Delving into the Latest Updates on Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [3]

Active Indication

Anal intraepithelial neoplasiaHead and Neck NeoplasmsNeutropenia+ [9]

Inactive Indication-

Originator Organization

Beijing Health Guard Biotechnology, Inc.

Active Organization

Aihui Import and Export Process For Russia Heihe City Heilongjiang

Beijing Health Guard Biotechnology, Inc.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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评价重组三价 HPV 疫苗（16/18/58 型）接种于 18-45 岁中国女性人群的保护效力。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗（16/18/58 型）后可有效预防 HPV16、18 和 58 型别感染相关的高度宫颈异常（CIN 2/3）、原位腺癌（AIS）、浸润性宫颈癌、高级外阴上皮内瘤样病变（VIN 2/3）、高级阴道上皮内瘤样病变（VaIN 2/3）、外阴癌或阴道癌病变的发生。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗（16/18/58 型）后可有效预防 HPV16、18 和 58 型别相关的 12 个月持续感染（PI12）。

[Translation]

To evaluate the protective efficacy of recombinant trivalent HPV vaccine (type 16/18/58) in Chinese females aged 18-45 years. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent the occurrence of high-grade cervical abnormalities (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN 2/3), high-grade vaginal intraepithelial neoplasia (VaIN 2/3), vulvar cancer or vaginal cancer lesions associated with HPV16, 18 and 58 infection. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent 12-month persistent infection (PI12) associated with HPV16, 18 and 58.

Start Date17 Oct 2020

Sponsor / Collaborator

Taizhou Tiande Pharmaceutical Co., Ltd.

[+2]

CTR20180525 / CompletedPhase 2

在18-45岁健康女性受试者中进行的重组三价人乳头瘤病毒（16/18/58型）疫苗（大肠杆菌）单中心I/II期临床试验（第二部分）

[Translation] A single-center phase I/II clinical trial of a recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) in healthy female subjects aged 18-45 years (Part II)

在中国18-45岁健康女性中，评价不同剂量的重组三价人乳头瘤病毒16/18/58型疫苗（大肠杆菌）的安全性、耐受性和免疫原性

[Translation]

To evaluate the safety, tolerability, and immunogenicity of different doses of a recombinant trivalent human papillomavirus 16/18/58 vaccine (Escherichia coli) in healthy Chinese women aged 18-45 years

Start Date20 Oct 2018

Sponsor / Collaborator

Taizhou Tiande Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology)

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100 Translational Medicine associated with Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology)

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100 Patents (Medical) associated with Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology)

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1

Literatures (Medical) associated with Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology)

01 Jun 2017·Papillomavirus Research

A novel trivalent HPV 16/18/58 vaccine with anti-HPV 16 and 18 neutralizing antibody responses comparable to those induced by the Gardasil quadrivalent vaccine in rhesus macaque model

Article

Author: Zhang, Haijiang ; Yin, Fei ; Jiang, Dunquan ; Chen, Jianping ; Wang, Yan ; Yan, Mei ; Liu, Yongjiang ; Chen, Na ; Qiu, Yefeng ; Wang, Yajun

Persistent infection with human papillomavirus (HPV) is a key factor in the development of precancerous lesions and invasive cervical cancer. Prophylactic vaccines to immunize against HPV are an effective approach to reducing HPV related disease burden. In this study, we investigated the immunogenicity and dosage effect of a trivalent HPV 16/18/58 vaccine (3vHPV) produced in Escherichia coli (E.coli), with Gardasil quadrivalent vaccine (4vHPV, Merck & Co.) as a positive control. Sera collected from rhesus macaques vaccinated with three dosage formulations of 3vHPV (termed low-, mid-, and high-dosage formulations, respectively), and the 4vHPV vaccine were analyzed by both Pseudovirus-Based Neutralization Assay (PBNA) and Enzyme-Linked Immunosorbent Assay (ELISA). Strong immune responses against HPV 16/18/58 were successfully elicited, and dosage-dependence was observed, with likely occurrence of immune interference between different L1-VLP antigens. HPV 16/18 specific neutralizing antibody (nAb) and total immunoglobulin G (IgG) antibody responses in rhesus macaques receiving 3vHPV at the three dosages tested were generally non-inferior to those observed in rhesus macaques receiving 4vHPV throughout the study period. Particularly, HPV 18 nAb titers induced by the mid-dosage formulation that contained the same amounts of HPV 16/18 L1-VLPs as Gardasil 4vHPV were between 7.3 to 12.7-fold higher compared to the positive control arm from weeks 24-64. The durability of antibody responses specific to HPV 16/18 elicited by 3vHPV vaccines was also shown to be non-inferior to that associated with Gardasil 4vHPV.

100 Deals associated with Recombinant HPV-III(16/18/58) Vaccine(Beijing Health Guard Biotechnology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Persistent Infection	Phase 3	CN	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Persistent Infection	Phase 3	CN	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020
Vagina Carcinoma	Phase 3	CN	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Vagina Carcinoma	Phase 3	CN	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020
Vaginal intraepithelial neoplasia	Phase 3	CN	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Vaginal intraepithelial neoplasia	Phase 3	CN	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020
Vulvar intraepithelial neoplasia	Phase 3	CN	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020
Vulvar intraepithelial neoplasia	Phase 3	CN	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Vulvar Neoplasms	Phase 3	CN	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Vulvar Neoplasms	Phase 3	CN	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020