Delving into the Latest Updates on Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

IVACFLU-A

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

influenza A subtype H5N1 infectionInfluenza A virus infectionInfluenza in Birds+ [1]

Originator Organization

Institute Vaccines Medical Biologicals

Active Organization-

Inactive Organization

Institute Of Vaccines And Medical Biologicals, VietnamInstitute Vaccines Medical Biologicals

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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BACKGROUNDA global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development of a pre-pandemic influenza vaccine was initiated in 2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam.METHODSThis was a Phase 2/3, double-blinded, randomized, placebo-controlled study to test the safety and immunogenicity of IVACFLU-A/H5N1 vaccine in healthy adults. Phase 2 was a dose selection study, in which 300 participants were randomized to one of the three groups (15 mcg, 30 mcg, or placebo). Safety and immunogenicity were assessed in all participants. In Phase 3, 630 participants were randomized to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 (15 mcg, n = 525) or placebo (n = 105). Safety was assessed in all Phase 3 participants and immunogenicity was measured in a subset of participants.RESULTSThe vaccine was well tolerated and most of the adverse events were mild and of short duration. Mild pain at the injection site was the most common adverse event seen in 60 percent of participants in the vaccine group in Phase 3. In Phase 2, both 15 mcg and 30 mcg doses were immunogenic, so the lower dose was selected for further testing in Phase 3. In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH). The seroprotection rates were 44 percent for HI, 41 percent for MN and 55 percent for SRH. The GMT ratio was 5.31 and 3.7 for HI and MN respectively; GMA was 4.75 for the SRH.CONCLUSIONThe IVACFLU A/H5N1 was safe and immunogenic. Development of this pandemic avian influenza vaccine is a welcome addition to the limited global pool of these vaccines. ClinicalTrials.gov register NCT02612909.

01 Dec 2010·VaccineQ3 · MEDICINE

Evaluation of the cellular immune responses induced by a non-adjuvanted inactivated whole virus A/H5N1/VN/1203 pandemic influenza vaccine in humans

Q3 · MEDICINE

Article

Author: Brian A. Crowe ; Gerald Aichinger ; P. Noel Barrett ; Hartmut Ehrlich ; Julia Singer ; Markus Müller ; Michael G. Schwendinger ; Katrin Koelling-Schlebusch ; Peter Brühl ; Markus Zeitlinger ; Otfried Kistner ; Andreas Pilz ; Marijan Gerencer

In the present study the homologous and heterologous type and subtype specific cellular immune response induced by a wild type inactivated whole virus H5N1 Influenza (A/Vietnam/1203/2004) vaccine was evaluated. Two immunizations with the Vero cell derived H5N1 influenza vaccine on Day 0 and Day 21 induced significant H5N1 vaccine specific and H5 haemagglutinin specific clade and cross-clade reactive CD4(+) T cell responses, which were maintained at significant levels for at least 6 months. The H5N1 vaccine specific response cross-reacted with the H1N1, but not with H3N2 or B seasonal Influenza strains. The vaccine significantly increased the number of H5N1 specific and H5 haemagglutinin specific memory B cells, 6 months after the primary immunization, however no H1N1 specific cross-reactivity was observed. Importantly, the inactivated whole virus H5N1 vaccine was just as effective in inducing CD4(+) T cell and memory B cell response in the elderly (60 years or over) as in the adult population (18-59 years).

100 Deals associated with Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals)

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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 3	Vietnam	Institute Of Vaccines And Medical Biologicals, Vietnam	07 Mar 2017
Influenza, Human	Phase 3	Vietnam	Institute Of Vaccines And Medical Biologicals, Vietnam	07 Mar 2017
influenza A subtype H5N1 infection	Phase 3	Vietnam	Institute Of Vaccines And Medical Biologicals, Vietnam	01 Jun 2014
Influenza A virus infection	Phase 3	-	Institute Vaccines Medical Biologicals	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02612909 (Pubmed \| Vaccine) Manual	Phase 2/3	-	930	IVACFLU-A/H5N1	zfyxrfzapd(yvtvyzzbzh) = gpebetexeu yevflygpqr (sqvljzwssw ) View more	Positive	05 Feb 2020
NCT02612909 (CTgov)	Phase 2/3	Influenza in Birds \| Influenza, Human	930	Placebo (Phase 2: Placebo)	qaagffztqg(qkulaxmjhc) = qngdisbllt rdijtgurnd (zqygjjmimf, koutxpaiul - ekzaiocrjv) View more	-	16 Apr 2019
				IVACFLU-A/H5N1 vaccine (Phase 2: Vaccine (15 mcg))	qaagffztqg(qkulaxmjhc) = dcvhcgavnl rdijtgurnd (zqygjjmimf, dzjzlxlrml - hvppmhbklo) View more
NCT01507779 (CTgov)	Phase 1	Influenza A virus infection	48	Placebo (Placebo)	drjajqpcui(fjkbfbkgil) = mjlvhabarg bymstelfkg (qeakvnhtbx, esopgfamxb - swzhdkbkjc) View more	-	27 Feb 2019
				IVACFLU (Influenza Vaccine)	drjajqpcui(fjkbfbkgil) = ohwwtjiscq bymstelfkg (qeakvnhtbx, haocbfywbo - kaarqfvcuv) View more