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

+ [3]

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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108

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

31 Dec 2025·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of a bivalent norovirus vaccine candidate in infants from 6 weeks to 5 months of age: A phase 2, randomized, double-blind trial

Article

Author: López, Pío ; Mendelman, Paul M ; Baehner, Frank ; Borkowski, Astrid ; Sáez-Llorens, Xavier ; Sherwood, Jim ; deAntonio, Rodrigo ; Masuda, Taisei ; López-Medina, Eduardo

As infants suffer significant morbidity and mortality due to norovirus-related acute gastroenteritis (AGE), we assessed four formulations of the bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in Panamanian and Colombian infants. 360 infants aged 6 weeks to 5 months were randomly allocated to 8 groups to receive three doses of HIL-214 or two doses of HIL-214 and one dose of placebo (Days 1, 56 and 112), where HIL-214 doses contained 15/15, 15/50, 50/50 or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)₃. Solicited injection-site and systemic adverse events (AE) were collected within 7 days after each dose, unsolicited AEs were collected within 28 days after each, and serious AEs throughout the study. Pan-Ig and histoblood group antigen-blocking antibodies (HBGA) were measured on Days 1, 56, 84, and 140. All formulations were well-tolerated causing mainly mild-to-moderate transient solicited AEs, most frequently local pain and irritability/fussiness, but no vaccine-related serious AEs. Two doses of each formulation induced high titers of high avidity Pan-Ig and also HBGA antibodies; a third dose increased titers against both antigens and the avidity of Pan-Ig antibodies against GII.4c but not against GI.1. Two and three doses of HIL-214 were well-tolerated and induced potent immune responses at 4-6 months of age supporting further clinical assessment to protect against norovirus-related AGE.

01 Jan 2025·International Journal of Biological Macromolecules

Investigating the stability of chimeric murine polyomavirus VP1 Capsomeres via molecular dynamics simulations and experimental analysis

Article

Author: Zhang, Songping ; Luo, Hong ; Ma, Yanyan ; Gerstweiler, Lukas ; Gu, Yanhao ; Su, Zhiguo

The development of modular virus-like particle (VLP) vaccine platforms with genetically inserted antigens in viral structural proteins shows great promise for advancing vaccine technology. However, the instability of many constructs leads to trial-and-error approaches, and the challenge of predicting stability based solely on amino acid sequences remains unresolved, yet highly appealing. This study evaluates the stability of wild-type murine polyomavirus (MPV) VP1 capsomeres and three engineered chimeric variants using molecular dynamics (MD) simulations and laboratory experiments. MD simulations, based on AlphaFold2 predictions and up-to-date all-atom force fields, accurately predicted the thermal stability and hydrophobicity of VP1-based capsomeres. Thermodynamic analysis revealed that binding energies from simulations reliably indicate thermal stability. Experiments and simulation results showed that inserts influence the stability of capsomeres differently, with larger insertions generally having a greater impact on the structures of capsomeres. This leads to increased intra-subunit distances and a higher proportion of flexible regions in the capsomere chassis. Capsomeres with less compact structures were found to have lower thermal stability. Specifically, the thermal transitional temperature (T_m) of the wild-type capsomeres was 46.9 °C, while the T_m values of the three chimeric derivatives were 42.0 °C, 38.8 °C, and 37.7 °C, reflecting a correlation between decreased thermal stability and reduced structural compactness. This research presents a robust approach for predicting the stability of novel VLP constructs based on amino acid sequences, potentially enhancing vaccine design by reducing failures, and suggests a shift towards minimal epitope insertions for improved stability.

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

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).

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	Phase 1	-	Medicago, Inc.	-
Influenza, Human	Phase 1	-	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)	puyqulajfh(vissxfvylk) = mljkikjadm iinhzixvfg (qpqdxqccwy, azmzovvdzs - jfoqdsndzl) View more	-	14 Aug 2023
				Placebo (Placebo)	puyqulajfh(vissxfvylk) = ilrsrkxbgu iinhzixvfg (qpqdxqccwy, rddgiemmxm - vzgagjcscr) View more
NCT03321968 (CTgov)	Phase 3	Influenza, Human	1,202	Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 1)	keirvcidrs(zdxfehrrvh) = zfbdpnrzqm ocaldycgii (yajidsmjfs, cqjiwpzsac - dmgqkkqqnp) View more	-	04 Aug 2023
				Quadrivalent VLP Influenza Vaccine (Quadrivalent VLP Influenza Vaccine - Lot 2)	keirvcidrs(zdxfehrrvh) = okooxzbnyv ocaldycgii (yajidsmjfs, jwxoyichvo - ymxjadnitk) View more
NCT04622592 (CTgov)	Phase 1/2	Influenza, Human	209	Instramuscular vaccine (QVLP15+Full AS03)	aeewggwisf(izogmzwaop) = clnsporazn hjyghsegqd (kcujqqutwh, kbfbsqwfru - tyzlqiyylf) View more	-	21 Jul 2023
				Instramuscular vaccine (QVLP15+Half AS03)	aeewggwisf(izogmzwaop) = lwesgzihho hjyghsegqd (kcujqqutwh, evqbbirbdj - bdqhuqdhxj) View more