Delving into the Latest Updates on Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

PanBlok H7

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication

Influenza in Birds

Originator Organization

Vaxine Pty Ltd.

Active Organization

Sanofi Pasteur

Inactive Organization

Vaxine Pty Ltd.

Rho, Inc.

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older

VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.
The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.
The study duration for each participant will be approximately 13 months.

Start Date03 Nov 2022

Sponsor / Collaborator

Sanofi Pasteur

NCT03283319

/ CompletedPhase 2IIT

Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Start Date20 Sep 2017

Sponsor / Collaborator

Biomedical Advanced Research and Development Authority (BARDA)

[+1]

NCT03038776

/ CompletedPhase 1

A Randomised, Controlled, Phase 1 Study in Healthy Adults to Evaluate the Immunogenicity and Safety of a Recombinant H7 Hemagglutinin Influenza Vaccine

Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine, namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine

Start Date01 Jan 2017

Sponsor / Collaborator

Vaxine Pty Ltd.

100 Clinical Results associated with Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)

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100 Translational Medicine associated with Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)

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100 Patents (Medical) associated with Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)

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1

Literatures (Medical) associated with Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)

npj VaccinesQ1 · MEDICINE

Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults

Q1 · MEDICINE

ArticleOA

Author: Oshansky, Christine M ; Johnson, Robert A ; Cioce, Vittoria ; Lu, Di ; Horwith, Gary ; Chen, Li-Mei ; Jepson, Brett ; Treanor, John J ; Donis, Ruben O ; Pavetto, Corrina ; Zhou, James ; Bright, Rick A ; Nguyen, Bai ; King, James ; Biscardi, Karen

AbstractAn unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016–2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on the findings of a clinical study in healthy adults designed to evaluate the safety and immunogenicity of three dose levels of recombinant influenza vaccine derived from highly pathogenic A/Guangdong/17SF003/2016 (H7N9) virus adjuvanted with AS03 or MF59 oil-in water emulsions. Most of the six study groups meet the FDA CBER-specified vaccine licensure criterion of 70% seroprotection rate (SPR) for hemagglutination inhibition antibodies to the homologous virus. A substantial proportion of subjects show high cross-reactivity to antigenically distinct heterologous A(H7N9) viruses from the first epidemic wave of 2013. These results provide critical information to develop a pandemic response strategy and support regulatory requirements for vaccination under Emergency Use Authorization.

100 Deals associated with Recombinant H7 Hemagglutinin Influenza Vaccine(Vaxine Pty Ltd)

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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	Discovery	United States	Rho, Inc.	20 Sep 2017
Influenza in Birds	Discovery	Australia	Vaxine Pty Ltd.	01 Jan 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05608005 (CTgov)	Phase 1/2	Influenza, Human	581	Panblok H7+MF59 (Group 1: Panblok H7 (7.5 mcg) + MF59)	rlveroxfal(hmblvjqmbn) = jiobtdanrk jrhunosfss (uyokyvhvjb, qoqborapyw - mtjgqieigo) View more	-	20 Feb 2025
				Panblok H7+MF59 (Group 2: Panblok H7 (15 mcg) + MF59)	rlveroxfal(hmblvjqmbn) = ixywcrcrkh jrhunosfss (uyokyvhvjb, zsbtlofcka - pwubmhtcxh) View more
NCT02464163 (PSC26, CTgov)	Phase 1/2	Influenza, Human	407	Panblok+rHA adjuvant (Panblok 7.5µg in 2% SE)	lrenuprnml(wuljlnlbcg) = mvyvkqjnhv gsuntifkmo (mlqtknrypm, zzlyqwsoyl - dujdsnqvib) View more	-	26 Oct 2017
				Panblok+rHA adjuvant (Panblok 15µg in 2% SE)	lrenuprnml(wuljlnlbcg) = wicqvhvcgx gsuntifkmo (mlqtknrypm, gzsxzjhiwo - viusakbxll) View more