Delving into the Latest Updates on Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Polio Sabin

Target-

Mechanism-

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Poliomyelitis

Inactive Indication

Streptococcal Infections

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine, and for comparison with any potential new polio vaccine with a type 2 component in the future.

Start Date01 Oct 2015

Sponsor / Collaborator

Fidec SAS

[+1]

NCT01175083

/ CompletedPhase 3

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Start Date01 Jun 2011

Sponsor / Collaborator

GSK Plc

NCT01231503

/ CompletedPhase 2

Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa

The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
Investigate how to maximize the antibody response to the experimental malaria vaccine.

Start Date13 Jan 2011

Sponsor / Collaborator

GSK Plc

[+1]

100 Clinical Results associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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385

Literatures (Medical) associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

01 Feb 2024·Vaccine

Safety of incidental exposure to the novel oral poliovirus vaccine type 2 in pregnancy: A longitudinal observational study in Mozambique, 2022–2023

Article

Author: Bauhofer, Adilson ; Barata, Américo ; Lopez Cavestany, Rocio ; Jeyaseelan, Visalakshi ; Chissaque, Assucênio ; Jani, Ilesh Vinodrai ; de Deus, Nilsa ; Mach, Ondrej

BACKGROUNDTo minimize the risk of vaccine-derived poliovirus emergences, the novel oral poliovirus vaccine type 2 (nOPV2), was bioengineered to have increased genetic stability compared to Sabin OPV and recommended for outbreak response Emergency Use Listing by WHO. Although pregnant women are not a target population for this vaccine, a theoretical risk of incidental exposure exists via pharyngeal or faecal shedding from vaccinated children in the household or close community.METHODSThis was an observational study of pregnant women conducted in Nampula (exposed cohort) and Maputo (non-exposed cohort) in Mozambique from August 2022 to June 2023. Two nOPV2 campaigns were conducted in Nampula and none in Maputo. Women were followed-up during routine prenatal consultation, delivery, and 28-day neonate visits for obstetric anomalies and pregnancy outcomes. Sociodemographic, medical, and obstetric history was captured.RESULTSThree hundred twenty-six pregnant women were enrolled from Nampula and 940 from Maputo City. Stillbirth prevalence (2·3% vs 1·6%, p = 0·438), low birth weight (8·9% vs 8·2%, p = 0·989), congenital anomalies (1 % vs 0·5%, p = 0·454), neonatal death (2·3% vs 1·6%, p = 0·08), and maternal death (0 % vs 0·2%, p = 0·978) did not differ amongst exposed and non-exposed cohorts. There was an increased rate of pre-term delivery in the exposed cohort (18·4% vs 11·0%, p = 0·011).CONCLUSIONWe did not observe an increased frequency of adverse pregnancy outcomes due to passive nOPV2 exposure. A higher frequency of preterm delivery needs to be further investigated. The data reported herein support the continued use of nOPV2 for poliovirus outbreak response and full licensure of the vaccine.

01 Oct 2023·Medical Decision Making

Health Economic Analysis of Antiviral Drugs in the Global Polio Eradication Endgame

Article

Author: Badizadegan, Kamran ; Kalkowska, Dominika A. ; Thompson, Kimberly M.

Background Polio antiviral drugs (PAVDs) may provide a critical tool in the eradication endgame by stopping poliovirus infections in immunodeficient individuals who may not clear the virus without therapeutic intervention. Although prolonged/chronic poliovirus excreters are rare, they represent a source of poliovirus reintroduction into the general population. Prior studies that assumed the successful cessation of all oral poliovirus vaccine (OPV) use estimated the potential upper bound of the incremental net benefits (INBs) of resource investments in research and development of PAVDs. However, delays in polio eradication, OPV cessation, and the development of PAVDs necessitate an updated economic analysis to reevaluate the costs and benefits of further investments in PAVDs. Methods Using a global integrated model of polio transmission, immunity, vaccine dynamics, risks, and economics, we explore the risks of reintroduction of polio transmission due to immunodeficiency-related vaccine-derived poliovirus (iVDPV) excreters and reevaluate the upper bound of the INBs of PAVDs. Results Under the current conditions, for which the use of OPV will likely continue for the foreseeable future, even with successful eradication of type 1 wild poliovirus by the end of 2023 and continued use of Sabin OPV for outbreak response, we estimate an upper bound INB of 60 million US$2019. With >100 million US$2019 already invested in PAVD development and with the introduction of novel OPVs that are less likely to revert to neurovirulence, our analysis suggests the expected INBs of PAVDs would not offset their costs. Conclusions While PAVDs could play an important role in the polio endgame, their expected economic benefits drop with ongoing OPV use and poliovirus transmissions. However, stakeholders may pursue the development of PAVDs as a desired product regardless of their economic benefits. Highlights While polio antiviral drugs could play an important role in the polio endgame, their expected economic benefits continue to drop with delays in polio eradication and the continued use of oral poliovirus vaccines. The incremental net benefits of investments in polio antiviral drug development and screening for immunodeficiency-related circulating polioviruses are small. Limited global resources are better spent on increasing global population immunity to polioviruses to stop and prevent poliovirus transmission.

01 Sep 2023·The Lancet Infectious Diseases

Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial

Article

Author: Anand, Abhijeet ; An, Qian ; Vertefeuille, John F ; Yunus, Mohammad ; Wilkinson, Amanda L ; Lickness, Jacquelyn S ; Kovacs, Stephanie D ; Abid, Talha ; Zhang, Yiting ; Coffee, Elizabeth ; Wassilak, Steven G F ; Burns, Cara C ; Mainou, Bernardo A ; Oberste, M Steven ; Zaman, Khalequ ; Konopka-Anstadt, Jennifer L ; Estivariz, Concepcion F ; Hoque, Masuma ; Pallansch, Mark A ; Snider, Cynthia J

BACKGROUNDNovel oral poliovirus vaccine type 2 (nOPV2) was developed by modifying the Sabin strain to increase genetic stability and reduce risk of seeding new circulating vaccine-derived poliovirus type 2 outbreaks. Bivalent oral poliovirus vaccine (bOPV; containing Sabin types 1 and 3) is the vaccine of choice for type 1 and type 3 outbreak responses. We aimed to assess immunological interference between nOPV2 and bOPV when administered concomitantly.METHODSWe conducted an open-label, non-inferiority, randomised, controlled trial at two clinical trial sites in Dhaka, Bangladesh. Healthy infants aged 6 weeks were randomly assigned (1:1:1) using block randomisation, stratified by site, to receive nOPV2 only, nOPV2 plus bOPV, or bOPV only, at the ages of 6 weeks, 10 weeks, and 14 weeks. Eligibility criteria included singleton and full term (≥37 weeks' gestation) birth and parents intending to remain in the study area for the duration of study follow-up activities. Poliovirus neutralising antibody titres were measured at the ages of 6 weeks, 10 weeks, 14 weeks, and 18 weeks. The primary outcome was cumulative immune response for all three poliovirus types at the age of 14 weeks (after two doses) and was assessed in the modified intention-to-treat population, which was restricted to participants with adequate blood specimens from all study visits. Safety was assessed in all participants who received at least one dose of study product. A non-inferiority margin of 10% was used to compare single and concomitant administration. This trial is registered with ClinicalTrials.gov, NCT04579510.FINDINGSBetween Feb 8 and Sept 26, 2021, 736 participants (244 in the nOPV2 only group, 246 in the nOPV2 plus bOPV group, and 246 in the bOPV only group) were enrolled and included in the modified intention-to-treat analysis. After two doses, 209 (86%; 95% CI 81-90) participants in the nOPV2 only group and 159 (65%; 58-70) participants in the nOPV2 plus bOPV group had a type 2 poliovirus immune response; 227 (92%; 88-95) participants in the nOPV2 plus bOPV group and 229 (93%; 89-96) participants in the bOPV only group had a type 1 response; and 216 (88%; 83-91) participants in the nOPV2 plus bOPV group and 212 (86%; 81-90) participants in the bOPV only group had a type 3 response. Co-administration was non-inferior to single administration for types 1 and 3, but not for type 2. There were 15 serious adverse events (including three deaths, one in each group, all attributable to sudden infant death syndrome); none were attributed to vaccination.INTERPRETATIONCo-administration of nOPV2 and bOPV interfered with immunogenicity for poliovirus type 2, but not for types 1 and 3. The blunted nOPV2 immunogenicity we observed would be a major drawback of using co-administration as a vaccination strategy.FUNDINGThe US Centers for Disease Control and Prevention.

100 Deals associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Poliomyelitis	-	GSK Plc	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Streptococcal Infections	Phase 1	ML	GSK Plc	18 Jun 2008
Streptococcal Infections	Phase 1	NG	GSK Plc	18 Jun 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	hnbwfxattz(dakrnmpzvl) = akwgsbaqpp yvljofihqh (xvdrrxtsiw, oxrzkpiwpk - nymxoujuap) View more	-	06 Jun 2019
				GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	hnbwfxattz(dakrnmpzvl) = kpovgpazvz yvljofihqh (xvdrrxtsiw, idyoxaiuid - jvzfckjzkn) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(ddqlvzfhel) = edfsmlzfmp pmwubkytxk (nsozimamyp, irvvxxdyle - ipcmapfwww) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(ddqlvzfhel) = edonvdufer pmwubkytxk (nsozimamyp, stbraigndw - pefqunhhuz) View more
NCT00678301 (CTgov)	Phase 3	Streptococcal Infections	365	GSK Biologicals' Synflorix™+GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Synflorix™ + Zilbrix™ Hib + Polio Sabin™)	wifjovauxe(agforgzbxi) = fytmktbedx qysfbxqvow (vejuxzbwtc, jmdllwogal - eyejmeavgq) View more	-	27 Oct 2017
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	wifjovauxe(agforgzbxi) = wlxtmwvqns qysfbxqvow (vejuxzbwtc, matavzfkfu - rdywbhfuvz) View more
NCT01231503 (CTgov)	Phase 2	Malaria	480	Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	ogqerakdhi(zlzhpfirzc) = ohnzfwlans rwxdyzxtdj (bxwgmrhlyi, qvyauqmsog - vbmgzsotaf) View more	-	20 May 2015
				Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	ogqerakdhi(zlzhpfirzc) = vrrrdetdis rwxdyzxtdj (bxwgmrhlyi, qtlvdedqpt - yervjldnva) View more
NCT00263666 (CTgov)	Phase 2	Rotavirus Infections \| HIV Infections	100	Tritanrix-HB+Hib+Rotarix+Polio Sabin (Rotarix Group)	slszqjgwip(vstwvutdce) = tysgrzvolc jdupazbccb (qxdbfczecg, hpiygrsqvx - ebkefvoymt) View more	-	13 Mar 2009
				Placebo+Tritanrix-HB+Hib+Polio Sabin (Placebo Group)	slszqjgwip(vstwvutdce) = kavsbskfiw jdupazbccb (qxdbfczecg, ubdhwzvwnh - lbczlcmnjd) View more