Delving into the Latest Updates on Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Arepanrix H1N1, H1N1 pandemic influenza virus vaccine (GSK), Influenza A H1N1 split virion vaccine (GSK)

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

GlaxoSmithKline Biologicals SA

Active Organization-

Inactive Organization

GlaxoSmithKline Biologicals SA

GSK Plc

Drug Highest PhaseWithdrawn

First Approval Date

EU (23 Mar 2010),

Influenza, Human

Regulation-

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The goal of the study is to assess the risk of occurrence of narcolepsy following the administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the province of Quebec, Canada, using different case definitions and time intervals to disease onset, while controlling for potential confounding variables such as age, gender, season and, when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the epidemiology and clinical features of narcolepsy cases with onset during the period January 1st, 2009 to December 31, 2010 in the population of Quebec.

Start Date01 Jun 2011

Sponsor / Collaborator

Hopital du Sacré-Coeur de Montréal

[+1]

NCT01161160

/ CompletedPhase 2

An Observer-blind Safety and Immunogenicity Study of GSK Biologicals' A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340272A in Children 3 to Less Than 10 Years Old

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

Start Date01 Jul 2010

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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100 Translational Medicine associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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100 Patents (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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112

Literatures (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

01 Jan 2025·Veterinary Microbiology

Lovastatin enhances humoral and cellular immune responses to H1N1 influenza vaccine

Article

Author: Sun, Haifeng ; Zhang, Shun ; Wang, Deyun ; Cai, Ting ; Yu, Ruihong ; Wang, Zheng ; Jiao, Lina ; Song, Zuchen ; Sun, Yuechao ; Zhou, Yantong ; Miao, Jinfeng ; Zhu, Tianyu ; Liu, Huina ; Liu, Zhenguang ; Qiu, Yawei

The Swine Influenza Virus (SIV) is a major respiratory pathogen in swine, causing acute, febrile, and highly transmissible infections. This virus is widespread globally and poses significant risks to human health and social development. Traditional prevention strategies for SIV rely on the use of inactivated vaccines combined with Alum adjuvants. However, this method is limited by insufficient protection due to the lack of cellular immunity provided by Alum adjuvants. In this study, we investigated the effect of lovastatin, a specific inhibitor of the mevalonate pathway, on the immune response in mice vaccinated with the H1N1 vaccine. We focused on its impact on antibody production, as well as T-cell and B-cell development. Our findings reveal that the combination of lovastatin and H1N1 vaccine (Lov/H1N1) significantly enhances the production of H1N1-specific serum IgG and hemagglutination inhibition (HI) antibodies. Additionally, it promotes T-cell activation in both draining lymph nodes (dLNs) and the spleen. Analysis of cytokines produced after antigenic restimulation of splenic lymphocytes from immunized mice showed that the Lov/H1N1 combination induces both Th1-type (IFNγ, TNFα) and Th2-type (IL4, IL6) responses. Moreover, Lov/H1N1 facilitates the formation of germinal centers (GCs), which are crucial for the generation of memory B cells and long-lived plasma cells. These results indicate that lovastatin is a promising adjuvant candidate, capable of inducing robust cellular and humoral immune responses, thereby overcoming the limitations of Alum adjuvants. Our study provides a foundation for future research on combined vaccine strategies, highlighting Lovastatin's potential to enhance vaccine efficacy through improved immune responses.

01 Dec 2022·Immunity & Ageing

Poly-γ-glutamic acid/Alum adjuvanted pH1N1 vaccine-immunized aged mice exhibit a significant increase in vaccine efficacy with a decrease in age-associated CD8+ T cell proportion in splenocytes

Article

Author: Poo, Haryoung ; Kim, Jaemoo ; Kwak, Chaewon ; Yang, Jihyun

AbstractBackgroundHighly contagious respiratory diseases caused by viral infections are a constantly emerging threat, particularly the elderly with the higher risk of developing serious complications. Vaccines are the best strategy for protection against influenza-related diseases. However, the elderly has lower vaccine efficacy than young population and the age-driven decline of the influenza vaccine efficacy remains unresolved.ObjectivesThis study investigates the effect of an adjuvant, poly-γ-glutamic acid and alum (PGA/Alum) on vaccine efficacy in aged mice (18-months) and its mechanism is investigated using ovalbumin as a model antigen and a commercial pandemic H1N1 (pH1N1) flu vaccine. Antigen trafficking, dendritic cell (DC) activation, and the DC-mediated T cell activation were analyzed via in vivo imaging and flow cytometry. Antigen-specific humoral and cellular immune responses were evaluated in sera and splenocytes from the vaccinated mice. Also, we analyzed gene expression profiles of splenocytes from the vaccinated mice via single-cell transcriptome sequencing and evaluated the protective efficacy against pH1N1 virus challenge.ResultsAged mice had lower antigen trafficking and DC activation than younger mice (6-weeks), which was ameliorated by PGA/Alum with increased antigen uptake and DC activation leading to improved antigen-specific IFN-γ+CD8+ T lymphocyte frequencies higher in the vaccinated aged mice, to a similar extent as PGA/Alum adjuvanted vaccine-immunized young mice. The results of single-cell transcriptome sequencing display that PGA/Alum also reduced the proportion of age-associated CD8+ T cell subsets and gene levels of inhibitory regulators in CD8+ T cells, which may play a role in the recovery of CD8+ T cell activation. Finally, PGA/Alum adjuvanted pH1N1 vaccine-immunized aged mice were completely protected (100% survival) compared to aged mice immunized with vaccine only (0% survival) after pH1N1 virus challenge, akin to the efficacy of the vaccinated young mice (100% survival).ConclusionsPGA/Alum adjuvanted pH1N1 vaccine-immunized aged mice showed a significant increase in vaccine efficacy compared to aged mice administered with vaccine only. The enhanced vaccine efficacy by PGA/Alum is associated with significant increases of activation of DCs and effector CD8+ T cells and a decrease in age-associated CD8+ T cell proportion of splenocytes. Collectively, PGA/Alum adjuvanted flu vaccine may be a promising vaccine candidate for the elderly.

01 Feb 2020·VaccineQ3 · MEDICINE

Pandemic influenza A(H1N1pdm09) vaccine induced high levels of influenza-specific IgG and IgM antibodies as analyzed by enzyme immunoassay and dual-mode multiplex microarray immunoassay methods

Q3 · MEDICINE

Article

Author: Thedi Ziegler ; Henna Päkkilä ; Ritva Syrjänen ; Matti Waris ; Laura Kakkola ; Ilkka Julkunen ; Tero Soukka ; Anna Kazakova

Influenza A viruses continue to circulate throughout the world as yearly epidemics or occasional pandemics. Influenza infections can be prevented by seasonal multivalent or monovalent pandemic vaccines. In the present study, we describe a novel multiplex microarray immunoassay (MAIA) for simultaneous measurement of virus-specific IgG and IgM antibodies using Pandemrix-vaccinated adult sera collected at day 0 and 28 and 180 days after vaccination as the study material. MAIA showed excellent correlation with a conventional enzyme immunoassay (EIA) in both IgG and IgM anti-influenza A antibodies and good correlation with hemagglutination inhibition (HI) test. Pandemrix vaccine induced 5-30 fold increases in anti-H1N1pdm09 influenza antibodies as measured by HI, EIA or MAIA. A clear increase in virus-specific IgG antibodies was found in 93-97% of vaccinees by MAIA and EIA. Virus-specific IgM antibodies were found in 90-92% of vaccinees by MAIA and EIA, respectively and IgM antibodies persisted for up to 6 months after vaccination in 55-62% of the vaccinees. Pandemic influenza vaccine induced strong anti-influenza A IgG and IgM responses that persisted several months after vaccination. MAIA was demonstrated to be an excellent method for simultaneous measurement of antiviral IgG and IgM antibodies against multiple virus antigens. Thus the method is well suitable for large scale epidemiological and vaccine immunity studies.

1

News (Medical) associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

18 Jul 2022

·endpts.com

GSK nets a deal with Canadian government for flu vaccine manufacturing

While Covid-19 and monkeypox manufacturers are getting more ontracts, the Canadian government is still concerned with the flu, especially as its season will soon be upon North America in a few months. Last Friday, GSK announced an agreement with the Canadian government to manufacture pandemic and seasonal influenza vaccines. The four-year agreement, which extends through March 2026, includes GSK supplying as many as 80 million doses of Arepanrix, an adjuvanted pandemic flu vaccine, in case there is an influenza pandemic. The deal will also have GSK produce a minimum of 4 million doses per year of the seasonal flu vaccine Flulaval Tetra. Both vaccines will be manufactured at its 230,000-square-foot facility in Sainte-Foy, Quebec.

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100 Deals associated with Pandemic influenza vaccine (H1N1)(GlaxoSmithKline Biologicals SA)

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	IS	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Phase 2	EU	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Phase 2	LI	GlaxoSmithKline Biologicals SA	23 Mar 2010
Influenza, Human	Phase 2	NO	GlaxoSmithKline Biologicals SA	23 Mar 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01003418 (CTgov)	Phase 2	Influenza, Human	8	GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine+Prevenar+Infanrix™-IPV/Hib (GSK2340272A Group 1)	(nnyqcmzlhh) = wwgwccsnld zovyikvnay (gnhwksbcoa, medeyujhcw - ztpzhnothj) View more	-	15 Feb 2019
				GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine+Prevenar+Infanrix™-IPV/Hib (GSK2340272A Group 2)	(nnyqcmzlhh) = hgfzindfdf zovyikvnay (gnhwksbcoa, koaagywemc - bgsestzsgn) View more
NCT00992511 (CTgov)	Phase 3	Influenza, Human	300	GSK investigational vaccine GSK2340272A (GSK2340272A New 1D Group)	mfoccxzjrp(ecmiaaahhq) = ealyfbebwg thfubqqfgz (krdrrioeqp, ukpkolifip - jqxsbrvnzt) View more	-	31 Jan 2019
				GSK investigational vaccine GSK2340272A (GSK2340272A New 2D Group)	mfoccxzjrp(ecmiaaahhq) = vfsrgbckgu thfubqqfgz (krdrrioeqp, fdyabfzped - oycgwwsxdr) View more
NCT00975884 (CTgov)	Phase 3	Influenza, Human	312	GSK investigational vaccine GSK2340272A (GSK2340272A (D21) GROUP)	gwjnezfgyb(fnomyeizvf) = qbqitwumpg twjojlclxd (fgqgeayxlo, voycqongbu - ymkqagdznc) View more	-	28 Jan 2019
				GSK investigational vaccine GSK2340272A (GSK2340272A (M6) GROUP)	gwjnezfgyb(fnomyeizvf) = wfybbenbrd twjojlclxd (fgqgeayxlo, dnwskrdgde - wzjcnknbvt) View more
NCT00989612 (CTgov)	Phase 2	Influenza, Human	100	Influenza investigational vaccine GSK2340274A	dlfsxrhmof(gqfamrelwd) = edfxknxihf xlhtkenbnm (iqddfoouib, iqdjivafna - ddcbatbvhc) View more	-	16 Jan 2019
NCT00951041 (CTgov)	Phase 2	Influenza, Human	130	GSK investigational vaccine GSK2340272A (GSK2340272A Group)	nakjtyeijw(qbursfclsf) = zigwqfvtuy dxoyupxuhy (btslkqyapk, ckewjnxlma - zfzexxwyml) View more	-	26 Nov 2018
				GSK investigational vaccine GSK2340269A (GSK2340269A Group)	nakjtyeijw(qbursfclsf) = jpdntmswbx dxoyupxuhy (btslkqyapk, alfedunnch - nwavakxsgd) View more
NCT00968526 (CTgov)	Phase 3	Influenza, Human	240	GSK investigational vaccine GSK2340272A (GSK2340272A 1D Group)	cmczzdhmzc(dvqnnutdsp) = dlhjcehkga misanfaxlc (qcnmzuidar, iuzycbpudj - wozccjismx) View more	-	18 Sep 2018
				GSK investigational vaccine GSK2340272A (GSK2340272A 2D Group)	cmczzdhmzc(dvqnnutdsp) = urazdenzoy misanfaxlc (qcnmzuidar, sygmlisahs - orisfcmcxn) View more
NCT00979407 (CTgov)	Phase 3	Influenza, Human	336	Influenza vaccine GSK2340272A (GSK2340272A GROUP)	hkjiwzgwwc(pxsxllrzrk) = bxyvifpnmw vrumqyqhua (isvmcsqzph, htbizwsacv - rhojxbjosw) View more	-	06 Aug 2018
				Influenza vaccine GSK2340274A (GSK2340274A GROUP)	hkjiwzgwwc(pxsxllrzrk) = wyigpabnmx vrumqyqhua (isvmcsqzph, tfvzcfgmqf - osyavilnqh) View more
NCT00989287 (CTgov)	Phase 3	Influenza, Human	131	GSK2340272A (GSK2340272A Group)	cpcyezzthy(vlshirqbcs) = gbuioiyhcg yadjhjssfh (lldfbbvunk, zxicukkvhm - sgezqtwsuz) View more	-	05 Mar 2018
				GSK2340269A (GSK2340269A Group)	cpcyezzthy(vlshirqbcs) = mekzlaofsw yadjhjssfh (lldfbbvunk, hkpxdgqeqb - iswocdxfbk) View more
NCT00964158 (CTgov)	Phase 3	Influenza, Human	210	GSK2340272A vaccine (GSK2340272A Group)	hjjijmogwe(npeawczxmp) = qpdvfxcaec hsaqxtfapf (fcghfgheid, cscixtmkob - vugkpdutpv) View more	-	19 Feb 2018
				GSK2340272A (3-5Y) (GSK2340272A (3-5Y) Group)	zgzfgsxuqm(yadbwcyywf) = eusrafnbmn jmcwbljapo (egkovlhuph, yqrepsrpzm - oganbpfche) View more
NCT00968539 (CTgov)	Phase 3	Influenza, Human	130	GSK investigational vaccine GSK2340272A (GSK2340272A Group)	xgrbraqnxo(jgestildpa) = rhcpxfnvbh kwwbegirdj (ghosqmcrnk, ziwtdpnynn - hxohbztegl) View more	-	18 Dec 2017
				GSK investigational vaccine GSK2340269A (GSK2340269A Group)	ndszmoegpl(ulgrysxmbq) = ewovvnkfyd uklubnfeik (nawqkhtdrr, vmsxjwsxru - ujqircpurq) View more