Delving into the Latest Updates on Influenza virus vaccine(ID Biomedical Corporation) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine

Synonyms

FluLaval trivalent, FluLaval-YB, FluSF

+ [7]

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 PlcID Biomedical Corporation of Quebec

License Organization-

Drug Highest PhaseWithdrawn

First Approval Date

Canada (31 Dec 1991),

Influenza, Human

Regulation-

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Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

Start Date14 Sep 2022

Sponsor / Collaborator

National Heart, Lung & Blood Institute

NCT02188810

/ Unknown statusPhase 1

A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of a Single Intramuscular Dose of a PAL Adjuvant (FB-631) Co-administered With Seasonal TIV (2013-2014) in Healthy Adults.

This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers.
The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.

Start Date01 Apr 2014

Sponsor / Collaborator

Folia Biotech, Inc.

NCT01878825

/ CompletedPhase 3

Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older.

Start Date18 Jul 2013

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Influenza virus vaccine(ID Biomedical Corporation)

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100 Translational Medicine associated with Influenza virus vaccine(ID Biomedical Corporation)

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100 Patents (Medical) associated with Influenza virus vaccine(ID Biomedical Corporation)

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9

Literatures (Medical) associated with Influenza virus vaccine(ID Biomedical Corporation)

01 Jan 2020·Vaccine

Novel calixarene-based surfactant enables low dose split inactivated vaccine protection against influenza infection

Article

Author: Traversier, Aurélien ; Boivin, Guy ; Champagne, Anne ; Jawhari, Anass ; Mandon, Elodie Desuzinges ; Dejean, Emmanuel ; Pizzorno, Andrés ; Lina, Bruno ; Hamelin, Marie Eve ; Rosa-Calatrava, Manuel

Influenza A viruses cause major morbidity and represent a severe global health problem. Current influenza vaccines are mainly egg-based products requiring the split of whole viruses using classical detergents such as Triton X-100, which implies certain limitations. Here, we report the use of the novel calixarene-based surfactant CALX133ACE as an alternative to classical detergents for influenza inactivated split vaccine preparation. We confirmed that CALX133ACE-based split HA antigens are fully functional and quantifiable by the "gold standard" method SRID. Additionally, as in the case of the Triton X-100-based split, the CALX133ACE-based split antigens are stable for at least 6 months at 4 °C. Moreover, immunization of mice with CALX133ACE-based split NYMC X-179A (H1N1) antigens harboring 10 to 30-fold less antigen than the commercialized trivalent inactivated vaccines Vaxigrip® or Fluviral® induced comparable efficient protection and neutralizing antibody responses against A(H1N1)pdm09 infection. Taken together, our results demonstrate for the first time the use of a calixarene-based detergent as an efficient splitting agent for the production of optimized influenza split antigens, paving the way for significant improvement in the vaccine manufacturing process, notably with regard to the current regulation on the prohibition of endocrine disruptors, such as Triton X-100.

17 May 2018·Clinical Infectious DiseasesQ1 · MEDICINE

A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients

Q1 · MEDICINE

Article

Author: Kumar, Deepali ; Natori, Yoichiro ; Ferreira, Victor ; Shiotsuka, Mika ; Humar, Atul ; Singer, Lianne ; Lilly, Les ; Slomovic, Jaclyn ; Hoschler, Katja ; Ashton, Peter ; Rotstein, Coleman ; Schiff, Jeffrey

BackgroundThe annual standard-dose (SD) influenza vaccine has suboptimal immunogenicity in solid organ transplant recipients (SOTRs). Influenza vaccine that contains higher doses of antigens may lead to greater immunogenicity in this population.MethodsWe conducted a randomized, double-blind trial to compare the safety and immunogenicity of the 2016-2017 high-dose (HD; FluzoneHD, Sanofi) vs SD (Fluviral, GSK) influenza vaccine in adult SOTRs. Preimmunization and 4-week postimmunization sera underwent strain-specific hemagglutination inhibition assay.ResultsWe enrolled 172 patients who received study vaccine, and 161 (84 HD; 77 SD) were eligible for analysis. Seroconversion to at least 1 of 3 vaccine antigens was present in 78.6% vs 55.8% in HD vs SD vaccine groups (P < .001), respectively. Seroconversions to A/ H1N1, A/H3N2, and B strains were 40.5% vs 20.5%, 57.1% vs 32.5%, and 58.3% vs 41.6% in HD vs SD vaccine groups (P = .006, P = .002, P = .028, respectively). Post-immunization geometric mean titers of A/H1N1, A/H3N2, and B strains were significantly higher in the HD group (P = .007, P = .002, P = .033). Independent factors associated with seroconversion to at least 1 vaccine strain were the use of HD vaccine (odds ratio [OR], 3.23; 95% confidence interval [CI], 1.56-6.67) and use of mycophenolate doses <2 g daily (OR, 2.76; 95% CI, 1.12-6.76).ConclusionsHD vaccine demonstrated significantly better immunogenicity than SD vaccine in adult transplant recipients and may be the preferred influenza vaccine for this population.Clinical Trials RegistrationNCT03139565.

01 Jan 2013·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Results of a randomized trial

Q3 · MEDICINE

Article

Author: Phac ; David W. Scheifele ; Scott A. Halperin ; Marc Dionne ; Otto G. Vanderkooi ; Curtis Cooper ; Brian J. Ward ; Yan Li

Many Canadians received a novel AS03-adjuvanted vaccine during the 2009 influenza A/H1N1 pandemic. Longer term implications of adjuvant use were unclear: would anti-H1N1 immune responses persist at high levels and, if so, could that result in increased or unusual adverse effects upon re-exposure to H1N1pdm09 antigen in the trivalent influenza vaccine (TIV) for 2010-11? To answer these questions, adults given AS03-adjuvanted H1N1pdm09 vaccine (Arepanrix®, GSK Canada) 9-10 mo earlier were enrolled in an evaluator-blinded, crossover trial to receive 2010-2011 non-adjuvanted TIV (Fluviral®, GSK Canada) and placebo 10 d apart, in random order. Adverse effects were monitored for 7 d after each injection. Vaccine-attributable adverse event (VAAE) rates were calculated by subtracting rates after placebo from those after vaccine. Blood was obtained pre-vaccination and 21-30 d afterward to measure hemagglutination inhibiting antibody titers. In total, 326 participants were enrolled and 321 completed the study. VAAE rates were low except for myalgia (18.6%) and injection site pain (63.2%). At baseline, H1N1pdm09 titers ≥ 40 were present in 176/325 subjects (54.2%, 95% confidence interval 48.6, 59.7), with a geometric mean titer (GMT) of 37.4 (95% CI 32.8, 42.6). Post-immunization, 96.0% (95% CI 92.3, 97.8) had H1N1pdm09 titers ≥ 40, with GMT of 167.4 (95% CI 148.7, 188.5). Responses to both influenza A strains in TIV were similar, implying no lasting effect of adjuvant exposure. In summary, titers ≥ 40 persisted in only half the participants 9-10 mo after adjuvanted pandemic vaccine but were restored in nearly all after TIV vaccination, with minimal increase in adverse effects.

100 Deals associated with Influenza virus vaccine(ID Biomedical Corporation)

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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, Human	Phase 2	Canada	ID Biomedical Corporation of Quebec	31 Dec 1991

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01878825 (CTgov)	Phase 3	Influenza, Human	121	Fluviral™ (Fluviral 18-60 Years Group)	feccvruaxn(vuherwnfah) = tzuietjbna gpycjyvqic (ncqmkgexks, bwgnxacdml - oiexouwlzm) View more	-	16 Jan 2015
				Fluviral™ (Fluviral >60 Years Group)	feccvruaxn(vuherwnfah) = kxglvzfvdc gpycjyvqic (ncqmkgexks, seqaldzugj - jlulawxkkp) View more
NCT01626820 (CTgov)	Phase 3	Influenza, Human	113	Fluviral® (Fluviral Adults Group)	bmgwesikix(koakonyaxb) = kbppjjfslk lglbjlyfxk (dwtuyxqihf, tdvuxzwvkz - tuppmjqiem) View more	-	14 Oct 2013
				Fluviral® (Fluviral Elderly Group)	bmgwesikix(koakonyaxb) = ymszcrppea lglbjlyfxk (dwtuyxqihf, mzlfyjdnmr - jzvqsiefxg) View more
NCT00980005 (CTgov)	Phase 3	Influenza, Human	2,116	GSK investigational vaccine GSK1557482A (Flulaval Group)	tyfmzavgqw(ggvsyxekwv) = jfmlfnifpb gmvtqhinmw (nrtshnbniv, jojtezktbe - jevromybab) View more	-	15 Feb 2012
				Fluzone® (Fluzone Group)	tyfmzavgqw(ggvsyxekwv) = gynkcndehg gmvtqhinmw (nrtshnbniv, invxhmpsve - jgbuajkxmb) View more
NCT01153685 (CTgov)	Phase 3	Influenza, Human	120	Fluviral® (Fluviral A Group)	cooqwqnjgo(phmkycstbq) = zspqfeccxq ukvstxnuib (saqmofqhhu, oruntrvapc - cmmemjbceh) View more	-	17 Nov 2011
				Fluviral® (Fluviral B Group)	cooqwqnjgo(phmkycstbq) = apixnogyvw ukvstxnuib (saqmofqhhu, cmqmuywgdq - tjjvjuldgp) View more
NCT00784784 (Stop-Flu-2, CTgov)	Phase 3	Influenza, Human	64	Fluviral (Influenza Vaccine)	lfaopbjada(xhpwhxqtnu) = bjpnmnrgcx aelnlgsiiy (cuzmuwbmxd, ryeolormsa - nsnbadccuk) View more	-	02 Sep 2011
				Zanamivir (Antiviral Prophylaxis)	lfaopbjada(xhpwhxqtnu) = fojfpcrqzc aelnlgsiiy (cuzmuwbmxd, meeidkuaqp - zehjieswkw) View more
NCT01001325 (CTgov)	Phase 3	Influenza, Human	468	Fluviral influenza vaccine, 2009-2010 (Seasonal Influenza Vaccination)	peymojplvk(hdpjibbjbe) = kkfaejxifz xufjzxhvfm (tlzsrhuvto, klraksgktk - ygydxczqfe) View more	-	15 Jun 2011
				Normal saline (Placebo)	peymojplvk(hdpjibbjbe) = yzphhclhvd xufjzxhvfm (tlzsrhuvto, trduzgjxkt - dptsqdkfrc) View more
NCT00929331 (CTgov)	Phase 3	Influenza, Human	110	Fluviral® (Fluviral Adult Group)	kwgbuxvtdl(csowgpkquu) = upekdtbhdy hgesfwsdsp (ijvbygjfjh, ovznldrclu - dbguodrdpo) View more	-	13 Aug 2010
				Fluviral® (Fluviral Elderly Group)	kwgbuxvtdl(csowgpkquu) = icbukillhj hgesfwsdsp (ijvbygjfjh, grpgudivot - qtukctuqie) View more
NCT00718120 (CTgov)	Phase 3	Influenza, Human	110	Fluviral® (Fluviral Adult Group)	rkbmyugbub(ylrvxvtviv) = ejmvznbqui jqnsfbmpaf (msasgnjwxq, rsczqrpqcb - bksghxfmsm) View more	-	25 Aug 2009
				Fluviral® (Fluviral Elderly Group)	rkbmyugbub(ylrvxvtviv) = vuxzneuope jqnsfbmpaf (msasgnjwxq, xsaywvsknl - fconluwfhu) View more
NCT00586469 (CTgov)	Phase 4	Influenza, Human	1,000	Fluviral (Old Bulk)	dfdpfokdxh(blxtlpdilm) = uflignfpjd iotuguulio (zjzdgomkwf, arnpwtdaih - avpwnrmzeo) View more	-	28 May 2009
				Fluviral (New Bulk)	dfdpfokdxh(blxtlpdilm) = pqeroviuri iotuguulio (zjzdgomkwf, njybvjmqev - nfgnwqfsmy) View more