Delving into the Latest Updates on Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Grippol, Grippol®Quadrivalent

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, HumanAcute respiratory infectionsInfluenza A virus infection+ [1]

Inactive Indication-

Originator Organization

NPO Petrovax Pharm Ltd.

Active Organization

NPO Petrovax Pharm Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

RU (01 Sep 2018),

Influenza, Human

Regulation-

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The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".

Start Date21 Sep 2022

Sponsor / Collaborator

NPO Petrovax Pharm Ltd.

NCT05471531

/ CompletedPhase 4

Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above

This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.

Start Date13 Nov 2021

Sponsor / Collaborator

Sinovac Biotech Co. Ltd.

NCT03849560

/ CompletedPhase 2/3

A Multicenter, Double-Blind, Randomized, Parallel Group Study of Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Influenza Vaccine Grippol Quadri and Trivalent Influenza Vaccine Grippol Plus in Volunteers.

The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 60 years old.

Start Date01 Nov 2016

Sponsor / Collaborator

NPO Petrovax Pharm Ltd.

100 Clinical Results associated with Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)

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100 Translational Medicine associated with Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)

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100 Patents (Medical) associated with Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)

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27

Literatures (Medical) associated with Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)

01 Jul 2023·Open forum infectious diseases

Relative Effectiveness of the Cell-Based Quadrivalent Influenza Vaccine in Preventing Cardiorespiratory Hospitalizations in Adults Aged 18-64 Years During the 2019-2020 US Influenza Season.

Article

Author: Lopez-Gonzalez, Lorena ; Imran, Mahrukh ; Dean, Alex ; Haag, Mendel ; Ortiz, Justin R ; Bonafede, Machaon ; Puig-Barbera, Juan

BackgroundThe mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) has advantages over egg-based quadrivalent inactivated influenza vaccine (IIV4e), as production using cell-derived candidate viruses eliminates the opportunity for egg adaptation. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus IIV4e in preventing cardiorespiratory hospitalizations during the 2019-2020 US influenza season.MethodsWe conducted a retrospective cohort study using electronic medical records linked to claims data of US individuals aged 18-64 years. We assessed rVE against cardiorespiratory hospitalizations and against subcategories of this outcome, including influenza, pneumonia, myocardial infarction and ischemic stroke, and respiratory hospitalizations. We used a doubly robust inverse probability of treatment weighting and logistic regression model to obtain odds ratios (ORs; odds of outcome among IIV4c recipients/odds of outcome among IIV4e recipients) adjusted for age, sex, race, ethnicity, geographic region, vaccination week, health status, frailty, and healthcare resource utilization. rVE was calculated as 100(1 - OR_adjusted).ResultsIn total, 1 491 097 individuals (25.2%) received IIV4c, and 4 414 758 (74.8%) received IIV4e. IIV4c was associated with lower odds of cardiorespiratory (rVE, 2.5% [95% confidence interval, 0.9%-4.1%]), respiratory (3.7% [1.5%-5.8%]), and influenza (9.3% [0.4%-17.3%]) hospitalizations among adults 18-64 years of age. No difference was observed for the other outcomes.ConclusionsThis real-world study conducted for the 2019-2020 season demonstrated that vaccination with IIV4c was associated with fewer cardiorespiratory, respiratory, and influenza hospitalizations compared with IIV4e.

01 Jan 2022·The Lancet Infectious DiseasesQ1 · MEDICINE

Quadrivalent adjuvanted haemagglutinin nanoparticle influenza vaccine: a step towards better protection of older adults from the constantly mutating H3N2 influenza viruses

Q1 · MEDICINE

Article

Author: Matyushenko, Victoria ; Isakova-Sivak, Irina

The H3N2 influenza subtype has been highly researched due to its rapid mutational variability, which allows it to escape a preexisting immune response, meaning that the effectiveness of the H3N2 vaccine component has been extremely low over the past few seasons, since the 2014-15 season.It is therefore not surprising that in seasons when the H3N2 virus predominates, many countries have markedly higher mortality rates than in other seasons, especially in older people, owing to their reduced immune functions.In attempts to overcome the issue of immunosenescence in older adults, new enhanced influenza vaccines are being developed, such as high-dose vaccines or vaccines formulated with potent adjuvants.

01 Sep 2020·VaccineQ3 · MEDICINE

Low-dose influenza vaccine Grippol Quadrivalent with adjuvant Polyoxidonium induces a T helper-2 mediated humoral immune response and increases NK cell activity

Q3 · MEDICINE

Article

Author: Matveichev, Alexei ; Babaykina, Olga ; Voronina, Elena ; Mironov, Andrei ; Talayev, Vladimir ; Svetlova, Maria ; Zaichenko, Irina

The influenza vaccine Grippol® Quadrivalent (GQ) is a new vaccine, containing the adjuvant Polyoxidonium® and recombinant hemagglutinins from 4 strains of the influenza virus in amount of 5-6 μg of each hemagglutinin per human dose. These doses of antigens are about 3 times less than the standard dose recommended by WHO. We sought to characterize the immune response to the GQ vaccine and to determine the contribution of the adjuvant in this response. BALB/c mice were vaccinated with GQ or with adjuvant-free antigen mixtures (AGs). Then, the antibody response, the number of memory T cells in the spleen, and the functional properties of splenocytes were determined. The vaccine GQ has been shown to induce antibodies to all 4 influenza hemagglutinins. The vaccination with GQ caused a strong increase in the AG-induced proliferation and production of Th2 cytokines ex vivo. These effects were equal to effect achieved by standard dose of antigens. Vaccination also caused the accumulation of CD4⁺ large lymphocytes with the phenotype of central and effector memory T cells in the spleen. The GQ vaccine enhanced the cytolytic activity of natural killer (NK) cells, whereas the adjuvant-free mixture of AGs in lowered and standard doses did not affect NK activity. We did not find a noticeable response of Th1 and CD8⁺ T cells to vaccination. In vitro, the GQ vaccine stimulated the maturation of human monocyte-derived dendritic cells (DCs) enhancing the expression of HLA-DR, CD80, CD83, CD86 and ICOSL molecules. Polyoxidonium without AGs also induced expression of ICOSL, which plays an important role in T-dependent humoral immune response. In summary, the low-dose influenza vaccine GQ with Polyoxidonium adjuvant is immunogenic, induces a Th2-polarized T-cell response and CD4⁺ memory T cells maturation, activates the production of antibodies to influenza hemagglutinins, and increases the activity of NK cells.

100 Deals associated with Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	RU	NPO Petrovax Pharm Ltd.	01 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute respiratory infections	Phase 3	RU	NPO Petrovax Pharm Ltd.	21 Sep 2022
Influenza A virus infection	Phase 3	RU	NPO Petrovax Pharm Ltd.	21 Sep 2022
Influenza B virus infection	Phase 3	RU	NPO Petrovax Pharm Ltd.	21 Sep 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03849560 (CTgov)	Phase 2/3	Influenza, Human	612	Grippol® Quadri (Grippol® Quadri)	zheuzkmsvv(vbsnyjklky) = ixnritxhiw tzgoouywvl (vqbjdbpguv, euswyiyjwf - qufcxtrpjq) View more	-	04 Nov 2024
				Grippol® Plus, trivalent (Yamagata lineage) (Grippol® Plus, Trivalent (Yamagata Lineage))	zheuzkmsvv(vbsnyjklky) = zpuerwwwtd tzgoouywvl (vqbjdbpguv, grvckftmws - ssivjbrncu) View more