Delving into the Latest Updates on Poliovirus vaccine live (Beijing Tiantan Biological Products Company) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine

Synonyms

Trivalent conventional inactivated poliovirus vaccine Beijing Tiantan Biological Products Company, Trivalent types 1 2 and 3 oral poliovirus vaccine

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Poliomyelitis

Inactive Indication-

Originator Organization

Beijing Tiantan Biological Products Corp. Ltd.

Active Organization

Beijing Tiantan Biological Products Corp. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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To evaluate the safety and immunogenicity of Sabin poliomyelitis inactivated vaccine (Vero cells) by observing healthy infants at 2 months of age after vaccination; to evaluate the immunogenicity of Sabin poliomyelitis inactivated vaccine (Vero cells) after booster immunization in healthy children at 18 months of age.

Start Date09 Sep 2016

Sponsor / Collaborator

Beijing Tiantan Biological Products Corp. Ltd.

CTR20160341

/ CompletedPhase 2

不同剂量Sabin株脊髓灰质炎灭活疫苗（sIPV）在2月龄婴儿中进行基础免疫的安全性及免疫原性研究

[Translation] Study on the safety and immunogenicity of different doses of Sabin inactivated poliomyelitis vaccine (sIPV) for primary immunization in 2-month-old infants

通过2月龄婴儿接种疫苗后的观察，评价不同剂量Sabin株脊髓灰质炎灭活疫苗（Vero细胞）的安全性及免疫原性

[Translation]

To evaluate the safety and immunogenicity of different doses of Sabin strain inactivated poliomyelitis vaccine (Vero cells) by observing infants vaccinated at 2 months of age

Start Date29 Mar 2016

Sponsor / Collaborator

Beijing Tiantan Biological Products Corp. Ltd.

CTR20150691

/ Active, not recruitingPhase 1

不同剂量Sabin株脊髓灰质炎灭活疫苗（sIPV）接种成人、儿童和婴儿的安全性研究

[Translation] Safety study of different doses of Sabin inactivated polio vaccine (sIPV) in adults, children and infants

通过对2月龄及以上人群接种疫苗后的观察，评价Sabin株脊髓灰质炎灭活疫苗（Vero细胞）的安全性，并初步探索免疫原性。

[Translation]

The safety of Sabin strain inactivated poliomyelitis vaccine (Vero cells) was evaluated and its immunogenicity was preliminarily explored by observing people aged 2 months and above after vaccination.

Start Date14 Oct 2015

Sponsor / Collaborator

Beijing Tiantan Biological Products Corp. Ltd.

100 Clinical Results associated with Poliovirus vaccine live (Beijing Tiantan Biological Products Company)

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100 Translational Medicine associated with Poliovirus vaccine live (Beijing Tiantan Biological Products Company)

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100 Patents (Medical) associated with Poliovirus vaccine live (Beijing Tiantan Biological Products Company)

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61

Literatures (Medical) associated with Poliovirus vaccine live (Beijing Tiantan Biological Products Company)

01 Jan 2023·Chinese Medical Sciences Journal

Regulations for the Manufacture and Control of Live Poliovirus Vaccine: International Experience and China’s Path

Article

Author: Wu, Miao

The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.

01 Dec 2018·BMC Research Notes

Poliovirus excretion following vaccination with live poliovirus vaccine in patients with primary immunodeficiency disorders: clinicians’ perspectives in the endgame plan for polio eradication

Article

Author: Ashghar, Humayun ; ElMarsafy, Aisha ; Burns, Cara ; Nasr, Eman ; ElHawary, Rabab ; Galal, Nermeen M ; Farag, Noha H ; Iber, Jane ; Bassiouni, Laila ; Chen, Qi ; Mach, Ondrej ; Meshaal, Safaa

OBJECTIVEPrimary immunodeficiency (PID) patients are prone to developing viral infections and should not be vaccinated with live vaccines. In such patients, prolonged excretion and viral divergence may occur and they may subsequently act as reservoirs in the community introducing mutated virus and jeopardizing polio eradication. One hundred and thirty PID cases were included for poliovirus detection in stool with assessment of divergence of detected polioviruses from oral polio vaccine (OPV) virus. Clinical presentations of PID patients with detectable poliovirus in stool specimens are described.RESULTSSix PID patients (4.5%) had detectable vaccine-derived poliovirus (VDPV) excretion in stool specimens; of these, five patients had severe combined immunodeficiency (two with acute flaccid paralysis, one with meningoencephalitis and two without neurological manifestations), and one patient had X-linked agammaglobulinemia (paralysis developed shortly after diagnosis of immunodeficiency). All six case-patients received trivalent OPV. Five case-patients had type 2 immunodeficiency-related vaccine-derived polioviruses (iVDPV2) excretion; one had concomitant excretion of Sabin like type 3 virus and one was identified as iVDPV1 excretor. Surveillance for poliovirus excretion among PID patients is critical as these patients represent a potential source to reseed polioviruses into populations.

01 Mar 2018·VaccineQ3 · MEDICINE

Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan

Q3 · MEDICINE

Article

Author: Oberste, M Steven ; Sutter, Roland W ; Saleem, Ali Faisal ; Quadri, Farheen ; Mach, Ondrej ; Zaidi, Anita K M ; Yousafzai, Mohammad Tahir ; Weldon, William C ; Zaidi, Syed S ; Alam, Muhammad M ; Khan, Asia

BACKGROUNDOutbreaks of circulating vaccine derived polioviruses type 2 (cVDPV2) remain a risk to poliovirus eradication in an era without live poliovirus vaccine containing type 2 in routine immunization. We evaluated existing outbreak response strategies recommended by the World Health Organization (WHO) for control of cVDPV2 outbreaks.METHODSSeronegative children for poliovirus type 2 (PV2) at 22 weeks of life were assigned to one of four study groups and received respectively (1) one dose of trivalent oral poliovirus vaccine (tOPV); (2) monovalent OPV 2 (mOPV2); (3) tOPV together with a dose of inactivated poliovirus vaccine (IPV); or (4) mOPV2 with monovalent high-potency IPV type 2. Stool and blood samples were collected and assessed for presence of PV2 (stool) and anti-polio antibodies (sera).RESULTSWe analyzed data from 265 children seronegative for PV2. Seroconversion to PV2 was achieved in 48, 76, 98 and 100% in Groups 1-4 respectively. mOPV2 was more immunogenic than tOPV alone (p < 0.001); and OPV in combination with IPV was more immunogenic than OPV alone (p < 0.001). There were 33%, 67%, 20% and 43% PV2 excretors in Groups 1-4 respectively. mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).CONCLUSIONmOPV2 was a more potent vaccine than tOPV. Adding IPV to OPV improved immunological response; adding IPV also seemed to have shortened the duration of PV2 shedding. mIPV2 did not provide measurable improvement of immune response when compared to conventional IPV. WHO recommendation to use mOPV2 as a vaccine of first choice in cVDPV2 outbreak response was supported by our findings. Clinical Trial registry number: NCT02189811.

100 Deals associated with Poliovirus vaccine live (Beijing Tiantan Biological Products Company)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Poliomyelitis	Phase 3	China	Beijing Tiantan Biological Products Corp. Ltd.	28 Feb 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02434770 (CTgov)	Phase 3	Poliomyelitis	750	BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 (BBIBP bOPV Lot 1)	catktdaqdt(cyjxiyatgy) = swalapnotd rhakmxfamc (xkcpxcvreo, icqqygrius - jvvszajafz) View more	-	10 Mar 2020
				BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 (BBIBP bOPV Lot 2)	catktdaqdt(cyjxiyatgy) = atykblosei rhakmxfamc (xkcpxcvreo, tgoqcojqhu - ghudtwrbuq) View more