Delving into the Latest Updates on Human rotavirus, live attenuated(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms

GSK vaccine 444563, HRV Liquid, HRV Lyophilized

+ [13]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Rotavirus InfectionsViral gastroenteritis due to RotavirusNorovirus Infections

Inactive Indication

FeverHepatitis BMeningitis, Haemophilus+ [2]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Biologicals SA

GSK PlcGlaxoSmithKline LLC

Inactive Organization

GlaxoSmithKline (China) Investment Co., Ltd.

Merck Sharp & Dohme Corp.

Sanofi Pasteur

Drug Highest PhaseApproved

First Approval Date

EU (21 Feb 2006),

Viral gastroenteritis due to Rotavirus

Regulation-

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A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration.

Start Date01 Sep 2023

Sponsor / Collaborator

GSK Plc

NCT05496231 / CompletedPhase 1/2

A Phase 1/2 Randomized, Observer-blinded, Multi-country Study to Evaluate Safety and Immunogenicity of Investigational Adjuvanted Human Papillomavirus Vaccine in Females (16 to 26 Years of Age)

The Main purpose of this study is to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

Start Date22 Aug 2022

Sponsor / Collaborator

GSK Plc

NCT04658914 / Active, not recruitingPhase 2IIT

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world. This study will assess protection against rotavirus infection and investigate immune correlates of protection following vaccination with a novel trivalent VP8 subunit rotavirus vaccine used alone or in combination with oral rotavirus vaccine.

Start Date15 Apr 2021

Sponsor / Collaborator

Centre For Infectious Disease Research

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100 Clinical Results associated with Human rotavirus, live attenuated(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Human rotavirus, live attenuated(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Human rotavirus, live attenuated(GlaxoSmithKline Plc)

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548

Literatures (Medical) associated with Human rotavirus, live attenuated(GlaxoSmithKline Plc)

01 Aug 2024·Virus Research

Circulating rotavirus strains in children with acute gastroenteritis in Iran, 1986 to 2023 and their genetic/antigenic divergence compared to approved vaccines strains (Rotarix, RotaTeq, ROTAVAC, ROTASIIL) before mass vaccination: Clues for vaccination policy makers

Review

Author: Shoja, Zabihollah ; Jalilvand, Somayeh ; Behnezhad, Farzane ; Roohvand, Farzin ; Kachooei, Atefeh ; Mirhoseinian, Mahtab ; Hoseini-Fakhr, Somayeh-Sadat ; Latifi, Tayebeh

In the present study, first, rotaviruses that caused acute gastroenteritis in children under five years of age during the time before the vaccine was introduced in Iran (1986 to 2023) are reviewed. Subsequently, the antigenic epitopes of the VP7 and VP4/VP8 proteins in circulating rotavirus strains in Iran and that of the vaccine strains were compared and their genetic differences in histo-blood group antigens (HBGAs) and the potential impact on rotavirus infection susceptibility and vaccine efficacy were discussed. Overall data indicate that rotavirus was estimated in about 38.1 % of samples tested. The most common genotypes or combinations were G1 and P[8], or G1P[8]. From 2015 to 2023, there was a decline in the prevalence of G1P[8], with intermittent peaks of genotypes G3P[8] and G9P[8]. The analyses suggested that the monovalent Rotarix vaccine or monovalent vaccines containing the G1P[8] component might be proper in areas with a similar rotavirus genotype pattern and genetic background as the Iranian population where the G1P[8] strain is the most predominant and has the ability to bind to HBGA secretors. While the same concept can be applied to RotaTeq and RotasIIL vaccines, their complex vaccine technology, which involves reassortment, makes them less of a priority. The ROTASIIL vaccine, despite not having the VP4 arm (P[5]) as a suitable protection option, has previously shown the ability to neutralize not only G9-lineage I strains but also other G9-lineages at high titers. Thus, vaccination with the ROTASIIL vaccine may be more effective in Iran compared to RotaTeq. However, considering the rotavirus genotypic pattern, ROTAVAC might not be a good choice for Iran. Overall, the findings of this study provide valuable insights into the prevalence of rotavirus strains and the potential effectiveness of different vaccines in the Iranian and similar populations.

25 Jul 2024·The Journal of Infectious Diseases

Differences in Rotavirus Shedding and Duration by Infant Oral Rotavirus Vaccination Status in Dhaka, Bangladesh, 2011–2014

Article

Author: Zaman, K ; Petri, William A ; Colgate, E Ross ; Ciszewski, Jenna ; Platts-Mills, James A ; Kirkpatrick, Beth D ; Haque, Rashidul ; Rogawski McQuade, Elizabeth T ; Lopman, Benjamin ; Lee, Benjamin ; Taniuchi, Mami

AbstractTo evaluate how breakthrough rotavirus disease contributes to transmission, we examined the impact of rotavirus vaccination on fecal shedding and duration of illness. We used multivariable linear regression to analyze rotavirus quantity by RT-qPCR and duration among 184 episodes of rotavirus diarrhea positive by ELISA in the PROVIDE study. Vaccinated children had less fecal viral shedding compared to unvaccinated children (mean difference = −0.59 log copies per gram of stool; 95% confidence interval [CI], −.99 to −.19). Duration of illness was on average 0.47 days (95% CI, −.23 to 1.17 days) shorter among vaccinated children. Rotarix vaccination reduces shedding burden among breakthrough cases of rotavirus gastroenteritis.Clinical Trials Registration . NCT01375647.

01 Jul 2024·Heliyon

Comparative analysis of the RVA VP7 and VP4 antigenic epitopes circulating in Iran and the Rotarix and RotaTeq vaccines

Article

Author: Zahraei, Seyed Mohsen ; Mahmoudi, Sussan ; Fallah, Tina ; Alebouyeh, Masoud ; Karimi, Abdollah ; Mansour Ghanaiee, Roxana

Analyzing the lineages and detecting antigenic variation in immunogenic motifs of Group A Rotavirus (RVA) variants is crucial because it can impact vaccine efficacy. This study investigated the circulating lineages of VP4 and VP7 proteins of human RVA isolates and their phylogeny in ≤24-month-old symptomatic, rotavirus-positive children with transudative diarrhea within 48 h of admission to Mofid Children's Hospital between December 2020 and March 2022 in Tehran, Iran. Antigen detection was performed by ELISA, RNA extraction, and semi-nested multiplex PCR for G/P genotypes, followed by sequencing and bioinformatic analysis using multiple sequence alignments in MEGA and phylogenetic analysis by Geneious Prime. The similarity of VP7 and VP4 amino acids with the RotaTeq and Rotarix vaccine strains for cytotoxic T cell and antigenic epitopes was evaluated using the UCSF Chimera Molecular Modeling System. Overall, 27.3 % of the samples were RVA positive, showing untypeable (2.5 %), single (76.9 %), and mixed (20.5 %) genotypic characteristics. The strains clustered in the G1/II, G2/IV, G3/I, G4/I, G9/III, P (Kachooei et al., 2023) [8]/III, P (Howley et al., 2020) [4]/V, and P (Wahyuni et al., 2021) [6]/I lineages. Comparative analysis of VP7 antigenic epitopes showed that the G1/II strains were completely conserved, while the G2/IV, G3/I, G4/I, G6, G9/III strains contained 2, 3-5, 2, 4 and 9 amino acid substitutions, respectively. The P (Kachooei et al., 2023) [8]/III genotypes differed by 3 amino acids, while the P (Wahyuni et al., 2021) [6]/I genotype had the most substitutions. CTL epitopes were completely conserved in G3/I strains, but other genotypes differed by 1-4 amino acids compared to the vaccine strains. Given the diversity of circulating RVA genotypes and the observed mutations in neutralizing and CTL epitopes, immune escape by some of the strains is likely in Iran. This finding underscores the importance of evaluating the effect of rotavirus vaccines on local genotypes and related lineages before implementing a vaccination program.

100 Deals associated with Human rotavirus, live attenuated(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
Rotavirus Infections	JP	GSK Plc	01 Jul 2011
Viral gastroenteritis due to Rotavirus	LI	GlaxoSmithKline Biologicals SA	21 Feb 2006
Viral gastroenteritis due to Rotavirus	NO	GlaxoSmithKline Biologicals SA	21 Feb 2006
Viral gastroenteritis due to Rotavirus	IS	GlaxoSmithKline Biologicals SA	21 Feb 2006
Viral gastroenteritis due to Rotavirus	EU	GlaxoSmithKline Biologicals SA	21 Feb 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Pneumococcal	Phase 2	MX	GSK Plc	03 Jul 2007
Viral gastroenteritis due to Rotavirus	Phase 2	JP	GSK Plc	19 Jun 2007
Pneumococcal Infections	Discovery	TH	Sanofi Pasteur	28 Jun 2020
Meningitis, Haemophilus	Discovery	KR	GSK Plc	04 Mar 2011
Gastroenteritis	Discovery	CN	GlaxoSmithKline (China) Investment Co., Ltd.	29 Aug 2010
Gastroenteritis	Discovery	CN	GlaxoSmithKline Biologicals SA	29 Aug 2010
Fever	Discovery	CZ	GSK Plc	01 Sep 2006
Rotavirus Infections	Discovery	CO	GSK Plc	01 Aug 2003
Rotavirus Infections	Discovery	MX	GSK Plc	01 Aug 2003
Rotavirus Infections	Discovery	PE	GSK Plc	01 Aug 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03632720 (CTgov)	Phase 3	Meningococcal Infections	788	Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months))	curnkxvxxo(lsaejksbwv) = zuovofoowo udozzzwlzu (deounlasyd, cdnrabiiyl - ykoyfaalkv) View more	-	07 Nov 2023
				Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months))	curnkxvxxo(lsaejksbwv) = dcjfvtipow udozzzwlzu (deounlasyd, blvmsrcyyf - wufmyduikv) View more
NCT04031846 (V114-025 \| PNEU-PED-EU-1, CTgov)	Phase 3	Pneumococcal Infections	1,184	Infanrix™ hexa+Rotarix™+V114 (V114)	szjvlgsxbj(tvohkfmbfo) = laoickqsud lqspsjvgkn (tgqneqhbhg, kvryzspmxm - itwmnqaydb) View more	-	03 May 2023
				Infanrix™ hexa+Rotarix™+Prevenar 13™ (Prevenar 13™)	szjvlgsxbj(tvohkfmbfo) = prwgkxmrmg lqspsjvgkn (tgqneqhbhg, dbknqbjejo - rowrwjfpxb) View more
NCT02847026 (Pubmed) Manual	Phase 4	Rotavirus Infections	1,144	RotaTeq	wcrdymlsvc(xsuwewmhby) = iwrocspfyw yjhlszouyg (unptvypjrb ) View more	Positive	09 Aug 2022
				Rotarix	wcrdymlsvc(xsuwewmhby) = zltvvbugtw yjhlszouyg (unptvypjrb ) View more
NCT02941107 (ORVAC, Pubmed \| Am J Trop Med Hyg)	Phase 4	-	253	Rotarix	(oirobrfkqj) = kwursfvjrt zhwvwfkzzj (wdnnrcghbw )	Positive	04 Feb 2022
				Placebo	(oirobrfkqj) = panflkyuoc zhwvwfkzzj (wdnnrcghbw )
NCT02141204 (CTgov)	Phase 3	Rotavirus Infections	451	HRV Liquid (HRV Liq Group)	mmrqgvunwh(ryzemdmeni) = cseqymeems oerlqxeplt (rzkbejcjhm, rkuhmkstns - ximywzplpf) View more	-	09 Dec 2020
				HRV Lyophilized (HRV Lyo Group)	mmrqgvunwh(ryzemdmeni) = xkjmysrgeq oerlqxeplt (rzkbejcjhm, oyxemibsmb - rcmcoohdaw) View more
NCT02992197 (CTgov)	Phase 4	Rotavirus Infections	220	Placebo (for Rotarix dose 2)+Rotarix, dose 1 (Rotarix, Single Dose)	zhiaoalfbi(mblghieomp) = zpltpikvcc ldkudcyedd (poezhkmjuc, vuaeytbuqu - jrtbkyxegt) View more	-	17 Jul 2020
				Rotarix, dose 2 (Rotarix, Double Dose)	zhiaoalfbi(mblghieomp) = mxxwnsqeov ldkudcyedd (poezhkmjuc, nqtkydrukr - naaeqhqjif) View more
NCT02914184 (CTgov)	Phase 3	Rotavirus Infections \| Viral gastroenteritis due to Rotavirus	1,612	HRV PCV-free liquid vaccine (Liq_A Group)	zwbcsdbysf(bedtxehbtn) = bdzsuiwfts ikpyyxcbiw (wwogjhymke, zljxasfvum - azuvwqowjb) View more	-	14 Oct 2019
				HRV PCV-free liquid vaccine (Liq_B Group)	zwbcsdbysf(bedtxehbtn) = sxzoxwmzlb ikpyyxcbiw (wwogjhymke, tnuahvzewp - nwftbffdwq) View more
NCT01700621 (CTgov)	Phase 4	Rotavirus Infections \| Rubella \| Measles	482	Rotarix vaccine+measles-rubella vaccine (Measles-rubella and Rotavirus Vaccines)	txufnhjgbf(ujybdxhzfl): Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)	-	18 Feb 2019
				measles-rubella vaccine (Measles-rubella Vaccine)
NCT02907216 (CTgov)	Phase 4	Diphtheria \| Rotavirus Infections \| Whooping Cough \| Tetanus	292	Squarekids+Rotarix (Co-administration Group)	mcfpsvrppt(qnhqlmrrbp) = bepdzubgkw ottgadfhmn (alydclnzzn, awousqdcke - dticeeejrp) View more	-	23 Jan 2019
				Squarekids+Rotarix (Staggered Group)	mcfpsvrppt(qnhqlmrrbp) = nmruiglxtu ottgadfhmn (alydclnzzn, yholvybade - sadxmrlqbc) View more
NCT02096263 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	585	Hiberix+Infanrix+Infanrix hexa+Rotarix+Prevnar13 (Infanrix Hexa Group)	cogbebibsd(ogtfrzbwoj) = tidhvizswo bcaiwkdoej (uxmapexqzi, bnqcqskxks - nzjfrvjvre) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	cogbebibsd(ogtfrzbwoj) = xbwinejahb bcaiwkdoej (uxmapexqzi, kzkhymolie - ltfxoioill) View more