Delving into the Latest Updates on Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), GSK-1562902A

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK PlcGlaxoSmithKline Biologicals SA

License Organization-

Drug Highest PhaseWithdrawn

First Approval Date

European Union (14 May 2008),

Influenza, Human

Regulation-

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This open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 μg doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine (A/Vietnam/1194/2004; clade 1) (NCT00449670). The aim of the extension study was to evaluate different timings for heterologous AS03A-adjuvanted booster vaccination (A/Indonesia/5/2005; clade 2.1) given at Month 6, 12, or 36 post-primary vaccination. Immunogenicity was assessed 21 days after each booster vaccination and the persistence of immune responses against the primary vaccine strain (A/Vietnam) and the booster strain (A/Indonesia) was evaluated up to Month 48 post-primary vaccination. Reactogenicity and safety were also assessed.

RESULTS:

After booster vaccination given at Month 6, HI antibody responses to primary vaccine, and booster vaccine strains were markedly higher with one dose of AS03A-H5N1 booster vaccine in the AS03A-adjuvanted primary vaccine group compared with two doses of booster vaccine in the non-adjuvanted primary vaccine group. HI antibody responses were robust against the primary and booster vaccine strains 21 days after boosting at Month 12 or 36. At Month 48, in subjects boosted at Month 6, 12, or 36, HI antibody titers of ≥1:40 against the booster strain persisted in 39.2%, 61.2%, and 95.6% of subjects, respectively. Neutralizing antibody responses and cell-mediated immune responses also showed that AS03A-H5N1 heterologous booster vaccination elicited robust immune responses within 21 days of boosting at Month 6, 12, or 36 post-primary vaccination. The booster vaccine was well tolerated, and no safety concerns were raised.

CONCLUSIONS:

In Asian adults primed with two doses of AS03A-adjuvanted H5N1 pandemic influenza vaccine, strong cross-clade anamnestic antibody responses were observed after one dose of AS03A-H5N1 heterologous booster vaccine given at Month 6, 12, or 36 after priming, suggesting that AS03A-adjuvanted H5N1 vaccines may provide highly flexible prime-boost schedules. Although immunogenicity decreased with time, vaccinated populations could potentially be protected for up to three years after vaccination, which is likely to far exceed the peak of the a pandemic.

01 Jun 2009·Current opinion in molecular therapeutics

GSK's novel split-virus adjuvanted vaccines for the prevention of the H5N1 strain of avian influenza infection.

Article

Author: Jones, Taff

Although influenza pandemics occur infrequently, they are unpredictable. Given that humans had not been previously exposed to the novel H5N1 strain, few (if any) individuals have any degree of immunity to the strain. GlaxoSmithKline plc (GSK) has developed two inactivated split H5N1 vaccines adjuvanted with GSK's proprietary oil-in-water emulsion AS03: GSK-1562902A (produced in Dresden, Germany) and GSK-1557484A (produced in Québec, Canada). The vaccines principally use an A/Vietnam strain virus; following the vaccination of influenza-naïve ferrets, potent neutralizing titers against the homologous A/Vietnam strain virus and against a heterologous A/Indonesia strain virus were elicited. In phase I, II and III clinical trials, two administrations of low doses (3.8 microg) of the vaccines induced protective immunity in more than 90% of vaccinees. The vaccines were generally well tolerated; the most frequently reported local adverse event was pain at the injection site. The vaccines, which can be administered in the pre-pandemic and pandemic setting, were approved in Europe in May 2008 as Prepandrix and Pandemrix, respectively. Phase II/III trials were also ongoing at the time of publication for both GSK-1562902A and GSK-1557484A. With the enormous demand for an effective vaccine in the event of an H5N1 pandemic, GSK's inactivated split H5N1 virus vaccine likely will be a highly valued product.

01 Nov 2008·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Article

Author: Moral, M A ; Tomillero, A

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Perillyl alcohol, Perphenazine 4-aminobutyrate, PeviPRO/breast cancer, PF-03814735, PHA-739358, Pimecrolimus, Plitidepsin, Posaconazole, Prasterone, Prasugrel, Pregabalin, Prucalopride, PRX-08066; rAAV2-TNFR:Fc, Ranelic acid distrontium salt, Ranibizumab, rCD154-CLL, Retapamulin, RTS,S/SBAS2, rV-PSA-TRICOM/rF-PSA-TRICOM; SG-2000, Sinecatechins, Sirolimus-eluting stent, Sorafenib, SP-1640, Strontium malonate, Succinobucol, Sunitinib malate; Taxus, Teduglutide, Telavancin hydrochloride, Telbivudine, Telmisartan/hydrochlorothiazide, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ustekinumab; V-5 Immunitor, Voriconazole, Vorinostat; Xience V, XL-184, XL-647, XL-765; Y-39983, Zibotentan.

1

News (Medical) associated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc)

05 Mar 2012

·medcitynews.com

GSK files for approval on two new influenza vaccines

GlaxoSmithKline‘s (NYSE:GSK) activity on the vaccine front continues as the pharma giant seeks regulatory approval on two new influenza vaccines. Britain-based GSK filed a biologics license application with the U.S. Food and Drug Administration that seeks approval for a vaccine targeting the H5N1 pandemic influenza. The vaccine, called Pumarix, is already approved in Europe. GSK’s H5N1 vaccine program was supported by a contract with the Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services. GSK has also filed for U.S. and European regulatory approval on a new influenza vaccine that targets four strains of the virus. The GSK filing for its quadrivalent vaccine comes on the heels of AstraZeneca (NYSE:AZN) subsidiary MedImmune’s FDA approval last week on a quadrivalent vaccine for its immunization product FluMist. A quadrivalent vaccines provides immunity against two strains each of influenza virus types A and B. GSK, which has its U.S headquarters in Research Triangle Park, North Carolina, has become more active in vaccine development following its $1.4 billion acquisition of Canada-based vaccines company ID Biomedical in 2005. That deal brought to GSK ID Biomedical facilities in Canada, the United States and Germany. GSK last week announced a joint venture with Japanese pharma company Daiichi-Sankyo to form what could become the largest vaccines company in Japan.

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100 Deals associated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc)

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External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	European Union	GlaxoSmithKline Biologicals SA	14 May 2008
Influenza, Human	Iceland	GlaxoSmithKline Biologicals SA	14 May 2008
Influenza, Human	Liechtenstein	GlaxoSmithKline Biologicals SA	14 May 2008
Influenza, Human	Norway	GlaxoSmithKline Biologicals SA	14 May 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00652743 (CTgov)	Phase 3	Influenza, Human	845	GSK1562902A+Pandemic influenza vaccine (GSK1562902A M12 Group)	bykxjtuhhv = nbinnscqyk unyyvuakzf (ucdlvzjuls, vhfnnthcyt - yyzvflbdiv) View more	-	02 Aug 2018
				GSK1562902A+Pandemic influenza vaccine (GSK1562902A M36 Group)	sjbtimbcxg = eyqlbxizjh pyidalddhi (hvxwcxlprb, gvlfcbllln - qofdjdnlun) View more
NCT00506350 (CTgov)	Phase 2	Influenza, Human	350	Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F1 Primed Group)	bexunfhefw(etiacdrqjy) = raoemoymkv twrhxbvzlx (ctpgxtikkw, rhhvlztamq - ykvjmhtizs) View more	-	04 Oct 2017
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	bexunfhefw(etiacdrqjy) = mkigcqavwm twrhxbvzlx (ctpgxtikkw, qawidyaimz - tlezwrcuzb) View more
NCT00812981 (CTgov)	Phase 3	Influenza, Human	320	GSK1562902A (1562902A NP Group)	lmopalfrxl(gkcturctqd) = oftnlcmsmu fyunssxvml (urorvaxybe, ktlikstxxe - lqxlfwcjuf) View more	-	16 Jun 2017
				GSK1562902A (1562902A CP Group)	lmopalfrxl(gkcturctqd) = tioivjrtau fyunssxvml (urorvaxybe, khtasbraxc - bydmdqhpcp) View more
NCT01730378 (CTgov)	Phase 4	Influenza, Human	131	Prepandrix™ (Prepandrix Group)	vgheosrtlb = gstnzkdwgw gcbandlkuk (uvnggyiqui, gjiybdnaxv - rbavtrybot) View more	-	24 Dec 2014
				Fluarix™ (Fluarix Group)	xizhtaojgq(dvkjpyejsw) = ocliyodnsj xecsqwnxjh (ilcywiohqx, bmjhwbwaxo - pehsyttbwe) View more
NCT00449670 (Pubmed) Manual	Phase 3	influenza A subtype H5N1 infection	1,206	AS03A-adjuvanted heterologous H5N1 vaccines	hrfqfoafzv(xcwcdatfrk) = in subjects boosted at Month 6, 12, or 36, HI antibody titers of ≥1:40 against the booster strain persisted in 39.2%, 61.2%, and 95.6% of subjects, respectively. friursxwwz (umkbktznxc ) View more	Positive	01 Dec 2014
NCT00510874 (CTgov)	Phase 1	Influenza, Human	780	Pumarix™ (Pumarix Formulation 1 Group)	remzmionfe = scdwfigslz qdorrvzzfi (qwugvggreb, fivrkcmxeu - jtcosqlcqt) View more	-	07 Feb 2014
				Pumarix™ (Pumarix Formulation 2 Group)	remzmionfe = gfcdijqhqc qdorrvzzfi (qwugvggreb, xfjvbzuogv - zbsvuynhwt) View more
NCT00397215 (CTgov)	Phase 2	Influenza, Human	437	Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 1 Group)	jqjyrvurcb(suexwmlhhb) = vwzvnfoeeq oimkooeihn (fedajfoipz, jpalrkwuet - sfalxcmpao) View more	-	20 May 2013
				Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 2 Group)	jqjyrvurcb(suexwmlhhb) = wgcitnbraa oimkooeihn (fedajfoipz, ppmlukaxtq - iofuomywrg) View more