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)

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

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

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

01 May 2023·PLoS biology

Streptothricin F is a bactericidal antibiotic effective against highly drug-resistant gram-negative bacteria that interacts with the 30S subunit of the 70S ribosome.

Article

Author: Rodriguez, Shade ; Yu, Edward W ; Dowgiallo, Matthew G ; Truelson, Katherine A ; Manetsch, Roman ; Zulauf, Katelyn E ; Miller, Brandon C ; Kang, Yoon-Suk ; Kirby, James E ; Green, Alex B ; Smith, Kenneth P ; Morgan, Christopher E ; Chiaraviglio, Lucius ; Kang, Anthony D

The streptothricin natural product mixture (also known as nourseothricin) was discovered in the early 1940s, generating intense initial interest because of excellent gram-negative activity. Here, we establish the activity spectrum of nourseothricin and its main components, streptothricin F (S-F, 1 lysine) and streptothricin D (S-D, 3 lysines), purified to homogeneity, against highly drug-resistant, carbapenem-resistant Enterobacterales (CRE) and Acinetobacter baumannii. For CRE, the MIC50 and MIC90 for S-F and S-D were 2 and 4 μM, and 0.25 and 0.5 μM, respectively. S-F and nourseothricin showed rapid, bactericidal activity. S-F and S-D both showed approximately 40-fold greater selectivity for prokaryotic than eukaryotic ribosomes in in vitro translation assays. In vivo, delayed renal toxicity occurred at >10-fold higher doses of S-F compared with S-D. Substantial treatment effect of S-F in the murine thigh model was observed against the otherwise pandrug-resistant, NDM-1-expressing Klebsiella pneumoniae Nevada strain with minimal or no toxicity. Cryo-EM characterization of S-F bound to the A. baumannii 70S ribosome defines extensive hydrogen bonding of the S-F steptolidine moiety, as a guanine mimetic, to the 16S rRNA C1054 nucleobase (Escherichia coli numbering) in helix 34, and the carbamoylated gulosamine moiety of S-F with A1196, explaining the high-level resistance conferred by corresponding mutations at the residues identified in single rrn operon E. coli. Structural analysis suggests that S-F probes the A-decoding site, which potentially may account for its miscoding activity. Based on unique and promising activity, we suggest that the streptothricin scaffold deserves further preclinical exploration as a potential therapeutic for drug-resistant, gram-negative pathogens.

17 Feb 2023·ACS chemical biology

Profiling Sulfur(VI) Fluorides as Reactive Functionalities for Chemical Biology Tools and Expansion of the Ligandable Proteome

Article

Author: Kirkpatrick, Joanna M. ; Rittinger, Katrin ; Bush, Jacob T. ; Pogány, Peter ; Gilbert, Katharine E. ; Aatkar, Arron ; Vuorinen, Aini ; Burley, Glenn A. ; Grant, Emma K. ; House, David ; Pettinger, Jonathan

Here, we report a comprehensive profiling of sulfur(VI) fluorides (S^VI-Fs) as reactive groups for chemical biology applications. S^VI-Fs are reactive functionalities that modify lysine, tyrosine, histidine, and serine sidechains. A panel of S^VI-Fs were studied with respect to hydrolytic stability and reactivity with nucleophilic amino acid sidechains. The use of S^VI-Fs to covalently modify carbonic anhydrase II (CAII) and a range of kinases was then investigated. Finally, the S^VI-F panel was used in live cell chemoproteomic workflows, identifying novel protein targets based on the type of S^VI-F used. This work highlights how S^VI-F reactivity can be used as a tool to expand the liganded proteome.

19 May 2022·Case reports in ophthalmological medicine

Recurrence of Herpetic Keratitis after COVID-19 Vaccination: A Report of Two Cases

Author: Desilets, Jeffrey ; Patel, Sangita ; Fard, Ali Mahdavi

Background. Recurrence of herpetic keratitis following vaccination has been documented following vaccination with the Zostavax, trivalent flu, hepatitis A, and rabies vaccines. The USFDA and WHO have acknowledged that the novel COVID-19 vaccines similarly have a risk of reactive immunologic-based inflammation, namely, myositis, pericarditis, and Guillain-Barré syndrome. Case Presentation. We present two patients with latent herpetic keratitis who experienced reactivation of keratitis within weeks of COVID-19 vaccination despite prolonged periods of prior latency. A 52-year-old healthy male with no herpes simplex virus (HSV) keratitis recurrences in two years developed visual decline and patchy stromal haze within 24-48 hours of receiving the second Pfizer-BioNTech (COVID-19 BNT162b2) vaccine. A 67-year-old female with chronic neurotrophic keratitis developed her most severe exacerbation of herpes zoster keratitis in over 10 years occurring 2-3 weeks after her first Moderna (mRNA-1273) vaccine, which was later complicated by bacterial superinfection. Conclusions. The COVID-19 vaccines work by generating both adaptive humoral and cellular immune responses in humans, including elevation of anti-spike neutralizing antibody titers, antigen-specific CD4+ and CD8+ T-cell responses, and increased levels of proinflammatory cytokines such as interferon gamma (IFNγ). The general activation of the T-cell-mediated immune response and proinflammatory cytokines such as IFNγ may underlie the role of the COVID vaccines in reactivation of herpetic stromal keratitis and the clinical findings in our reported cases.

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

11 Jul 2024

·www.fiercepharma.com

Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season

According to CDC estimates, there were between 35 million and 65 million U.S. cases of the flu between October 2023 and June 2024. The dog days of summer might be in full swing, but for flu vaccine makers, its a busy time prepping for this fall's influenza season. CSL Seqirus said it kicked off influenza vaccine shipments on July 9, when it began to ship out its three options, according to a press release. The company’s portfolio includes unique offerings such as Flucelvax, the “first and only” cell-based influenza vaccine and Fluad, which is recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) for people 65 and older. CSL Seqirus also makes the egg-based vaccine Afluria for people six months of age and older. "As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes,” the drugmaker’s chief health officer, Gregg Sylvester, M.D., said in a statement. Last flu season in the U.S. saw significant decreases in vaccination rates and a spike in influenza-related hospitalizations and deaths, CSL Seqirus said, citing preliminary CDC estimates. Sanofi, for its part, said it began its initial vaccine shipments on July 10, with more planned through October. Sanofi’s 2024/2025 flu vaccine portfolio includes its Flublok—a quadrivalent shot that's made using insect cells—as well as standard and high-dose versions of its Fluzone. GSK said it started shipping its doses on July 11 following a licensing and lot-release approval from the FDA, according to a release. The company said it “worked quickly” to get doses produced and shipped after vaccine strain recommendations were made in February. GSK markets Flulaval and Fluarix and expects to distribute more than 36 million doses in the U.S. this flu season. It takes about two weeks after vaccination for antibodies to develop to combat flu, so vaccination is recommended ahead of the season, according to CSL Seqirus. That would ideally be in September or October for those who need only one dose, the CDC says. The CDC advises all eligible people who are six months and older receive an annual vaccine, especially those at an increased risk of severe complications, including older adults, pregnant people and children under five years old.

VaccineDrug ApprovalEmergency Use Authorization

11 Jul 2024

·www.biospace.com

GSK Begins Shipping Influenza Vaccine Doses for 2024-25 Season

GSK supports annual flu immunization by getting FLULAVAL and FLUARIX to patients in advance of flu season PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2024-25 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA). In February 2024, the World Health Organization (WHO) recommended the removal of B/Yamagata strains from seasonal influenza vaccines.1 The WHO recommends that egg-based trivalent vaccines for the 2024-2025 northern hemisphere influenza season contain the following:1 A/Victoria/4897/2022 (H1N1)pdm09-like virus A/Thailand/8/2022 (H3N2)-like virus B/Austria/1359417/2021 (B/Victoria lineage)-like virus In partnership with regulatory bodies, GSK worked quickly to ensure production, approval and availability of trivalent influenza vaccines with the recommended composition for the 2024-25 flu season. GSK expects to distribute over 36 million doses of its trivalent influenza vaccines in the US this season. Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months of age and older. According to the US Centers for Disease Control and Prevention (CDC), annual influenza vaccination is the best way to help protect against the flu. Ideally, vaccination should occur by the end of October, but people should continue to get vaccinated as long as the flu poses a threat.2 CDC recommends an annual flu vaccination for anyone aged six months or older who does not have contraindications.2 CDC estimates that from October 1, 2023, through June 15, 2024, there have been 35 – 65 million flu illnesses, 390,000 – 830,000 flu hospitalizations and 25,000 – 72,000 flu deaths.3 About Influenza The flu (influenza) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat and sometimes the lungs. It can cause mild to severe illness and at times can lead to death.4 Anyone can get the flu, however, it can be serious for young children, adults 65 years and older, pregnant women and people with pre-existing chronic health conditions, such as asthma, diabetes and heart disease.5 For more information about the flu, visit . Indication for FLUARIX and FLULAVAL FLUARIX and FLULAVAL are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccines. FLUARIX and FLULAVAL are approved for use in persons aged 6 months and older. Important Safety Information for FLUARIX and FLULAVAL Do not administer FLUARIX or FLULAVAL to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX or FLULAVAL should be based on careful consideration of the potential benefits and risks. Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX and FLULAVAL. Procedures should be in place to avoid injury from fainting. Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUARIX and FLULAVAL. If FLUARIX or FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons. The most common solicited local adverse reactions with FLUARIX in adults were pain and redness, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 5 through 17 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 3 through 4 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children aged 6 through 35 months who received FLUARIX QUADRIVALENT, the most common solicited local adverse reactions were pain and redness, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. The most common solicited local adverse reactions with FLULAVAL in adults were pain, redness, and swelling, and the most common solicited systemic adverse reactions were fatigue, headache, and muscle aches/arthralgia. In children aged 3 through 17 years, the most common solicited local adverse reaction was pain. In children aged 3 through 4 years, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children aged 5 through 17 years, the most common solicited systemic adverse reactions were muscle aches, headache, and fatigue. In children aged 6 through 35 months who received FLULAVAL QUADRIVALENT, the most common solicited local adverse reaction was pain, and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. Vaccination with FLUARIX or FLULAVAL may not result in protection of all vaccine recipients. Please see full Prescribing Information for FLUARIX and for FLULAVAL. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q1 Results for 2023 and any impacts of the COVID-19 pandemic. References 1. World Health Organization. Recommendations announced for influenza vaccine composition for the 2024-2025 northern hemisphere influenza season. Available at: . Accessed June 17, 2024. 2. Centers for Disease Control and Prevention. Influenza (Flu) Preventative Actions. Available at: . Accessed June 17, 2024. 3. Centers for Disease Control and Prevention. 2023-2024 Preliminary In-Season Burden Estimates. Available at: . Accessed June 17, 2024. 4. Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). Available at: . Accessed June 17, 2024. 5. Centers for Disease Control and Prevention. About Flu. Available at: . Accessed June 14, 2024. View source version on businesswire.com: Contacts GSK inquiries Media: Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Nick Stone +44 (0) 7717 618834 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Josh Williams +44 (0) 7385 415719 (London) Camilla Campbell +44 (0) 7803 050238 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia) Source: GSK plc View this news release online at:

VaccineDrug Approval

18 Jul 2022

·endpts.com

GSK nets a deal with Canadian government for flu vaccine manufacturing

While Covid-19 and monkeypox manufacturers are getting more ontracts, the Canadian government is still concerned with the flu, especially as its season will soon be upon North America in a few months. Last Friday, GSK announced an agreement with the Canadian government to manufacture pandemic and seasonal influenza vaccines. The four-year agreement, which extends through March 2026, includes GSK supplying as many as 80 million doses of Arepanrix, an adjuvanted pandemic flu vaccine, in case there is an influenza pandemic. The deal will also have GSK produce a minimum of 4 million doses per year of the seasonal flu vaccine Flulaval Tetra. Both vaccines will be manufactured at its 230,000-square-foot facility in Sainte-Foy, Quebec.

VaccineCollaborate

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

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KEGG	Wiki	ATC	Drug Bank
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Indication	Country/Location	Organization	Date
Influenza, Human	CA	ID Biomedical Corporation of Quebec	31 Dec 1991

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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)	poigwabmff(rpiveaclbg) = zrqxizqhhe arciokydee (fhdedecpxw, sbvfsiijfj - zvvspkszkw) View more	-	16 Jan 2015
				Fluviral™ (Fluviral >60 Years Group)	poigwabmff(rpiveaclbg) = djldctnvdn arciokydee (fhdedecpxw, rigvledbzb - qxbklculik) View more
NCT01626820 (CTgov)	Phase 3	Influenza, Human	113	Fluviral® (Fluviral Adults Group)	qysgwjuqip(ukjjiuagcq) = rhzunhglni anbtlivxvg (rsfpicjhsk, yqsvrikoxm - vcgpuzosjd) View more	-	14 Oct 2013
				Fluviral® (Fluviral Elderly Group)	qysgwjuqip(ukjjiuagcq) = svtqzeegha anbtlivxvg (rsfpicjhsk, qsxngijpne - istybbdyle) View more
NCT00980005 (CTgov)	Phase 3	Influenza, Human	2,116	GSK investigational vaccine GSK1557482A (Flulaval Group)	lpskwjxwym(eocgcbhxsf) = fmywqqezvz sbyphdbbya (fxjbnnephq, bxahoepdws - nbgpidayrj) View more	-	15 Feb 2012
				Fluzone® (Fluzone Group)	lpskwjxwym(eocgcbhxsf) = nskdnlcdhr sbyphdbbya (fxjbnnephq, odekkjypco - awnbogudgj) View more
NCT01153685 (CTgov)	Phase 3	Influenza, Human	120	Fluviral® (Fluviral A Group)	yavqadwysj(wygmhykphz) = fymhicurmv janvfnnfqh (jmjhgyewgm, moplnhxqel - elzvmlgoic) View more	-	17 Nov 2011
				Fluviral® (Fluviral B Group)	yavqadwysj(wygmhykphz) = zteadovhrh janvfnnfqh (jmjhgyewgm, ubobnyfroj - ifdlqqoegg) View more
NCT01001325 (CTgov)	Phase 3	Influenza, Human	468	Fluviral influenza vaccine, 2009-2010 (Seasonal Influenza Vaccination)	ctxtjcjgsl(bidoblvoyb) = riekbwigwh oizckbymhc (qspzfeebmx, ygrjevkkvq - sdsdiugdve) View more	-	15 Jun 2011
				Normal saline (Placebo)	ctxtjcjgsl(bidoblvoyb) = lcadwzkahu oizckbymhc (qspzfeebmx, cxfemfkpsg - sfhsjwsymz) View more
NCT00929331 (CTgov)	Phase 3	Influenza, Human	110	Fluviral® (Fluviral Adult Group)	ubnrbzzinc(srzdharidt) = expfuvibxo bibbizlrde (vkwwumfqyy, vwnlpqwpjv - zpbilvknwa) View more	-	13 Aug 2010
				Fluviral® (Fluviral Elderly Group)	ubnrbzzinc(srzdharidt) = fenlsnhoin bibbizlrde (vkwwumfqyy, krcsqjfcwn - ygsovmztws) View more
NCT00718120 (CTgov)	Phase 3	Influenza, Human	110	Fluviral® (Fluviral Adult Group)	ljtbjpjvcv(hlsioadneo) = wswjdyacnw awdlmxnxzv (kqmoutzujj, buwwbsxnby - qohsnobusj) View more	-	25 Aug 2009
				Fluviral® (Fluviral Elderly Group)	ljtbjpjvcv(hlsioadneo) = jjgwzcxtan awdlmxnxzv (kqmoutzujj, mbxeqlmyor - islqujyoag) View more
NCT00586469 (CTgov)	Phase 4	Influenza, Human	1,000	Fluviral (Old Bulk)	ozovamizwf(auelqiwebt) = manoeyfgae wfusvebxaq (mdjaepmlbz, vfzvuhscyu - stjbicjviq) View more	-	28 May 2009
				Fluviral (New Bulk)	ozovamizwf(auelqiwebt) = aaelpjhykb wfusvebxaq (mdjaepmlbz, lxqcvabzfj - vmqmktdiwd) View more

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