A5009044789- Transgenic Plants and Applications
- Viral gastroenteritis research and epidemiology
- Influenza Virus Research Studies
- SARS-CoV-2 and COVID-19 Research
- Plant Virus Research Studies
- Vaccine Coverage and Hesitancy
- Hepatitis B Virus Studies
- CRISPR and Genetic Engineering
- Plant tissue culture and regeneration
- Respiratory viral infections research
- Viral Infections and Outbreaks Research
- Animal Disease Management and Epidemiology
- Immunotherapy and Immune Responses
- Immune Cell Function and Interaction
- Viral Infectious Diseases and Gene Expression in Insects
- Vector-Borne Animal Diseases
- Animal Virus Infections Studies
- COVID-19 Impact on Reproduction
- Immune cells in cancer
- Viral Infections and Vectors
- Advancements in Transdermal Drug Delivery
- Monoclonal and Polyclonal Antibodies Research
- Seed and Plant Biochemistry
- Spectroscopy Techniques in Biomedical and Chemical Research
- COVID-19 Clinical Research Studies
PharmaJet (United States)
2024
Medicago (Canada)
2014-2023
McGill University
2023
McGill University Health Centre
2015
Hertfordshire Community NHS Trust
2008
The recent swine H1N1 influenza outbreak demonstrated that egg-based vaccine manufacturing has an Achille's heel: its inability to provide a large number of doses quickly. Using novel platform based on transient expression surface glycoproteins in Nicotiana benthamiana, we have recently candidate Virus-Like Particle (VLP) can be generated within 3 weeks release sequence information. Herein report alum-adjuvanted plant-made VLPs containing the hemagglutinin (HA) protein H5N1...
Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes...
Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of original strain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) combined with an adjuvant (Adjuvant System 03 [AS03]) to form candidate vaccine.In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (≥18 years age) a 1:1 ratio receive two intramuscular injections CoVLP+AS03 vaccine or placebo 21 days apart. The...
Summary A strain‐specific vaccine represents the best possible response to threat of an influenza pandemic. Rapid delivery such a world's population before peak first infection wave seems be unattainable goal with current manufacturing capacity. Plant‐based transient expression is one few production systems that can meet anticipated surge requirement. To assess capability plant agroinfiltration produce vaccine, we expressed haemagglutinin (HA) from strains A/Indonesia/5/05 (H5N1) and A/New...
Recent issues regarding efficacy of influenza vaccines have re-emphasized the need new approaches to face this major public health issue. In a phase 1-2 clinical trial, healthy adults received one intramuscular dose seasonal plant-based quadrivalent virus-like particle (QVLP) vaccine or placebo. The hemagglutination inhibition (HI) titers met all European licensure criteria for type A strains at 3μg/strain and four higher dosages 21days after immunization. High HI were maintained most...
Background New influenza vaccines eliciting more effective protection are needed, particularly for the elderly who paid a large and disproportional toll of hospitalization dead during seasonal epidemics. Low (≤15 μg/strain) doses new plant-derived virus-like-particle (VLP) vaccine candidate have been shown to induce humoral cellular responses against both homologous heterologous strains in healthy adults 18–64 years age. The two clinical trials reported here addressed safety immunogenicity...
Abstract Although antivirals are important tools to control severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, effective vaccines essential the current disease 2019 (COVID-19) pandemic. Plant-derived virus-like particle (VLP) vaccine candidates have previously demonstrated immunogenicity and efficacy against influenza. Here, we report protection induced in rhesus macaques by intramuscular injections of a VLP bearing SARS-CoV-2 spike protein (CoVLP) candidate formulated...
The hemagglutinination inhibition (HI) response remains the gold standard used for licensure of influenza vaccines. However, cell-mediated immunity (CMI) deserves more attention, especially when evaluating H5N1 vaccines that tend to induce poor HI response. In this study, we measured humoral and CMI (flow cytometry) during a Phase II dose-ranging clinical trial (NCT01991561). Subjects received two intramuscular doses, 21 days apart, plant-derived virus-like particles (VLP) presenting...
Longer Abstract Background The stabilized prefusion form of the SARS-CoV-2 spike protein is produced by transient expression in Nicotiana benthamiana . trimeric glycoproteins are displayed at surface self-assembling Virus-Like-Particles that mimic shape and size virus. candidate vaccine (CoVLP) administered alone or with AS03 CpG1018 adjuvants was evaluated a Phase 1 trial healthy adults. ( ClinicalTrials.gov number NCT04450004 ) Methods study randomized, partially-blinded, prime-boost 21...
The rapid spread of SARS-CoV-2 continues to impact humanity on a global scale with rising total morbidity and mortality. Despite the development several effective vaccines, new products are needed supply ongoing demand fight variants. We report herein pre-specified interim analysis phase 2 portion Phase 2/3, randomized, placebo-controlled trial coronavirus virus-like particle (CoVLP) vaccine candidate, produced in plants that displays spike glycoprotein, adjuvanted AS03 (NCT04636697). A 753...
Plant-made virus-like particle (VLP) vaccines that display wild-type influenza hemagglutinin (HA) are rapidly advancing through clinical trials. Produced by transient transfection of Nicotiana benthamiana, these novel unusually immunogenic, eliciting both humoral and cellular responses. Here, we directly visualized VLPs bearing either HA trimers derived from strains A/California/7/2009 or A/Indonesia/5/05 using cryo-electron microscopy determined the 3D organization tomography. More than...
We present an adjuvant for intradermal use that works in humans, enabling self-administration case of a flu pandemic.
A growing body of evidence supports the importance T cell responses to protect against severe influenza, promote viral clearance, and ensure long-term immunity. Plant-derived virus-like particle (VLP) vaccines bearing influenza hemagglutinin (HA) have been shown elicit strong humoral CD4+ in both pre-clinical clinical studies. To better understand immunogenicity these vaccines, we tracked intracellular fate a model HA (A/California/07/2009 H1N1) human monocyte-derived macrophages (MDMs)...
Abstract The rapid spread of SARS-CoV-2 continues to impact humanity on a global scale with rising total morbidity and mortality. Despite the development several effective vaccines, new products are needed supply ongoing demand needs specific populations. We report herein pre-specified interim analysis phase 2 portion an Phase 2/3, randomized, placebo-controlled trial coronavirus virus-like particle (CoVLP) vaccine candidate produced in plants that displays spike glycoprotein adjuvanted AS03...
Summary Influenza virus‐like particles ( VLP s) are noninfectious resembling the influenza virus representing a promising vaccine alternative to inactivated virions as antigens. Medicago inc. has developed plant‐based manufacturing platform allowing large‐scale production of GMP ‐grade s. In this article, we report on biochemical compositions these candidate vaccines, more particularly characterization N‐ glycan profiles viral haemagglutinins H1 and H5 proteins well tobacco‐derived lipid...
Abstract Hantaan virus (HTNV) and Puumala (PUUV) are pathogenic zoonoses found in Asia Europe, respectively. We conducted a randomized Phase 1 clinical trial of individual HTNV PUUV DNA vaccines targeting the envelope glycoproteins (GnGc), as well combined HTNV/PUUV vaccine delivered at varying doses using PharmaJet Stratis® needle-free injection system (NCT02776761). Cohort 2 consisted mg/vaccination or plasmid, 3 1:1 mixture vaccines. Vaccinations were administered on Days 0, 28, 56, 168....
Abstract Background Administered intramuscularly (IM), plant-derived, virus-like-particle (VLP) vaccines based on the influenza hemagglutinin (HA) protein elicit both humoral and cellular responses that can protect aged mice from lethal challenge. Unlike split virus vaccines, VLPs be administered by different routes including intranasally (IN). We evaluated novel vaccine strategies such as prime-pull (IM boosted IN) multi-modality vaccination IN given simultaneously). wished to determine if...