Delving into the Latest Updates on Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

AREPANRIX, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

influenza A subtype H5N1 infectionInfluenza A virus infectionInfluenza, Human

Originator Organization

ID Biomedical Corporation of Quebec

Active Organization-

Inactive Organization

GSK PlcID Biomedical Corporation of Quebec

License Organization-

Drug Highest PhaseWithdrawn

First Approval Date

United States (22 Nov 2013),

influenza A subtype H5N1 infection

Regulation-

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In retrospective observational studies, an increased relative risk of incident narcolepsy was observed in some European countries among recipients of the AS03-adjuvanted, A(H1N1)pdm09, inactivated, detergent-split virion vaccine Pandemrix™ manufactured in Dresden, Germany (D-Pan H1N1). A similar increased risk was not observed in a retrospective population-based study in individuals in Quebec province, Canada, who received Aprepanrix™, a Quebec-manufactured AS03-adjuvanted A(H1N1)pdm09 inactivated, detergent-split virion vaccine (Q-Pan H1N1). Antibody responses in D-Pan versus Q-Pan vaccinees (adults/children) measured as hemagglutination inhibition (HI) titers 21 d post-vaccination were found to be equivalent (NCT01161160). The current post-hoc analysis was conducted to determine whether antibody avidity differed following immunization with the 2 vaccines. Using surface plasmon resonance, we evaluated the capacity of serum specimens (drawn from the comparative immunogenicity trial) from a subset of subjects aged 3-9 y who received either D-Pan or Q-Pan (N = 28/group), to bind to recombinant A(H1N1)pdm09 hemagglutinin. IgG antibodies were purified from Day 21 sera. Binding was assessed by end association level; dissociation by retention of antigen-antibody complexes at the end of the dissociation phase, and kd. Inter-run variability for the control monoclonal antibody, association levels and dissociation levels was low (CVs 1.3%, 7.8% and 1.4%, respectively); non-specific binding was negligible. High avidity and slow dissociation was observed for both groups (kd ≤ 10(-4)/s; geometric mean [IQR] association and dissociation levels for D-Pan/Q-Pan: 15.4 RU [13.4-17.7]/12.4 RU [10.8-14.3] and 94.5% [92.5-96.5]/95.5% [93.5-97.6], respectively). Association, but not dissociation levels correlated with HI titers. No significant differences in avidity parameters were observed between D-Pan and Q-Pan sera.

01 Jan 2012·HIV Clinical Trials

High-Level Immunogenicity Is Achieved Vaccine With Adjuvanted Pandemic H1N1<sub>2009</sub> and Improved With Booster Dosing in a Randomized Trial of HIV-Infected Adults

Article

Author: Walmsley, Sharon ; Cooper, Curtis ; Haase, David ; Klein, Marina ; Smith, Bruce ; Marty, Kimberley ; MacKinnon-Cameron, Donna ; Law, Barb ; Scheifele, David ; Halperin, Scott ; Li, Yan

BACKGROUNDMore severe influenza disease and poor vaccine immunogenicity in HIV-infected patients necessitate improved immunization strategies to maximize vaccine efficacy.METHODSA phase III, randomized trial was conducted at 4 Canadian sites. Two dosing strategies (standard dose vs standard dose plus booster on day 21) were assessed in HIV patients aged 20 to 59 years during the H1N1(2009) pandemic. A single antigen, inactivated split adjuvanted (AS03(A)) influenza vaccine (Arepanrix) was utilized. Serum hemagglutination inhibition (HAI) titres were assessed at days 21 and 42 and at month 6.RESULTS150 participants received at least one injection. Baseline parameters were similar between groups: 83% male, 85% on HAART, median CD4 = 519 cells/mm(3), 84% with HIV RNA < 50 copies/mL. At day 21, seroprotection (HAI ≥1:40) was achieved in 80% (95% CI, 70-89) of participants. Seroconversion occurred in 74% (63-85). Seroprotection and seroconversion were further improved in those randomized to booster dosing: day 42, 94% (85-98) versus 73% (60-83) (P < .01) and 86% (75-93) versus 66% (5-77) (P = .01). Seroprotec-tion was retained in 40% (28-54) of recipients at month 6 with trends toward greater retention of immunity in booster recipients.CONCLUSIONHigh-level immunogenicity was achieved with a single dose of this adjuvanted vaccine. Immunogenicity was further improved with booster dosing. Use of this adjuvanted vaccine and booster represent an important approach to increasing immunogenicity in this vaccine hypo-responsive population.

100 Deals associated with Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec)

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	Preclinical	United States	GSK Plc	22 Mar 2013
Influenza, Human	Preclinical	Canada	GSK Plc	23 Jan 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02719743 (CTgov)	Phase 2	Influenza, Human	185	Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A). (H5N1 Formulation 1 Group)	jwquoxnnou(arhfemzcic) = zszvlfzxzv ynsbysbgjw (qzguymixmr, ifoqqtcoga - snbdhhhdof) View more	-	03 Jun 2019
				Influenza A (H5N1) Virus monovalent vaccine+GSK1557484A (H5N1 Formulation 2 Group)	jwquoxnnou(arhfemzcic) = ekmhwxjdyn ynsbysbgjw (qzguymixmr, furamahxep - zfumslezwo) View more
NCT01788228 (CTgov)	Phase 3	Influenza A virus infection	50	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group)	(hrralvexyk) = vlsgozvjtv qtkzmiohhq (uncxeergem, viiupmprzp - yfhbdcackw) View more	-	07 Apr 2015
				Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group)	(hrralvexyk) = xsjchqhtix qtkzmiohhq (uncxeergem, hskospjnyw - xfksfkkbfi) View more
NCT01416571 (CTgov)	Phase 2	Influenza, Human	78	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	apoovawyei(gkxbmouxvf) = idmovrzlmv gvckqmhdti (tferzhalet, dyylsjeqnx - hrcsxjvsly) View more	-	16 Apr 2014