Delving into the Latest Updates on Influenza A virus H5N1 vaccine(Medicago, Inc.) with Synapse

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.

Start Date01 Sep 2012

Sponsor / Collaborator

Access To Advanced Health Institute

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NCT01244867 / CompletedPhase 2

A Phase 2, Randomized, Observer-blind, Single Center, Dose-Ranging Study to Evaluate the Immunogenicity Safety and Tolerability of the H5 VLP Influenza Vaccine With or Without Alhydrogel in Healthy Adults 18-60 Years of Age.

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

Start Date01 Nov 2010

Sponsor / Collaborator

Medicago, Inc.

[+1]

100 Clinical Results associated with Influenza A virus H5N1 vaccine(Medicago, Inc.)

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100 Translational Medicine associated with Influenza A virus H5N1 vaccine(Medicago, Inc.)

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100 Patents (Medical) associated with Influenza A virus H5N1 vaccine(Medicago, Inc.)

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45

Literatures (Medical) associated with Influenza A virus H5N1 vaccine(Medicago, Inc.)

31 Dec 2024·Human Vaccines & Immunotherapeutics

The economic rationale for cell-based influenza vaccines in children and adults: A review of cost-effectiveness analyses

Review

Author: Levin, Myron J ; Ruiz-Aragón, Jesús ; Urueña, Analia ; Fisman, David ; Postma, Maarten ; Mould-Quevedo, Joaquin F ; Nguyen, Van Hung ; Giglio, Norberto ; Pelton, Stephen I

Seasonal influenza significantly affects both health and economic costs in children and adults. This narrative review summarizes published cost-effectiveness analyses (CEAs) of cell-based influenza vaccines in children and adults <65 years of age, critically assesses the assumptions and approaches used in these analyses, and considers the role of cell-based influenza vaccines for children and adults. CEAs from multiple countries demonstrated the cost-effectiveness of cell-based quadrivalent influenza vaccines (QIVc) compared with egg-based trivalent/quadrivalent influenza vaccines (TIVe/QIVe). CEA findings were consistent across models relying on different relative vaccine effectiveness (rVE) estimate inputs, with the rVE of QIVc versus QIVe ranging from 8.1% to 36.2% in favor of QIVc. Across multiple scenarios and types of analyses, QIVc was consistently cost-effective compared with QIVe, including in children and adults across different regions of the world.

31 Dec 2024·Emerging Microbes & Infections

A single immunization with H5N1 virus-like particle vaccine protects chickens against divergent H5N1 influenza viruses and vaccine efficacy is determined by adjuvant and dosage

Article

Author: Ao, Xiang ; Fan, Huiying ; Kong, Dexin ; Qiu, Weihong ; Ye, Hejia ; Liao, Ming ; Wang, Jiaxin ; Zhu, Xiutong ; Chi, Lanyan ; He, Yanjuan

The H5N1 subtype highly pathogenic avian influenza virus (HPAIV) reveals high variability and threatens poultry production and public health. To prevent the spread of H5N1 HPAIV, we developed an H5N1 virus-like particle (VLP) vaccine based on the insect cell-baculovirus expression system. Single immunization of the H5N1 VLP vaccines induced high levels of HI antibody titres and provided effective protection against homologous virus challenge comparable to the commercial inactivated vaccine. Meanwhile, we assessed the relative efﬁcacy of different adjuvants by carrying out a head-to-head comparison of the adjuvants ISA 201 and ISA 71 and evaluated whether the two adjuvants could induce broadly protective immunity. The ISA 71 adjuvanted vaccine induced significantly higher levels of Th1 and Th2 immune responses and provided superior cross-protection against antigenically divergent H5N1 virus challenge than the ISA 201 adjuvanted vaccine. Importantly, increasing the vaccine dose could further enhance the cross-protective efficacy of H5N1 VLP vaccine and confer completely sterilizing protection against antigenically divergent H5N1 virus challenge, which was mediated by neutralizing antibodies. Our results suggest that the H5N1 VLP vaccine can provide broad-spectrum protection against divergent H5N1 influenza viruses as determined by adjuvant and vaccine dose.

01 Jan 2024·GMS hygiene and infection control

Cell-based influenza vaccines: An effective vaccine option for under 60-year-olds.

Review

Author: Schmidt, Kim J ; Wendt, Luise ; Wahle, Klaus ; Gärtner, Barbara C ; Schwarz, Tino F ; Förster, Laura-Christin ; Beier, Dietmar ; Gosch, Gunther

AimSeasonal influenza poses a significant burden of disease, affecting not only older adults but also individuals under the age of 60. It carries a high economic burden, mainly driven by influenza-associated productivity losses in the working population. Conventional egg-based influenza vaccines may have reduced effectiveness due to antigen adaptation in eggs. In contrast, cell-based influenza vaccines are less likely to be affected by such antigen adaptation. This review aims to present real-world data (RWD) comparing the effectiveness of quadrivalent cell-based (QIVc) and egg-based (QIVe) influenza vaccines over three consecutive seasons.MethodsA comprehensive review was conducted, analyzing RWD from retrospective cohort and case-control studies on the relative vaccine effectiveness (rVE) of QIVc versus QIVe during the 2017/18-2019/20 seasons.ResultsThis study included six retrospective cohort studies and one case-control study, with a combined total of approximately 29 million participants. A cohort study involving people aged ≥4 years during the 2017/18 season showed a statistically significant rVE of QIVc compared to QIVe in preventing influenza-like illness, with a value of 36.2%. QIVc demonstrated statistically significant superiority over QIVe in preventing outpatient and inpatient medical encounters as observed in two cohort studies conducted during the 2018/19 and 2019/20 seasons. The rVE of QIVc compared to QIVe was found to be 7.6% in individuals aged ≥4 years and 9.5% in individuals aged ≥18 years. Three additional cohort studies conducted between 2017/18-2019/20 reported a statistically significant improvement in rVE (5.3-14.4%) of QIVc compared to QIVe in preventing influenza-related hospitalizations and emergency department visits due to influenza in individuals aged 4-64 years. In a case-control study across all three seasons, QIVc showed statistically significantly higher effectiveness compared to QIVe in preventing test-confirmed influenza, with rVEs of 10.0-14.8%.ConclusionsRWD from the 2017/18-2019/20 seasons demonstrated that QIVc is more effective than QIVe in preventing influenza-related outcomes in individuals aged 4-64 years. Preferential use of cell-based influenza vaccines, as opposed to conventional egg-based vaccines, could reduce the burden of influenza-related symptoms on individuals and alleviate the economic impact on the German population under 60 years of age.

100 Deals associated with Influenza A virus H5N1 vaccine(Medicago, Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza in Birds	Phase 2	-	Infectious Disease Research Institute	-
influenza A subtype H5N1 infection	Discovery	US	Medicago, Inc.	01 Sep 2012
Influenza A virus infection	Discovery	CA	Medicago, Inc.	21 Nov 2010
Influenza in Birds	Discovery	-	Medicago, Inc.	-