Delving into the Latest Updates on Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Adjupanrix, Influenza A virus vaccine H5N1, pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Biologicals SA

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

EU (10 Oct 2009),

Influenza, Human

Regulation-

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This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

Start Date01 Jul 2013

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

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NCT01379937 / CompletedPhase 3

Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

Start Date28 Jul 2011

Sponsor / Collaborator

GSK Plc

NCT01323946 / CompletedPhase 2

Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

Start Date18 Apr 2011

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

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8

Literatures (Medical) associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

01 Jun 2019·VaccineQ3 · MEDICINE

Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1

Q3 · MEDICINE

Article

Author: Kiselev, Oleg ; Seipelt, Joachim ; Nicolodi, Christina ; Wolschek, Markus ; Muster, Thomas ; Groiss, Franz

BACKGROUNDTraditional inactivated influenza vaccines are the type of vaccines that were most frequently developed for immunization against the highly pathogenic avian H5N1 influenza virus. However, clinical trials with inactivated influenza vaccines for H5N1 indicated that high doses and at least two immunizations are required for an effective immune response (Nicholson et al., 2001; Treanor, Campbell et al., 2006; Treanor, Schiff et al., 2006; Ehrlich et al., 2008). We investigated the safety and immunogenicity of a live attenuated H5N1 vaccine (delNS1-H5N1) lacking the interferon antagonist nonstructural protein 1 (NS1).METHODSWe conducted a double-blind, placebo-controlled, phase 1 study in healthy adult participants who were randomly assigned at a 2:1 ratio to receive two immunizations of delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID₅₀)/subject or 7.5 log10 TCID₅₀/subject, or placebo.RESULTSIntranasal vaccination with the live attenuated delNS1-H5N1 vaccine was safe and well tolerated. The most common adverse events identified were symptoms associated with mild influenza infections, such as increased body temperature (>37.0 °C), pharyngeal erythema, rhinitis and throat irritation, and were reported within 7 days after the first immunization. delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID₅₀/subject. Seroconversion occurred in 75% of study participants after only one immunization with 7.5 log10 TCID₅₀/subject. Vaccine-specific local IgA responses were observed in 41.7% of individuals that showed serum antibody responses after 2nd immunization.CONCLUSIONSWe show that vaccination with a live attenuated H5N1 influenza vaccine lacking NS1 is safe and induces significant levels of vaccine-specific antibodies even after one immunization. The safety and immunogenicity data indicate that delNS1-H5N1 has the potential to fulfil the unmet need for an effective influenza vaccine in pandemic situations. (ClinicalTrials.gov identifier NCT03745274).

01 Dec 2016·International Journal of Biological MacromoleculesQ1 · CHEMISTRY

Improvement of immune responses to influenza vaccine (H5N1) by sulfated yeast beta-glucan

Q1 · CHEMISTRY

Article

Author: Yang, Ruile ; Wang, Chunmei ; Wang, Mi ; Fei, Chenzhong ; Wang, Xiaoyang ; Zheng, Wenli ; Xue, Feiqun ; Zhang, Lifang ; Zhang, Keyu

In this study, the adjuvant activity of sulfated glucan from saccharomyces cerevisiae (_SGSC) was investigated. sGSC had molecular weight of 12.9kDa and degrees of sulfation of 0.16. The effects of _SGSC on the splenic lymphocyte cells of mice were measured in vitro. The results showed that _SGSC could significantly promote lymphocyte proliferation singly or synergistically with Con A and LPS, and stimulate the cells to secrete IL-2 and INF-γ. The adjuvant activity of _SGSC was researched in BALB/c mice inoculated with inactivated H5N1vaccine in vivo. The results showed that _SGSC could significantly enhance lymphocyte proliferation, effectively increase the percentage of CD4⁺ T cells, decrease the percentage of CD8⁺ T cells, and elevate the CD4⁺/CD8⁺ ratio; enhance the HI antibody titre, and promote the production of IL-2, INF-γ, IL-4 and IL-6 at medium level. These results indicated that sulfated glucan showed an excellent adjuvant effect on H5N1vaccine in a mouse model. Therefore, _SGSC could be used as an effective immune adjuvant for an inactivated H5N1vaccine.

01 May 2016·VirologyQ3 · MEDICINE

A cationic liposome–DNA complexes adjuvant (JVRS-100) enhances the immunogenicity and cross-protective efficacy of pre-pandemic influenza A (H5N1) vaccine in ferrets

Q3 · MEDICINE

Article

Author: Lewis, David B ; Liu, Feng ; Lu, Xiuhua ; Fairman, Jeffery ; Tumpey, Terrence M ; Katz, Jacqueline M ; Sun, Xiangjie ; Levine, Min

Influenza A (H5N1) viruses continue to pose a public health threat. As inactivated H5N1 vaccines are poorly immunogenic, adjuvants are needed to improve the immunogenicity of H5N1 vaccine in humans. Here, we investigated the immunogenicity and cross-protective efficacy in ferrets of a clade 2.2-derived vaccine with addition of JVRS-100, an adjuvant consisting of cationic liposome-DNA complexes (CLDC). After the first vaccination, significantly higher levels of hemagglutination-inhibition (HAI) and neutralizing antibody titers were detected in ferrets immunized with adjuvanted vaccine compared to unadjuvanted vaccine. Following a second dose of adjuvanted vaccine, HAI antibody titers of ≥ 40 were detected against viruses from multiple H5N1 clades. HAI antibodies against newly isolated H5N2 and H5N8 viruses were also augmented by JVRS-100. Ferrets were challenged with a heterologous H5N1 virus. All ferrets that received two doses of adjuvanted vaccine exhibited mild illness, significantly reduced nasal wash virus titers and protection from lethal challenge. In contrast, ferrets that received unadjuvanted vaccine showed greater weight loss, high viral titers and 3 of 6 animals succumbed to the lethal challenge. Our results indicate that the addition of JVRS-100 to H5N1 vaccine enhanced immunogenicity and cross-protection against lethal H5N1 virus disease in ferrets. JVRS-100 warrants further investigation as a potential adjuvant for influenza vaccines.

1

News (Medical) associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

29 Jul 2022

·www.pmlive.com

GSK to supply 85 million doses of pandemic influenza vaccine to EU

GSK has signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of its pandemic influenza vaccine, Adjupanrix, to support pandemic preparedness in Europe. The contract is one of the first signed by HERA since it was launched by the EC in September 2021 with a mission to ‘prevent, detect and rapidly respond to health emergencies’. Roger Conner, president of Vaccines and Global Health at GSK, said: “I’m delighted that HERA has chosen GSK as a key partner in pandemic flu preparedness… We have all seen the devastating human, economic and social consequences of a pandemic and the important part that vaccines are playing in helping us return to normal life. Through this agreement for 85 million doses, we can help the EU and European countries, as well as other countries and regions, be better prepared for future pandemics.” Adjupanrix is a vaccine for use in adults to protect against pandemic influenza and, according to the European Medicines Agency (EMA), should only be used once an influenza pandemic has been officially declared by the World Health Organization (WHO) or the EU. Adjupanrix is a ‘mock-up’ vaccine, a type of vaccine that can be developed to help with the management of a future pandemic. Before an influenza pandemic begins, the strain of flu virus involved is unknown, so the correct vaccine cannot be prepared in advance. Instead, a vaccine can be prepared that contains a strain of flu virus to which very few people are immune. This vaccine can then be tested in advance to see how people react to it, allowing for the prediction of how people will react when the flu strain causing the pandemic is included. GSK has signed a number of contracts this year under which the company could provide at least 200 million doses of the pandemic influenza vaccine to governments around the world. In February, the company extended its pandemic influenza vaccine stockpile contract with the US government. This was followed by a renewed agreement in June for supply of pandemic influenza vaccines to the World Health Organization (WHO) and a contract with the government of Canada in July for both seasonal and pandemic influenza vaccines.

Vaccine

100 Deals associated with Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Pandemic influenza vaccine (H5N1)(GlaxoSmithKline Plc)	J07BB02	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	EU	GlaxoSmithKline Biologicals SA	10 Oct 2009
Influenza, Human	LI	GlaxoSmithKline Biologicals SA	10 Oct 2009
Influenza, Human	NO	GlaxoSmithKline Biologicals SA	10 Oct 2009
Influenza, Human	IS	GlaxoSmithKline Biologicals SA	10 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	SG	GSK Plc	24 Mar 2007
Influenza, Human	Phase 3	HK	GSK Plc	24 Mar 2007
Influenza, Human	Phase 3	HK	GSK Plc	24 Mar 2007
Influenza, Human	Phase 3	SG	GSK Plc	24 Mar 2007
Influenza, Human	Phase 1	TW	GSK Plc	24 Mar 2007
Influenza, Human	Phase 1	TH	GSK Plc	24 Mar 2007
Influenza, Human	Preclinical	TW	GSK Plc	24 Mar 2007
Influenza, Human	Discovery	TH	GSK Plc	24 Mar 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01910519 (CTgov)	Phase 2	influenza A subtype H5N1 infection	50	AS03+Influenza A (H5N1) Virus Monovalent Vaccine (Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant)	zmhlhoysll(wahfjcucpw) = lfkranesfp rwucdkhdxx (mwscqhkmrj, xrkbmjyrjg - mptrmlazub) View more	-	12 Feb 2019
				AS03 (Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv)	zmhlhoysll(wahfjcucpw) = noldzyjuip rwucdkhdxx (mwscqhkmrj, srjownuzhn - hxnqoxmvtn) View more
NCT01323946 (CTgov)	Phase 2	Influenza, Human	113	GSK Biologicals' investigational vaccine GSK1562902A (GSK1562902A 6 to 12 M Group)	nmryzckxei(ovlhmairka) = dvrulgmeyy inoqcyckeo (feyjwxdkzs, focfnstums - bzjkooniad) View more	-	04 Feb 2019
				GSK Biologicals' investigational vaccine GSK1562902A (GSK1562902A 12 to 24 M Group)	nmryzckxei(ovlhmairka) = xsndzvcrfc inoqcyckeo (feyjwxdkzs, hpatqcfvkg - xfcjiorknl) View more
NCT00506350 (CTgov)	Phase 2	Influenza, Human	350	Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F1 Primed Group)	lsvudarflj(vbvygsssxc) = ekglaoddti jywkckatvt (sswpiqyqrd, pvloxrfdpn - oyihesqcet) View more	-	04 Oct 2017
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	lsvudarflj(vbvygsssxc) = bpdememclj jywkckatvt (sswpiqyqrd, kbpqfiarnj - pmpsvfrixf) View more
NCT01379937 (CTgov)	Phase 3	Influenza, Human	520	Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group)	gubjbebyxn(otinbniehp) = qbhlbogdxb dayictzven (njyzfqiuio, tubrmulywh - fckzfbsgbm) View more	-	26 Mar 2014
				Influenza vaccine GSK1562902A Formulation 2+Havrix™ Junior (GSK1562902A Formulation 2 - Havrix / Havrix Jr Group)	gubjbebyxn(otinbniehp) = xtwkxihevb dayictzven (njyzfqiuio, itvgrsjrrt - ijaafrejvj) View more
NCT00695669 (CTgov)	Phase 2	Influenza, Human	312	Influenza A (H5N1) Virus Monovalent Vaccine (Influenza A (H5N1) 1 Group)	zxzqjroanm(lqfuoheioa) = abfzyozvat xckyzvghfd (atfokhhjoq, uiegsxmkrx - fitqnwmyvz) View more	-	07 Feb 2014
				Influenza A (H5N1) Virus Monovalent Vaccine (Influenza A (H5N1) 2 Group)	zxzqjroanm(lqfuoheioa) = vssujpyofs xckyzvghfd (atfokhhjoq, vospdegfhs - xpoejbrwnh) View more