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-

Action

stimulants

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

Russia (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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21

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

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.

02 Dec 2018·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Prospective randomized open-label comparative study of immunogenicity after subunit and polymeric subunit influenza vaccines administration among mothers and infants

Q3 · MEDICINE

Article

Author: Akhmatova, Nelli Kimovna ; Kuselman, Alexei Isaevich ; Cherdantsev, Alexander Petrovich ; Kostinova, Aristitsa Mikhailovna ; Demina, Evgeniia Olegovna ; Deryabina, Elena Viktorovna ; Kostinov, Anton Mikhailovich ; Kostinov, Mikhail Petrovich

Pregnant women are risk group for influenza infection. Results of new subunit vaccines application have not been studied enough. Prospective, randomized, open-label comparative study of subunit (Agrippal) and polymeric subunit (Grippol plus) vaccines. 42 pairs of mothers-infants were participated in the study. Protective antibodies (≥ 1:40) to different influenza strains were registered on day 1 after the birth on the same level as 53% of cases in pairs mothers-infants after immune adjuvant polymeric subunit and subunit vaccines administration. There were the same level of protective antibodies (AB) among mothers after 3 month, but transplacental antibodies decreased among infants and registered in the 13-22% cases of Grippol plus group and 31-43% cases in Agrippal S1 group. AB titre to influenza virus A/H1N1/pdm09 and A/H3N2/in pairs mothers-infants were the same in both groups in first days after birth, but AB levels to B strain were lower among infants without regard to vaccine. There is no difference in AB titres among infants of both groups at 3 month of age, but their levels were twice lower versus initial data. An immune adjuvant polymeric subunit as well as subunit vaccines application in pregnant women forms protective AB in pairs mothers-infants.

01 Sep 2016·Zhurnal mikrobiologii, epidemiologii i immunobiologii

[EFFECT OF INFLUENZA VACCINES ON SUBPOPULATIONS OF BLOOD DENDRITIC CELLS].

Article

Author: Semochkin, L A ; Skhodova, S A ; Kostinov, M P ; Chromova, E A ; Khomenkov, V G ; Akhmatova, N K ; Akhmatova, E A

AIMStudy the effect of Vaxigrip split, Influvac subunit and Grippol plus immune-adjuvanted vaccines on the content of myeloid (mDC) and plasmacytoid (pDC) dendritic cells (DC) in blood of vaccinated healthy women. Materials andmethods. Blood of 30 healthy women aged 18-50 years was studied at days 7 and 30 after the vaccination. pDC (CD14+CD16-/CD85k(ILT3)-PE/ CD123-PC5) and mDC (CD14+CD-16-/CD85k(ILT3)-PE/CD33 -PC5) immune phenotyping was carried out using mAbs (Beckman Coulter, France) and flow cytometer Cytomix FC-500 (Beckman Coulter, USA).RESULTSUse of unadjuvanted vaccines Vaxigrip and Influvac resulted in an increase of the numbers of mDC and pDC (p<0.05) in blood of the vaccinated only at day 7 of the observation. Grippol resulted in a more significant (2.2 - 3.6 times, p<0.05) increase of DC subpopulations (compared with unadjuvanted vaccines) at both day 7 and a month after the vaccination.CONCLUSIONInfluenza vaccination activated innate effectors - the first component on the way of infection penetration - dendritic cells of both myeloid and lymphoid origin. Wherein, a more pronounced and prolonged effect of such activation is observed when immune-adjuvanted vaccine is used compared with subunit and split vaccines.

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	Russia	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	Russia	NPO Petrovax Pharm Ltd.	21 Sep 2022
Influenza A virus infection	Phase 3	Russia	NPO Petrovax Pharm Ltd.	21 Sep 2022
Influenza B virus infection	Phase 3	Russia	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)	vklswixsbn(rhtssojxhe) = eywlfawjyx kpgsvlojal (ewpnsdbgqs, voozuyidlm - joztorxdzx) View more	-	04 Nov 2024
				Grippol® Plus, trivalent (Yamagata lineage) (Grippol® Plus, Trivalent (Yamagata Lineage))	vklswixsbn(rhtssojxhe) = pghnpfzqua kpgsvlojal (ewpnsdbgqs, tsqjejmscb - xawmxbcjsm) View more