Delving into the Latest Updates on ChAd155 RSV with Synapse

Overview

Basic Info

Drug Type

Recombinant vector vaccine, Prophylactic vaccine

Synonyms

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Respiratory Syncytial Virus InfectionsViral respiratory infection

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.

Start Date08 Apr 2019

Sponsor / Collaborator

GSK Plc

NCT02927873

/ CompletedPhase 1/2

A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Start Date11 Jan 2017

Sponsor / Collaborator

GSK Plc

NCT02491463

/ CompletedPhase 1

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults

The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Start Date23 Jul 2015

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with ChAd155 RSV

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100 Translational Medicine associated with ChAd155 RSV

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100 Patents (Medical) associated with ChAd155 RSV

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6

Literatures (Medical) associated with ChAd155 RSV

12 Jan 2024·The Journal of Infectious Diseases

Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6–7 Months of age: A Phase 1/2 Randomized Trial

Article

Author: Szymański, Henryk ; Macias-Parra, Mercedes ; Lopez-Medina, Eduardo ; Martinón-Torres, Federico ; Lopez, Antonio Gonzalez ; Vanhoutte, Nicolas ; Pinto, Jorge ; Arribas, Jose Manuel Merino ; Kuchar, Ernest ; Pu, Wenji ; Ince, Tolga ; Boucher, François D ; McPhee, Roderick ; Díez-Domingo, Javier ; Norero, Ximena ; Epalza, Cristina ; Dinleyici, Ener Cagri ; Gattinara, Guido Castelli ; De Leon, Tirza ; Dieussaert, Ilse ; Campbell, James D ; Mussi-Pinhata, Marisa Márcia ; Gabriel, Miguel Ángel Marín ; Sáez-Llorens, Xavier ; Faust, Saul N ; de la Cueva, Ignacio Salamanca ; Baquero-Artigao, Fernando ; Ramos Amador, Jose Tomas ; Tapiero, Bruce ; Luciani, Kathia ; Brzostek, Jerzy ; Rämet, Mika ; Langley, Joanne M ; Cetin, Benhur S ; Anderson, Evan J ; Stoszek, Sonia K ; Szenborn, Leszek ; Puthanakit, Thanyawee ; Nikic, Vanja ; Zhou, Yingjun ; Friel, Damien

AbstractBackgroundRespiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants.MethodsHealthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years.ResultsTwo hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post–ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post–dose 2.ConclusionsChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response.Clinical Trials Registration. NCT03636906.

29 May 2023·The Journal of Infectious Diseases

Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12–23 Months of Age

Article

Author: Domachowske, Joseph B ; Rodriguez-Weber, Miguel A ; Nikic, Vanja ; Martinón-Torres, Federico ; Chiu, Cheng-Hsun ; Huang, Li-Min ; Epalza, Cristina ; Dieussaert, Ilse ; Gonzalez Lopez, Antonio ; Sáez-Llorens, Xavier ; Baquero-Artigao, Fernando ; Lin, Chien-Yu ; Díez-Domingo, Javier ; Woo, Wayne ; Leach, Amanda ; Moris, Philippe ; Vanhoutte, Nicolas ; Ramos Amador, José T ; Chiu, Nan-Chang ; Zhou, Yingjun ; Chatterjee, Archana ; Lien-Anh Nguyen, Thi ; Esposito, Susanna ; Berry, Andrea A ; Langley, Joanne M

AbstractBackgroundSafe and effective respiratory syncytial virus (RSV) vaccines remain elusive. This was a phase I/II trial (NCT02927873) of ChAd155-RSV, an investigational chimpanzee adenovirus-RSV vaccine expressing 3 proteins (fusion, nucleoprotein, and M2-1), administered to 12–23-month-old RSV-seropositive children followed up for 2 years after vaccination.MethodsChildren were randomized to receive 2 doses of ChAd155-RSV or placebo (at a 1:1 ratio) (days 1 and 31). Doses escalated from 0.5 × 1010 (low dose [LD]) to 1.5 × 1010 (medium dose [MD]) to 5 × 1010 (high dose [HD]) viral particles after safety assessment. Study end points included anti–RSV-A neutralizing antibody (Nab) titers through year 1 and safety through year 2.ResultsEighty-two participants were vaccinated, including 11, 14, and 18 in the RSV-LD, RSV-MD, and RSV-HD groups, respectively, and 39 in the placebo groups. Solicited adverse events were similar across groups, except for fever (more frequent with RSV-HD). Most fevers were mild (≤38.5°C). No vaccine-related serious adverse events or RSV-related hospitalizations were reported. There was a dose-dependent increase in RSV-A Nab titers in all groups after dose 1, without further increase after dose 2. RSV-A Nab titers remained higher than prevaccination levels at year 1.ConclusionsThree ChAd155-RSV dosages were found to be well tolerated. A dose-dependent immune response was observed after dose 1, with no observed booster effect after dose 2. Further investigation of ChAd155-RSV in RSV-seronegative children is warranted.Clinical Trials RegistrationNCT02927873.

01 Aug 2022·International Journal of Toxicology

Repeated-Dose Toxicity, Biodistribution, and Shedding Assessments With a ChAd155 Respiratory Syncytial Virus Vaccine Candidate Evaluated in Rabbits and Rats

Article

Author: Steff, Ann-Muriel ; Planty, Camille ; Bansard, Carine ; Papineau, Dominique ; Song, Haifeng ; Destexhe, Eric ; Spickler, Catherine ; Ben Abdeljelil, Nawel ; Pion, Johanne ; Blouin, Karine ; Baumeister, Judith ; Maruggi, Giulietta ; Stokes, Alan H. ; Silvano, Jérémy ; Rogue, Alexandra ; Dubois, Guillaume ; Ancian, Philippe ; Rodriguez, Luis-Alexander

Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections (LRTI) in infants, and toddlers and vaccines are not yet available. A pediatric RSV vaccine (ChAd155-RSV) is being developed to protect infants against RSV disease. The ChAd155-RSV vaccine consists of a recombinant replication-deficient chimpanzee-derived adenovirus (ChAd) group C vector engineered to express the RSV antigens F, N, and M2-1. The local and systemic effects of three bi-weekly intramuscular injections of the ChAd155-RSV vaccine was tested in a repeated-dose toxicity study in rabbits. After three intramuscular doses, the ChAd155-RSV vaccine was considered well-tolerated. Changes due to the vaccine-elicited inflammatory reaction/immune response were observed along with transient decreases in platelet count without physiological consequences, already reported for other adenovirus-based vaccines. In addition, the biodistribution and shedding of ChAd155-RSV were also characterized in two studies in rats. The distribution and persistence of the ChAd155-RSV vaccine candidate was consistent with other similar adenovector-based vaccines, with quantifiable levels of ChAd155-RSV observed at the injection site (muscle) and the draining lymph nodes up to 69 days post administration. The shedding results demonstrated that ChAd155-RSV was generally not detectable in any secretions or excreta samples. In conclusion, the ChAd155-RSV vaccine was well-tolerated locally and systemically.

100 Deals associated with ChAd155 RSV

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Phase 2	Panama	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Poland	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Mexico	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Panama	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Poland	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Spain	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Taiwan Province	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Mexico	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Spain	GSK Plc	-
Respiratory Syncytial Virus Infections	Phase 2	Taiwan Province	GSK Plc	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03636906 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	201	GSK's pneumococcal polysaccharide conjugate vaccine+GSK's multicomponent meningococcal B vaccine+Y conjugate vaccine+Pfizer's meningococcal group A, C, W-135+RSV (GSK3389245A) lower dose formulation vaccine (RSV1D Pooled Group)	flwuxuspne(lijczzbebr) = aymddrxgsh oitupviydw (rhvpduypzr, jewyawjfgm - uzdvlisaxv) View more	-	27 Jul 2022
				GSK's pneumococcal polysaccharide conjugate vaccine+GSK's multicomponent meningococcal B vaccine+Y conjugate vaccine+Pfizer's meningococcal group A, C, W-135+RSV (GSK3389245A) higher dose formulation vaccine (RSV2D Pooled Group)	flwuxuspne(lijczzbebr) = vrauwmnney oitupviydw (rhvpduypzr, mvovopiegn - tprnuqrgkz) View more
NCT02927873 (CTgov)	Phase 1/2	Respiratory Syncytial Virus Infections	107	RSV (GSK3389245A) low dose formulation vaccine (RSV LD Group)	ahyhwybyqb(bbsvoxnlfo) = qzxftivktd ynfsxkwddg (gthtpdniyo, xbynvpnlmn - oxfgcptcqg) View more	-	28 Oct 2021
				RSV (GSK3389245A) middle dose formulation vaccine (RSV MD Group)	ahyhwybyqb(bbsvoxnlfo) = hztyfotezm ynfsxkwddg (gthtpdniyo, blycghaxwk - wcsyaaicon) View more
NCT02491463 (CTgov)	Phase 1	Viral respiratory infection	73	GSK3389245A_LD GROUP (GSK3389245A_LD Group)	jylkstyghm(kmzdenwmfr) = eekwcmxqmt rzbaetvvzk (usjrtpnykx, llxornoadn - kpszmlgxny) View more	-	20 Aug 2018
				GSK3389245A_HD GROUP (GSK3389245A_HD Group)	jylkstyghm(kmzdenwmfr) = mzzhzdyeoe rzbaetvvzk (usjrtpnykx, hzvzwqmwxd - kurmhwaplb) View more