Delving into the Latest Updates on Seasonal quadrivalent influenza vaccine(Medicago, Inc.) with Synapse

Overview

Basic Info

Drug Type

Virus-like particle vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Influenza virus vaccine quadrivalent, Quadrivalent seasonal influenza VLP vaccine, Seasonal influenza vaccine quadrivalent

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Influenza, Human

Originator Organization

Medicago, Inc.

Active Organization-

Inactive Organization

Medicago, Inc.

Drug Highest PhaseDiscontinuedNDA/BLA

First Approval Date-

Regulation-

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This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains.
In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development.
Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).

Start Date02 Nov 2020

Sponsor / Collaborator

Medicago, Inc.

NCT03739112 / CompletedPhase 3

A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

Start Date18 Sep 2018

Sponsor / Collaborator

Medicago, Inc.

NCT03321968 / CompletedPhase 3

A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

Start Date29 Sep 2017

Sponsor / Collaborator

Medicago, Inc.

100 Clinical Results associated with Seasonal quadrivalent influenza vaccine(Medicago, Inc.)

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100 Translational Medicine associated with Seasonal quadrivalent influenza vaccine(Medicago, Inc.)

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100 Patents (Medical) associated with Seasonal quadrivalent influenza vaccine(Medicago, Inc.)

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104

Literatures (Medical) associated with Seasonal quadrivalent influenza vaccine(Medicago, Inc.)

31 Dec 2024·Human Vaccines & Immunotherapeutics

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Article

Author: Miller, Jacqueline ; Naficy, Abdi ; Seifert, Harry ; Mwakingwe-Omari, Agnes ; Hastie, Andrew ; Leav, Brett ; Anteyi, Kate ; Kuxhausen, Adrienne

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

15 Oct 2024·Clinical Infectious Diseases

Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial

Article

Author: Dezutter, Nancy ; Rebollo-Rodrigo, Maria Henar ; Meyer, Nadia ; Jayadev, Amulya ; Kotb, Shady ; Amare Hailemariam, Hiwot ; Germain, Sophie ; Rämet, Mika ; Labrador, Jorge ; Davies, Sam ; David, Marie-Pierre ; Nicolas, Jean-François ; Sanz-Muñoz, Iván ; Moríñigo, Helena Moza ; Clark, Rebecca ; Loubet, Paul ; Vera, Mercè Pérez ; Natalini Martínez, Silvina

AbstractBackgroundWe evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.MethodsThis phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed.ResultsOverall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06–1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups.ConclusionsAdjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine.Clinical Trials RegistrationNCT05568797

06 Aug 2024·Microbiology Spectrum

H3N2 canine influenza virus-like particle vaccine with great protection in beagle dogs

Article

Author: Huang, Shixin ; Li, Xin ; Yang, Xian-Cao ; Yang, De-Quan ; Wang, Jian ; Ge, Fei-Fei ; Shen, Li-Pin ; Shen, Hai-Xiao

ABSTRACTIn 2016, a distinct branch of H3N2 canine influenza virus (CIV) emerged, which has mutations related to mammalian adaptation and has replaced previously prevalent strains. This branch poses a risk of zoonotic infection. To prevent and control H3N2 CIV, an H3N2 virus-like particle (VLP) vaccine based on the insect cell baculovirus expression system has been developed in the study. The H3N2 VLP vaccine induced high titers of hemagglutination inhibition (HI) antibodies in nasal and muscular immunized beagle dogs. Meanwhile, the VLP vaccine provided effective protection against homologous virus challenge comparable to inactivated H3N2 canine influenza virus. In addition, the intranasal H3N2 VLP vaccine induced significantly higher Th1, Th2, and Th17 immune responses, respectively (p,0.05). Importantly, intramuscular injection of VLP and inactivated H3N2 virus has complete protective effects against homologous H3N2 virus attacks. Nasal immunization with H3N2 VLP can partially protect beagles from H3N2 influenza.IMPORTANCEA new antigenically and genetically distinct canine influenza virus (CIV) H3N2 clade possessing mutations associated with mammalian adaptation emerged in 2016 and substituted previously circulating strains. This clade poses a risk for zoonotic infection. In our study, intramuscular injection of the H3N2 virus-like particle (VLP) vaccine and inactivated H3N2 CIV confer completely sterilizing protection against homologous H3N2 canine influenza virus challenge. Our results provide further support for the possibility of developing VLP vaccines that can reliably induce immunity in animal species.

100 Deals associated with Seasonal quadrivalent influenza vaccine(Medicago, Inc.)

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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	NDA/BLA	-	Medicago, Inc.	-
Influenza, Human	NDA/BLA	-	Medicago, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03301051 (CTgov)	Phase 3	RNA Virus Infections \| Respiratory Diseases \| Influenza, Human \| Respiratory Tract Infections \| Virus Diseases	10,160	Quadrivalent VLP Vaccine (Quadrivalent VLP Vaccine)	uotvixosaq(grjeovzsxy) = ivigjufmhh xlhwobiwck (mwckmjdiyt, axqlrnuysu - crrhlyhsbo) View more	-	14 Aug 2023
				Placebo (Placebo)	uotvixosaq(grjeovzsxy) = eildqqptno xlhwobiwck (mwckmjdiyt, cuhhruyomm - uyakclkssu) View more
NCT03321968 (CTgov)	Phase 3	Influenza, Human	1,202	Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 1)	bdjzexxrpd(nvemguwrdc) = qwqmfbebvw zkxxwzeujx (vdcxpjvpwd, bqjrsfocsp - sorhhxyikt) View more	-	04 Aug 2023
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	bdjzexxrpd(nvemguwrdc) = ejzskiubeb zkxxwzeujx (vdcxpjvpwd, gniegyjoll - zpktnuejjs) View more
NCT04622592 (CTgov)	Phase 1/2	Influenza, Human	209	Instramuscular vaccine (QVLP15+Full AS03)	weftcqhxnl(yqsnwkxpxg) = dwgwddrxem gstkygahuw (dewixzldlz, ybcietfgoa - pdiubpjcat) View more	-	21 Jul 2023
				Instramuscular vaccine (QVLP15+Half AS03)	weftcqhxnl(yqsnwkxpxg) = srnsufphdg gstkygahuw (dewixzldlz, xunrasseqw - lopnvzxuhk) View more