Delving into the Latest Updates on Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Influenza A virus vaccine H5N1(Novartis Pharma AG), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

influenza A subtype H5N1 infectionInfluenza in Birds

Inactive Indication-

Originator Organization

Seqirus GmbH

Active Organization

Seqirus Ltd.

Inactive Organization

Novartis Vaccines & Diagnostics Srl

Drug Highest PhaseApproved

First Approval Date

European Union (28 Nov 2010),

influenza A subtype H5N1 infectionInfluenza in Birds

Regulation-

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Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines induce relatively strain-specific and short-lived antibody responses, annual immunisation with regularly updated vaccine is recommended for seasonal influenza, but would not be expected to protect against a pandemic event. In clinical trials among young adults, at least two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate antibody responses. However, studies including older subjects have unexpectedly found that some people aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and H9 respectively. These subjects mount a robust antibody response to single dose H5 or H9 pandemic vaccine, suggesting that they are effectively primed to at least some strains of avian influenza.
This exploratory proposal focuses on those elderly subjects whose immune systems already exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the immune response to seasonal and pandemic vaccination. We will examine neutralising antibody responses to a range of human and non-human influenza viruses before and after seasonal and pandemic vaccination and evaluate cellular B and T cell immune responses before and after pandemic H5 vaccination

Start Date01 Jan 2009

Sponsor / Collaborator

University Hospitals of Leicester

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NCT00814385

/ CompletedPhase 1/2IIT

A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine

This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.

Start Date01 Nov 2008

Sponsor / Collaborator

University Hospitals of Leicester

[+4]

JPRN-JMA-IIA00017

/ CompletedPhase 4IIT

Phase IV, Open-label Study to Assess the Durability and Cross-immunity of H5N1 influenza vaccine in Healthy Adult Japanese Volunteers

Start Date01 Aug 2008

Sponsor / Collaborator-

100 Clinical Results associated with Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)

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100 Translational Medicine associated with Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)

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100 Patents (Medical) associated with Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)

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25

Literatures (Medical) associated with Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)

18 Jan 2019·Avian DiseasesQ4 · AGRICULTURAL & FORESTRY SCIENCE

Efficacy of Clade 2.3.2 H5-Recombinant Baculovirus Vaccine in Protecting Muscovy and Pekin Ducks from Clade 2.3.4.4 H5N8 Highly Pathogenic Avian Influenza Infection

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Talaat, Shaimaa ; Kilany, Walid H ; Sultan, Hesham A ; Amarin, N ; Arafa, Abd-Elsatar ; Gaballa, Alaa A ; Elfeil, Wael K ; Shehata, Awad A

In late 2016, a highly pathogenic avian influenza (HPAI) virus subtype H5N8 clade 2.3.4.4 was reported in Egypt in migratory birds; subsequently, the virus spread to backyard and commercial poultry in several Egyptian governorates, causing severe economic losses to the poultry industry. Here, a recombinant subunit commercial H5 vaccine prepared from the clade 2.3.2 H5 segment on baculovirus was evaluated in Pekin ducks (Anasplatyrhynchos domesticus) and Muscovy ducks (Cairina moschata) in Biosafety Level 3 isolators by using two vaccination regimes: either a single dose on day 10 and a challenge on day 31 or a double dose on days 10 and 28 and a challenge on day 49. The protection parameters were evaluated after experimental infection with the Egyptian HPAI H5N8 isolate clade 2.3.4.4b (A/common-coot/Egypt/CA285/2016) based on mortality rate, clinical signs, gross lesions, seroconversion, virus shedding, and histopathologic changes. In the single-dose vaccination regime, the mortality rate in Muscovy and Pekin ducks was 10% and 0% vs. 40% and 0% in nonvaccinated challenged ducks, respectively. In the double-dose vaccination regime, the mortality rates in Muscovy and Pekin ducks were 0% and 0% vs. 60% and 40% in nonvaccinated challenged ducks, respectively. Muscovy ducks developed more severe clinical signs and gross lesions than Pekin ducks. In addition, tracheal viral shedding in challenged Muscovy ducks, in the single-dose vaccination regime, was 50%, 22%, and 0% at 3, 5, and 7 days postchallenge (DPC), respectively, and was 0% in all Pekin ducks vs. 100% in all challenged nonvaccinated Muscovy and Pekin ducks at 3, 5, and 7 DPC. The viral shedding in challenged Muscovy and Pekin ducks, in the double-dose vaccination regime, was 0% at 3, 5, and 7 DPC vs. 100% in nonvaccinated challenged Muscovy and Pekin ducks, respectively. The results of this study indicate that the H5 baculovirus-based vaccine can be used in ducks with better vaccination regime based on double-dose vaccination at 10 and 28 days of age. In addition, they highlight the need to evaluate the efficacy of currently used commercial vaccines against challenge with the newly emerged HPAI H5N8 clade 2.3.4.4 in the field in Egypt to ensure proper control strategy in ducks.

01 Dec 2018·Journal of Veterinary ResearchQ4 · AGRICULTURAL & FORESTRY SCIENCE

Inactivated H5 antigens of H5N8 protect chickens from lethal infections by the highly pathogenic H5N8 and H5N6 avian influenza viruses

Q4 · AGRICULTURAL & FORESTRY SCIENCE

ArticleOA

Author: Seo, Sang Heui ; Seo, Taehyun ; Jang, Yunyueng ; Jin, Myongha

AbstractIntroduction: Highly pathogenic Asian H5-subtype avian influenza viruses have been found in poultry and wild birds worldwide since they were first detected in southern China in 1996. Extensive control efforts have not eradicated them. Vaccination prevents such viruses infecting poultry and reduces the number lost to compulsory slaughter. The study showed the efficacy of inactivated H5 vaccine from the H5N8 virus against highly pathogenic H5N8 and H5N6 avian influenza viruses in chickens.Material and Methods: Reverse genetics constructed an H5 vaccine virus using the HA gene of the 2014 H5N8 avian influenza virus and the rest of the genes from A/PR/8/34 (H1N1). The vaccine viruses were grown in fertilised eggs, partially purified through a sucrose gradient, and inactivated with formalin. Chickens were immunised i.m. with 1 µg of oil-adjuvanted inactivated H5 antigens.Results: Single dose H5 vaccine recipients were completely protected from lethal infections by homologous H5N8 avian influenza virus and shed no virus from the respiratory or intestinal tracts but were not protected from lethal infections by heterologous H5N6. When chickens were immunised with two doses and challenged with homologous H5N8 or heterologous H5N6, all survived and shed no virus.Conclusion: Our results indicate that two-dose immunisations of chickens with H5 antigens with oil adjuvant are needed to provide broad protection against different highly pathogenic H5 avian influenza viruses.

01 Aug 2016·Journal of VirologyQ2 · MEDICINE

Mosaic H5 Hemagglutinin Provides Broad Humoral and Cellular Immune Responses against Influenza Viruses

Q2 · MEDICINE

Article

Author: Osorio, Jorge E. ; Kamlangdee, Attapon ; Kingstad-Bakke, Brock

ABSTRACTThe most effective way to prevent influenza virus infection is via vaccination. However, the constant mutation of influenza viruses due to antigenic drift and shift compromises vaccine efficacy. This represents a major challenge to the development of a cross-protective vaccine that can protect against circulating viral antigenic diversity. Using the modified vaccinia Ankara (MVA) virus, we had previously generated a recombinant vaccine against highly pathogenic avian influenza virus (H5N1) based on anin silicomosaic approach. This MVA-H5M construct protected mice against multiple clades of H5N1 and H1N1 viruses. We have now further characterized the immune responses using immunodepletion of T cells and passive serum transfer, and these studies indicate that antibodies are the main contributors in homosubtypic protection (H5N1 clades). Compared to a MVA construct expressing hemagglutinin (HA) from influenza virus A/VN/1203/04 (MVA-HA), the MVA-H5M vaccine markedly increased and broadened B cell and T cell responses against H5N1 virus. The MVA-H5M also provided effective protection with no morbidity against H5N1 challenge, whereas MVA-HA-vaccinated mice showed clinical signs and experienced significant weight loss. In addition, MVA-H5M induced CD8+T cell responses that play a major role in heterosubtypic protection (H1N1). Finally, expression of the H5M gene as either a DNA vaccine or a subunit protein protected mice against H5N1 challenge, indicating the effectiveness of the mosaic sequence without viral vectors for the development of a universal influenza vaccine.IMPORTANCEInfluenza viruses infect up to one billion people around the globe each year and are responsible for 300,000 to 500,000 deaths annually. Vaccines are still the main intervention to prevent infection, but they fail to provide effective protection against heterologous strains of viruses. We developed broadly reactive H5N1 vaccine based on anin silicomosaic approach and previously demonstrated that modified vaccinia Ankara expressing an H5 mosaic hemagglutinin prevented infection with multiple clades of H5N1 and limited severe disease after H1N1 infection. Further characterization revealed that antibody responses and T cells are main contributors to protection against H5N1 and H1N1 viruses, respectively. The vaccine also broadens both T cell and B cell responses compared to native H5 vaccine from influenza virus A/Vietnam/1203/04. Finally, delivering the H5 mosaic as a DNA vaccine or as a purified protein demonstrated effective protection similar to the viral vector approach.

100 Deals associated with Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)

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External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
influenza A subtype H5N1 infection	European Union	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	Liechtenstein	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	Iceland	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	Norway	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	Iceland	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	Liechtenstein	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	Norway	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	European Union	Seqirus Ltd.	28 Nov 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00481065 (CTgov)	Phase 2	Influenza in Birds \| Influenza, Human	405	eTIV_a+MF59-eH5N1 (Concomitant Alone)	boohmzrfjw(zxyjubmntf) = ztomqurlgz raijuqdciz (yrabdybydk, wbrjgtnsvj - iryclrkxzc) View more	-	28 Feb 2013
				eTIV_a+MF59-eH5N1 (Mixed)	boohmzrfjw(zxyjubmntf) = xpklfjbjzd raijuqdciz (yrabdybydk, krdaqxjayr - zhdgaxekae) View more