,18,31,33,35,39,45,51,52,56,58,59型别相关病变的保护效力。

[Translation]

To evaluate the protective efficacy of three doses of HPV vaccine (SCT1000) compared with placebo in preventing HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59-related lesions in healthy women aged 18-45 years.

Start Date31 Aug 2023

Sponsor / Collaborator

Beijing Nuoning Biotechnology Co., Ltd.

[+1]

NCT06041061 / Active, not recruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years

A total of 18000 healthy women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 36-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Start Date13 Aug 2023

Sponsor / Collaborator

Sinocelltech Group Ltd.

[+2]

CTR20212245 / CompletedPhase 2

随机、双盲、阳性及安慰剂对照评价重组十四价人乳头瘤病毒疫苗（6,11,16,18,31,33,35,39,45,51,52,56,58,59型）（昆虫细胞）在18-45周岁健康女性人群中免疫原性和安全性的Ⅱ期临床试验

[Translation] A randomized, double-blind, positive and placebo-controlled phase II clinical trial to evaluate the immunogenicity and safety of recombinant 14-valent human papillomavirus vaccine (types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) (insect cells) in healthy females aged 18-45 years

评价SCT1000在18-45周岁健康女性人群中的免疫原性、安全性

[Translation]

To evaluate the immunogenicity and safety of SCT1000 in healthy females aged 18-45 years

Start Date19 Oct 2021

Sponsor / Collaborator

Beijing Nuoning Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech)

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100 Translational Medicine associated with Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech)

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100 Patents (Medical) associated with Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech)

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3

Literatures (Medical) associated with Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech)

01 Aug 2024·Journal of Medical Virology

Validation of a triple‐color pseudovirion‐based neutralization assay for immunogenicity assessment of a 14‐valent recombinant human papillomavirus vaccine

Article

Author: Xie, Liangzhi ; Lu, Jianbo ; Feng, Caixia ; Gao, Shuman ; Wang, Yang ; Li, Xuefeng ; Kou, Yajuan ; Zhao, Dandan ; Luo, Chunxia

AbstractValidation of bioanalytical methods is crucial, especially in the pharmaceutical industry, to determine their suitability for specific purposes and the accuracy of analytical results. The pseudovirion‐based neutralization assay (PBNA) is considered the gold standard for detecting and quantifying neutralizing antibodies against human papillomavirus in vaccine development for disease prevention. This paper introduces an improved triple‐color PBNA method, capable of simultaneous detection of two or three human papillomavirus (HPV types for use in the development of a 14‐valent HPV vaccine candidate. The primary objective was to comprehensively validate the triple‐color PBNA method for general vaccine immunogenicity assays. Results show that the method has good specificity, accuracy, precision, linearity, robustness, and applicability. This innovative triple‐color PBNA offers an improved approach for large‐scale immunogenicity assessment in vaccine development. This study lays a solid foundation that can serve as a guiding paradigm for assessing vaccine responses in preclinical and clinical phases, providing valuable insights to the field.

01 Aug 2023·Journal of Medical Virology

Validation of Luminex immunological and competitive Luminex immunological assays for clinical immunogenicity assessment of a 14‐valent recombinant human papillomavirus vaccine

Article

Author: Wang, Yang ; Zhang, Xiao ; Gai, Wenlin ; Meng, Dan ; Zhao, Chaonan ; Li, Jing ; Li, Xuefeng ; Hu, Ping ; Luo, Chunxia ; Li, Hong ; Gu, Weihua ; Zhao, Lu ; Xie, Liangzhi ; Wang, Rui

AbstractA novel virus‐like particle (VLP)‐based multivalent recombinant human papillomavirus (HPV) vaccine was developed and evaluated in human, including 14 HPV‐type specific VLP antigens (HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59). The pseudovirus‐based neutralizing assay (PBNA) method is widely used for immunogenicity assessment of HPV vaccine in clinical trials. However, as many as 14 antigen‐specific antibody levels need be determined, PBNA is, for many reasons, challenging and time‐consuming. In this study, we developed a Luminex immunological assay (LIA) and a competitive Luminex immunological assay (cLIA). These methods increase the throughput, reproducibility and precision, as well as reduce the complexity. All assay parameters showed good characteristics in the validation of both methods, benefiting from highly purified and structurally correct VLPs, high specific antibodies, standard VLP‐microspheres and PE‐mAbs conjugating process, adequate assay development and stable system. Validation data support the use of both methods for immunogenicity assessment in clinical trials. LIA showed higher sensitivity than cLIA, and due to limited epitopes of mAb, cLIA detected lower antibody responses, and therefore, fewer antibodies. This work not only supports clinical trials of 14‐valent HPV vaccines more efficiently and reliably, but also provides a set of validation strategies and usable standards for general vaccine immunogenicity testing.

01 Aug 2022·Journal of Medical VirologyQ4 · MEDICINE

Immunogenicity correlation in cynomolgus monkeys between Luminex‐based total IgG immunoassay and pseudovirion‐based neutralization assay for a 14‐valent recombinant human papillomavirus vaccine

Q4 · MEDICINE

Article

Author: Xie, Liangzhi ; Bei, Lei ; Meng, Dan ; Luo, Chunxia ; Zhang, Xiao ; Qiu, Hongbin ; Gao, Shuman ; Zhao, Dandan ; Li, Xuefeng ; Jia, Jilei

AbstractA new virus‐like particle based vaccine covering 14 types of high‐risk and disease‐inducing human papillomavirus (HPV) can offer better coverage against HPV‐induced diseases, particularly cervical cancers. However, the assessment of immunogenicity of the vaccine is an important task, representing not only its significant clinical characteristics, but also a major challenge, in terms of both the suitability of methods and the clinical sample testing throughput supporting clinical development. This work covers the development and evaluation of a method based on Luminex technology (a coded‐bead and flow‐cytometric approach) to assess the HPV‐type specific total immunoglobulin G (IgG). This method can evaluate the antibodies in sera post immunization against multiple types of HPV simultaneously (i.e., with multiplexing capability), save time and cost, and improve test throughput with higher sensitivity and precision than the classical, plate‐based enzyme‐linked immunoassay and competitive Luminex‐based immunoassays. Using cynomolgus monkeys as model, we demonstrated the good correlation between the results from the pseudovirion‐based neutralization assay (PBNA), and the Luminex‐based total IgG assay, supporting that the latter method can be considered as a viable, dependable replacement method for the PBNA supporting immunogenicity evaluation of HPV vaccine in preclinical development and clinical investigation.

100 Deals associated with Recombinant 14 valent Human Papillomavirus Vaccine14 valent HPV vaccine(Sinocelltech)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 3	CN	Beijing Nuoning Biotechnology Co., Ltd.	31 Aug 2023
Anus Neoplasms	Phase 3	CN	Beijing Nuoning Biotechnology Co., Ltd.	31 Aug 2023
Anus Neoplasms	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	31 Aug 2023
Condylomata Acuminata	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	31 Aug 2023
Condylomata Acuminata	Phase 3	CN	Beijing Nuoning Biotechnology Co., Ltd.	31 Aug 2023
Uterine Cervical Cancer	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	31 Aug 2023
Uterine Cervical Cancer	Phase 3	CN	Beijing Nuoning Biotechnology Co., Ltd.	31 Aug 2023
Vulvar Neoplasms	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	31 Aug 2023
Vulvar Neoplasms	Phase 3	CN	Beijing Nuoning Biotechnology Co., Ltd.	31 Aug 2023
Human Papillomavirus Infection	Phase 3	CN	Sinocelltech Group Ltd.	13 Aug 2023