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-

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

EU (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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2

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

01 Jan 2013·Expert Opinion on Biological TherapyQ3 · MEDICINE

Aflunov®: a vaccine tailored for pre-pandemic and pandemic approaches against influenza

Q3 · MEDICINE

Review

Author: Del Giudice, Giuseppe ; Della Cioppa, Giovanni ; Rappuoli, Rino ; Fragapane, Elena

INTRODUCTIONAflunov is an egg-derived, subunit vaccine from Novartis Vaccines and Diagnostics containing 7.5 μg of hemagglutinin (HA) from the avian A/H5N1 virus and the oil-in-water adjuvant MF59.AREAS COVEREDAflunov behaves as a pre-pandemic vaccine. It has a good safety profile at all ages. At all ages, it induces high and persisting antibody titers and activation of HA-specific Th0/Th1 CD4(+) T cells, the levels of which correlate with the neutralizing antibody titers after a booster dose 6 months later. Aflunov triggers strong immunological memory, which persists for at least 6 - 8 years and can be rapidly boosted with a heterovariant vaccine strain, inducing very high neutralizing antibody titers within one week. These antibodies broadly and strongly cross-react with drifted H5N1 virus strains from various clades. Finally, the MF59 changes the pattern of HA recognition by antibodies that react with the HA1 more than with the HA2 region.EXPERT OPINIONThe available data show that Aflunov is a pre-pandemic vaccine suitable not only for stockpiling in case of a pandemic, but also before a pandemic is declared, with the ultimate objective of preventing the onset of an influenza pandemic.

01 Feb 2012·Expert Review of VaccinesQ2 · MEDICINE

Aflunov^®: a prepandemic influenza vaccine

Q2 · MEDICINE

Review

Author: Panatto, Donatella ; Lai, Piero Luigi ; Gasparini, Roberto ; Amicizia, Daniela

Influenza viruses are adept in human populations. Indeed, they have the capacity to evade the immune system through mechanisms of mutations (antigenic drift) and major variations in surface protein expression (antigenic shift). When a major change occurs, the risk of a human pandemic arises. Three influenza pandemics occurred during the 20th century, the most serious being the Spanish influenza. The last pandemic of the past century occurred in 1968, and the responsible virus infected an estimated 1-3 million people throughout the world. The first pandemic of the present century occurred in 2009 and was sustained by a H1N1 strain (A/California/07/09). In 1997, a novel avian influenza virus, H5N1, first infected humans in China. Since its emergence, the H5N1 virus has spread from Asia to Europe and Africa, resulting in the infection of millions of poultry and wild birds. So far, 522 human cases and 322 deaths have been reported by the WHO. Many studies have therefore been performed to obtain efficacious and safe H5N1 vaccines. One of these is Aflunov(®). Aflunov is a prepandemic monovalent A/H5N1 influenza vaccine adjuvanted with MF59 produced by Novartis Vaccines and Diagnostics. In nonclinical studies conducted in rabbits, Aflunov proved to be well-tolerated, did not cause maternal or embryo-fetal toxicity, was not teratogenic, and had no effects on postnatal development. In clinical studies, Aflunov proved safe and well-tolerated in infants, children, adolescents, adults and the elderly. In the same subjects, the vaccine elicited robust immunogenicity against both homologous (A/Vietnam/1194/2004 clade 1) and heterologous viral strains (for instance, A/Indonesia/05/2005 or A/Turkey/15/2006) and induced immunologic memory. Thus, in 2010, the CHMP issued a positive opinion on Aflunov and in January 2011 Aflunov was given marketing authorization. This vaccine could be very useful in the event of adaptation of the H5N1 virus to humans, which could cause a new pandemic.

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

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)(Seqirus GmbH)	J07BB02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
influenza A subtype H5N1 infection	EU	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	LI	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	IS	Seqirus Ltd.	28 Nov 2010
influenza A subtype H5N1 infection	NO	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	IS	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	LI	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	NO	Seqirus Ltd.	28 Nov 2010
Influenza in Birds	EU	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)	acejtgxfiq(uyycwusilo) = gjrtzfijue jqantdosel (nldedkxlcs, aoqgyxqvny - bsalegajxr) View more	-	28 Feb 2013
				eTIV_a+MF59-eH5N1 (Mixed)	acejtgxfiq(uyycwusilo) = kudnntpdsb jqantdosel (nldedkxlcs, qwvvekeuac - avavenrhdg) View more