Delving into the Latest Updates on Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Pneumococcal vaccine recombinant, S. pneumoniae adult vaccine

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesOtorhinolaryngologic Diseases

Active Indication-

Inactive Indication

Infection of earOtitis MediaStreptococcal Infections

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Start Date21 May 2012

Sponsor / Collaborator

GSK Plc

NCT01262872 / CompletedPhase 2

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Start Date09 Feb 2011

Sponsor / Collaborator

GSK Plc

[+3]

NCT01204658 / CompletedPhase 2

Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Start Date27 Sep 2010

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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97

Literatures (Medical) associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

01 Dec 2024·The Lancet Regional Health - Southeast Asia

Routine immunization against Streptococcus pneumoniae and Haemophilus influenzae type B and antibiotic consumption in India: a dynamic modeling analysis

Article

Author: Kumar, Chirag K ; Nandi, Arindam ; Laxminarayan, Ramanan ; Gleason, Alec C. ; Parameswaran, Giridara Gopal ; Kumar, Chirag K. ; Summan, Amit ; Klein, Eili ; Gleason, Alec C

BackgroundChildhood vaccinations can reduce disease burden and associated antibiotic use, in turn reducing the risk of antimicrobial resistance (AMR). We retrospectively estimated the population-level reductions in antibiotic use in India following the introduction of vaccines against Streptococcus pneumoniae and Haemophilius influenzae type B in the national immunization program for children in the mid-2010s and projected future gains to 2028 if vaccination coverage were to be increased.MethodsUsing IndiaSim, a dynamic agent-based microsimulation model (ABM) for India, we simulated the spread of Streptococcus pneumoniae and Haemophilius influenzae type B (Hib) among children to estimate reductions in antibiotic use under the scenarios of: (i) pneumococcal and Hib vaccine coverage levels equivalent to the national coverage of pentavalent diphtheria-pertussis-tetanus third dose (DPT3) compared to a baseline of no vaccination, and (ii) near-universal (90%) coverage of the vaccines compared to pre-COVID national DPT3-level coverage. Model parameters, including national DPT3 coverage rates, were based on data from the National Family Household Survey 2015-2016 and other published sources. We quantified reductions in antibiotic consumption nationally and by state and wealth quintiles.FindingsWe estimate that coverage of S. pneumoniae and Hib vaccines at the same level as DPT3 in India would translate to a 61.4% [95% UI: 43.8-69.5] reduction in attributable antibiotic use compared to a baseline of zero vaccination coverage. Increases in childhood vaccination coverage between 2004 and 2016 have likely reduced attributable antibiotic demand by as much as 93.4% among the poorest quintile. Increasing vaccination coverage by an additional 11 percentage points from 2016 levels results in mortality and antibiotic use across wealth quintiles becoming increasingly similar (p < 0.05), reducing in health inquities. We project that near-universal vaccine coverage would further reduce inequities in antibiotic demand and may eliminate of outbreak-associated antibiotic use from S. pneumoniae and Hib.InterpretationThough vaccination has a complex relationship with antibiotic use because both are modulated by socioeconomic factors, increasing vaccinations for S. pneumoniae and Hib may have a significant impact on reducing antibiotic use and improving health outcomes among the poorest individuals.FundingThe Bill & Melinda Gates Foundation (grant numbers OPP1158136 and OPP1190803).

18 Sep 2023·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.

Article

Author: Long, Raj ; Dale, James B ; Kim, Jerome H ; Excler, Jean-Louis ; Fulurija, Alma ; Cavaleri, Marco ; McCulloch, Mignon ; Asturias, Edwin J ; Zühlke, Liesl ; Ackland, James ; Steer, Andrew C ; Sun, Wellington ; Sriskandan, Shiranee

Streptococcus pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium's (SAVAC's) mission is to accelerate the development of safe, effective, and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early-phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early-phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

01 Sep 2023·Molecular Immunology

ΔA146Ply-HA stem protein immunization protects mice against influenza A virus infection and co-infection with Streptococcus pneumoniae

Article

Author: Wang, Hanyi ; Li, Lian ; Xu, Wenlong ; Yang, Rui ; Zhang, Xuemei ; Yuan, Yuan ; Yin, Yibing ; Xiao, Jiangming ; Guo, Ting

Influenza virus (IV) is a common pathogen affecting the upper respiratory tract, that causes various diseases. Secondary bacterial pneumonia is a common complication and a major cause of death in influenza patients. Streptococcus pneumoniae (S. pneumoniae) is the predominant co-infected bacteria in the pandemic, which colonizes healthy people but can cause diseases in immunocompromised individuals. Vaccination is a crucial strategy for avoiding infection, however, no universal influenza vaccine (UIV) that is resistant to multiple influenza viruses is available. Despite its limited immunogenicity, the hemagglutinin (HA) stem is a candidate peptide for UIV. ΔA146Ply (pneumolysin with a single deletion of A146) not only retains the Toll-like receptor 4 agonist effect but also is a potential vaccine adjuvant and a candidate protein for the S. pneumoniae vaccine. We constructed the fusion protein ΔA146Ply-HA stem and studied its immunoprotective effect in mice infection models. The results showed that intramuscular immunization of ΔA146Ply-HA stem without adjuvant could induce specific antibodies against HA stem and specific CD4⁺ T and CD8⁺ T cellular immunity in BALB/c and C57BL/6 mice, which could improve the survival rate of mice infected with IAV and co-infected with S. pneumoniae, but the protective effect on BALB/c mice was better than that on C57BL/6 mice. ΔA146Ply-HA stem serum antibody could protect BALB/c and C57BL/6 mice from IAV, and recognized HA polypeptides of H3N2, H5N1, H7N9, and H9N2 viruses. Moreover, ΔA146Ply-HA stem intramuscular immunization had a high safety profile with no obvious toxic side effects. The results indicated that coupling ΔA146Ply with influenza protein as a vaccine was a safe and effective strategy against the IV and secondary S. pneumoniae infection.

100 Deals associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infection of ear	Phase 2	US	GSK Plc	21 May 2012
Otitis Media	Phase 2	US	GSK Plc	21 May 2012
Streptococcal Infections	Phase 2	CZ	GSK Plc	24 Nov 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00985751 (CTgov)	Phase 2	Streptococcal Infections	257	Synflorix (Synflorix Group)	ulsidwvifc(vltidxugfy) = aylxvtyhcx sgxjcrpqew (qsqtvqwowt, vovhacttef - xmhhirqhcd) View more	-	06 Oct 2017
				Synflorix+GSK 2189242A (Synflorix/GSK 2189242A Group)	ulsidwvifc(vltidxugfy) = mwgedaeqqf sgxjcrpqew (qsqtvqwowt, winliywwlm - kqzpufsass)
NCT01545375 (CTgov)	Phase 2	Streptococcal Infections \| Infection of ear \| Otitis Media	1,806	Pneumococcal vaccine GSK2189242A+PedvaxHIB®+Prevnar 13® (dPly-PhtD Group)	hfzbthshru(dnupjosohj) = enubbkvxwx liuwawwtpl (ztcezekkno, cjuzatzhwh - cnzoaprnww) View more	-	12 Sep 2017
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	hfzbthshru(dnupjosohj) = lohecpbkyb liuwawwtpl (ztcezekkno, goqtfnrqfn - ymlylliqse) View more
NCT00896064 (CTgov)	Phase 2	Streptococcal Infections	43	GSK2189242A (GSK2189242A Formulation 1 Group)	(xlsmnnksxn) = gxjpaanuxs orphhkiewz (xcbygyygfq, qkpeantvkf - egusfnpyzv) View more	-	19 Jul 2017
				GSK2189242A (GSK2189242A Formulation 2 Group)	(xlsmnnksxn) = vpvfrgniwv orphhkiewz (xcbygyygfq, bsevkjjffe - tlssnkurka) View more
NCT01204658 (CTgov)	Phase 2	Streptococcal Infections	576	Pneumococcal vaccine GSK 2189242A (LD formulation 1)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-LD/Infanrix Hexa Group)	rdqnwphbnd(olvuprajmp) = tbdgdnudhs ouhacyfywg (nlcahkedwl, dlfwrivqip - hatfwflcvz) View more	-	28 Sep 2016
				Pneumococcal vaccine GSK 2189242A (HD formulation 2)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-HD/Infanrix Hexa Group)	rdqnwphbnd(olvuprajmp) = bkgxuaiczm ouhacyfywg (nlcahkedwl, jyksjuoobq - xrkrxcgjob) View more