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

+ [3]

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-

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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96

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

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: Xu, Wenlong ; Li, Lian ; Wang, Hanyi ; 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.

31 May 2023·Veterinary sciences

Development of a Universal Multi-Epitope Vaccine Candidate against Streptococcus suis Infections Using Immunoinformatics Approaches.

Article

Author: Xiong, Yangjing ; Wang, Zhaofei ; Sun, Jianhe ; Cheng, Yuqiang ; Ma, Jingjiao ; Zhang, Yumin ; Wang, Henan ; Chen, Yifan ; Zhao, Guoqing ; Yan, Yaxian ; Li, Feiyu

Streptococcus suis is a significant zoonotic pathogen that is a great threat not only to the swine industry but also to human health, causing arthritis, meningitis, and even streptococcal toxic shock-like syndrome. Owing to its many serotypes and high geographic variability, an efficacious cross-protective S. suis vaccine is not readily available. Therefore, this study aimed to design a universal multi-epitope vaccine (MVHP6) that involved three highly immunogenic proteins of S. suis, namely, the surface antigen containing a glycosaminoglycan binding domain (HP0197), endopeptidase (PepO), and 6-phosphogluconate dehydrogenase (6PGD). Forecasted T-cell and B-cell epitopes with high antigenic properties and a suitable adjuvant were linked to construct a multi-epitope vaccine. In silico analysis showed that the selected epitopes were conserved in highly susceptible serotypes for humans. Thereafter, we evaluated the different parameters of MVHP6 and showed that MVHP6 was highly antigenic, non-toxic, and non-allergenic. To verify whether the vaccine could display appropriate epitopes and maintain high stability, the MVHP6 tertiary structure was modeled, refined, and validated. Molecular docking studies revealed a strong binding interaction between the vaccine and the toll-like receptor (TLR4), whereas molecular dynamics simulations demonstrated the vaccine's compatibility, binding stability, and structural compactness. Moreover, the in silico analysis showed that MVHP6 could evoke strong immune responses and enable worldwide population coverage. Moreover, MVHP6 was cloned into the pET28a (+) vector in silico to ensure the credibility, validation, and proper expression of the vaccine construct. The findings suggested that the proposed multi-epitope vaccine can provide cross-protection against S. suis infections.

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)	bmkjgcylzw(rcuglrulpn) = ouxurdytmz tdmjwikepm (heybhelmod, ueylsuzljz - aqfegpwxcs) View more	-	06 Oct 2017
				Synflorix+GSK 2189242A (Synflorix/GSK 2189242A Group)	bmkjgcylzw(rcuglrulpn) = tjurxzbkfm tdmjwikepm (heybhelmod, kxgvvwbphu - rualuoivxe)
NCT01545375 (CTgov)	Phase 2	Streptococcal Infections \| Infection of ear \| Otitis Media	1,806	Pneumococcal vaccine GSK2189242A+PedvaxHIB®+Prevnar 13® (dPly-PhtD Group)	kuqrpbjjmb(wfimuukkxj) = ekysorzcbd kyonkxozut (qyjxcfbpju, zjtavyrvsl - xzaagsjgex) View more	-	12 Sep 2017
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	kuqrpbjjmb(wfimuukkxj) = tlnygyamkk kyonkxozut (qyjxcfbpju, ahuymhvexf - kvywoluucq) View more
NCT00896064 (CTgov)	Phase 2	Streptococcal Infections	43	GSK2189242A (GSK2189242A Formulation 1 Group)	(tvbhuqwucq) = pktrrlnacf qifgiaghxn (yobfubfeds, undglfyzlf - kcsewasxtc) View more	-	19 Jul 2017
				GSK2189242A (GSK2189242A Formulation 2 Group)	(tvbhuqwucq) = nbqajibhrl qifgiaghxn (yobfubfeds, nxbgxnznhg - gimnzcqfeg) 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)	yujqznritz(aqekpmhbpm) = gnfbaxpnrl lzehdfgpzg (xcbliucsoz, qsvnpsihog - jwghlkeovg) View more	-	28 Sep 2016
				Pneumococcal vaccine GSK 2189242A (HD formulation 2)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-HD/Infanrix Hexa Group)	yujqznritz(aqekpmhbpm) = denzqugjvy lzehdfgpzg (xcbliucsoz, rotuqhbuny - wkavafphgu) View more