Delving into the Latest Updates on Poliovirus vaccine inactivated(Aj Vaccines A/S) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

IPV-Al, IPV-Al AJV, Inactivated poliovirus vaccine

+ [3]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Poliomyelitis

Inactive Indication-

Originator Organization

Aj Vaccines A/S

Active Organization

Biological E. Ltd.

Inactive Organization

Aj Vaccines A/S

Drug Highest PhaseApproved

First Approval Date

DK (01 Jun 2019),

Poliomyelitis

Regulation-

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The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.

Start Date20 Nov 2020

Sponsor / Collaborator

Aj Vaccines A/S

NCT03671616 / CompletedPhase 3

Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI Given as a Booster Vaccination at the Age of 15-18 Months to Infants Previously Immunised With IPV-Al SSI or IPV SSI

This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

Start Date15 May 2018

Sponsor / Collaborator

Statens Serum Institute

[+4]

NCT03202719 / CompletedPhase 4IIT

Duration of Priming and Antibody Decay With Full-dose Inactivated Poliovirus Vaccine (IPV) Administered With or Without Bivalent Oral Poliovirus Vaccine (bOPV)

This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.

Start Date05 Nov 2017

Sponsor / Collaborator

Centers for Disease Control & Prevention

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100 Clinical Results associated with Poliovirus vaccine inactivated(Aj Vaccines A/S)

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100 Translational Medicine associated with Poliovirus vaccine inactivated(Aj Vaccines A/S)

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100 Patents (Medical) associated with Poliovirus vaccine inactivated(Aj Vaccines A/S)

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619

Literatures (Medical) associated with Poliovirus vaccine inactivated(Aj Vaccines A/S)

02 Oct 2024·Infectious Diseases

The respiratory route of transmission of virulent polioviruses

Review

Author: Hirschhorn, Norbert ; Dharmapalan, Dhanya ; Steinglass, Robert ; John, T. Jacob

AIMSThe route of transmission of wild and circulating vaccine-derived polioviruses remains controversial, between respiratory and faecal-oral, and we aim to identify the most plausible one to settle the controversy.METHODSWe explored available epidemiological clues and evidence in support of either route in order to arrive at an evidence-based conclusion.RESULTSHistorically the original concept was respiratory transmission based on epidemiological features of age distribution, which was later revised to faecal-oral as the rationale for popularising the live attenuated oral polio vaccine in preference to the inactivated poliovirus vaccine. Through epidemiological logic, we find no evidence for the faecal-oral route from available studies and observations, but all available information supports the respiratory route.CONCLUSIONSThe route is respiratory, not faecal-oral. The global polio eradication initiative assumed it was faecal-oral - and its gargantuan efforts based on this assumption have failed in two ways: eradication remains pending and circulating vaccine-derived polioviruses have seeded widely. With clarity on the route of transmission the choice of vaccine is also clear - it can only be the inactivated poliovirus vaccine.

01 Oct 2024·Vaccine

Estimation of the poliovirus type 2 immunity gap in South Africa

Article

Author: Mabhena, Nicoletta ; Molema, Koko ; van Schalkwyk, Cari ; von Gottberg, Anne ; Maseti, Elizabeth ; Brown, Lauren ; Prabdial-Sing, Nishi ; Botha, Sonia ; Sereo, Tumelo ; Bingham, Jeremy ; Mthombothi, Zinhle ; Schönfeldt, Marione ; Kamupira, Mercy ; McCarthy, Kerrigan ; Pulliam, Juliet

In the context of polio eradication efforts, accurate assessment of vaccination programme effectiveness is essential to public health planning and decision making. Such assessments are often based on zero-dose children, estimated using the number of children who did not receive the first dose of the Diphtheria-Tetanus-Pertussis containing vaccine as a proxy. Our study introduces a novel approach to directly estimate the number of children susceptible to poliovirus type 2 (PV2) and uses this approach to provide district-level estimates for South Africa of susceptible children born between 2017 and 2022. We used district-level data on annual doses of inactivated poliovirus vaccine (IPV) administered, live births, and population sizes, from 2017 through 2022. We imputed missing vaccination data, implemented flexible assumptions regarding dose distribution in the eligible population, and used estimated efficacy values for one, two, three, and four doses of IPV, to compute the number of susceptible and immune children by birth year. We validated our approach by comparing an intermediary output with zero-dose children (ZDC) estimated using data reported by WHO/UNICEF Estimates of National Immunization Coverage (WUENIC). Our results indicate high heterogeneity in susceptibility to PV2 across South Africa's 52 districts as of the end of 2022. In children under 5 years, PV2 susceptibility ranged from approximately 30 % in districts including Xhariep (31.9 %), Ekurhuleni (30.1 %), and Central Karoo (29.8 %), to less than 4 % in Sarah Baartman (1.9 %), Buffalo City (2.1 %), and eThekwini (3.2 %). Our susceptibility estimates were consistently higher than ZDC over the timeframe. We estimated that ZDC decreased nationally from 155,168 (152,737-158,523) in 2017 to 108,593 in 2021, and increased to 127,102 in 2022, a trend consistent with ZDC derived from data reported by WUENIC. While our approach provides a more comprehensive profile of PV2 susceptibility, our susceptibility and ZDC estimates generally agree in the ranking of districts according to risk.

01 Sep 2024·Vaccine

Assessing the mucosal intestinal and systemic humoral immunity of sequential schedules of inactivated poliovirus vaccine and bivalent oral poliovirus vaccine for essential immunization in Bangladesh: An open-label, randomized controlled trial

Article

Author: Yunus, Mohammad ; Oberste, M Steven ; Haque, Warda ; Wassilak, Steven G F ; Zaman, Khalequ ; Aziz, Asma Binte ; Anand, Abhijeet ; Pallansch, Mark A ; Weldon, William C ; Hendley, William S ; Snider, Cynthia J ; Estivariz, Concepcion F

In 2012, the Strategic Advisory Group of Experts on Immunization (SAGE) recommended introduction of at least one inactivated poliovirus vaccine (IPV) dose in essential immunization programs. We evaluated systemic humoral and intestinal mucosal immunity of a sequential IPV-bivalent oral poliovirus vaccine (bOPV) schedule compared with a co-administration IPV + bOPV schedule in an open-label, randomized, controlled, non-inferiority, inequality trial in Dhaka, Bangladesh. Healthy infants aged 6 weeks were randomized to either: (A) IPV and bOPV at 6 and bOPV at 10 and 14 weeks (IPV + bOPV-bOPV-bOPV); or (B) IPV at 6 and bOPV at 10 and 14 weeks (IPV-bOPV-bOPV). Of 456 participants enrolled and randomly assigned during May-August 2015, 428 (94%) were included in the modified intention-to-treat analysis (arm A: 211, arm B: 217). Humoral immune responses did not differ at 18 weeks between study arms: type 1 (98% versus 96%; p = 0.42), type 2 (37% versus 39%; p = 0.77), and type 3 (97% versus 93%; p = 0.07). Virus shedding one week after the bOPV challenge dose in arm B was non-inferior to arm A (type 1 difference = -3% [90% confidence interval: -6 - 0.4%]; type 3 difference: -3% [-6 to -0.2%]). Twenty-six adverse events including seven serious adverse events were reported among 25 participants including one death; none were attributed to study vaccines. An IPV-bOPV-bOPV sequential schedule induced comparable systemic humoral immunity to all poliovirus types and types 1 and 3 intestinal mucosal immunity as an IPV + bOPV-bOPV-bOPV co-administration schedule.

100 Deals associated with Poliovirus vaccine inactivated(Aj Vaccines A/S)

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Poliomyelitis	DK	Biological E. Ltd.	01 Jun 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Poliomyelitis	Preclinical	PA	Aj Vaccines A/S	19 Jan 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Lancet Microbe	Not Applicable	-	-	inactivated poliovirus vaccine (Previous IPV group)	xjbnysqnbt(fksswautbl) = umnxcfqoeg hfphgqmcmm (obmoyfpnse )	-	01 Nov 2023
				inactivated poliovirus vaccine (No previous IPV group)	xjbnysqnbt(fksswautbl) = fjeyedovrf hfphgqmcmm (obmoyfpnse )
NCT04448132 (Pubmed) Manual	Phase 4	Poliomyelitis	-	Picovax	(mptlelpbpo) = The vaccine was well tolerated, with only mild and transient AEs reported oqxhpzknlu (uzvcwevnbi ) View more	Positive	22 Sep 2022
NCT03025750 \| NCT03671616 (Pubmed \| Vaccine)	Phase 3	-	-	IPV-Al	(jbcfcavymm) = ootxxavgqy afqyxcctnz (zpaqvxrcmj ) View more	-	06 May 2020
				IPV-Al (Standard IPV)	(jbcfcavymm) = ojiowbgjgm afqyxcctnz (zpaqvxrcmj ) View more
NCT03032419 (Pubmed)	Phase 3	Jaundice, Neonatal	1,002	IPV-Al	(jlwwhjuipa) = wppixwhzqg kyrhnmsqmq (jcjyjstmba )	Positive	16 Jan 2020
				IPV-Al (IPV)	(jlwwhjuipa) = flofbuwxbx kyrhnmsqmq (jcjyjstmba )