V590 News - LARVOL Sigma

|||||||||| V590 / Merck (MSD), IAVI
Preclinical, Journal: Purification processes of live virus vaccine candidates expressed in adherent Vero cell lines via multimodal chromatography in flowthrough mode. (Pubmed Central) - May 20, 2023
For both V590 and Measles processing, the employed resins cleared a key HCP, fibronectin, which could foul the UF/DF unit operation, and thusly enabling it to further reduce HCPs and to formulate the final LVV products. This integrated purification process utilizes the complementary action of the two unit operations and its applicability across LVVs supports its consideration for their processing.

|||||||||| V590 / Merck (MSD), IAVI
Journal: Understanding the Spike Protein in COVID-19 Vaccine in Recombinant Vesicular Stomatitis Virus (rVSV) Using Automated Capillary Western Blots. (Pubmed Central) - Jan 24, 2023
Finally, V590 stressed stability studies suggested that time and temperature contributed to the instability of S protein demonstrated by cleavage into its subunits, S1 and S2, and aggregation into S multimer. Both of which could potentially have a deleterious effect on the vaccine immunogenicity.

|||||||||| V590 / Merck (MSD), IAVI
Journal: Development and scale-up of rVSV-SARS-CoV-2 vaccine process using single use bioreactor. (Pubmed Central) - Jan 24, 2023
Among many efforts to urgently develop a vaccine against this disease, we developed an industrial-scale closed, single use manufacturing process for V590, a vaccine candidate for SARS-CoV-2...The optimal production condition was successfully scaled up to a 2000 L Single Use Bioreactor (SUB), producing a maximum virus titer of ∼1.0e+7 plaque forming units (PFU)/mL. Further process intensification and simplification, including growing Vero cells at 2 gs per liter (g/L) of Cytodex-1 Gamma microcarriers and eliminating the media exchange (MX) step prior to infection helped to increase virus productivity by ∼2-fold.

|||||||||| V590 / Merck (MSD), IAVI
P1 data, Journal: Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial. (Pubmed Central) - Aug 18, 2022
P1
V590 was generally well-tolerated. However, Day 28 anti-SARS-Cov-2 spike-specific antibody responses in seronegative participants following a single intramuscular administration of V590 were not sufficient to warrant continued development.

|||||||||| V590 / Institute for Systems Biology, Merck (MSD), IAVI
[VIRTUAL] An Innovative Partnership Model to Accelerate Development of V590 – A Recombinant VSV SARS-CoV-2 Vaccine Candidate () - Apr 4, 2021 - Abstract #PEGS2021PEGS_513;
V590 has generated strong preclinical data and clinical studies are ongoing. The organizations are working in an innovative partnership to accelerate the vaccine’s development and make it accessible globally, if approved.

||||||||||  V590 / Merck (MSD), IAVI
Trial termination:  Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) -  Mar 3, 2021
P1, N=232, Terminated,  Sponsor: Merck Sharp & Dohme Corp.
The organizations are working in an innovative partnership to accelerate the vaccine’s development and make it accessible globally, if approved. Active, not recruiting --> Terminated; The study was terminated based on an interim assessment of immunogenicity.

||||||||||  V590 / Merck (MSD), IAVI
Trial completion date, Trial primary completion date:  Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) -  Feb 4, 2021
P1, N=252, Active, not recruiting,  Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Terminated; The study was terminated based on an interim assessment of immunogenicity. Trial completion date: Jan 2022 --> Feb 2021 | Trial primary completion date: Jan 2022 --> Feb 2021

||||||||||  V590 / Merck (MSD), IAVI
Enrollment closed:  Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) -  Feb 1, 2021
P1, N=252, Active, not recruiting,  Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jan 2022 --> Feb 2021 | Trial primary completion date: Jan 2022 --> Feb 2021 Recruiting --> Active, not recruiting

||||||||||  V590 / Merck (MSD), IAVI
Enrollment open:  Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) -  Nov 5, 2020
P1, N=252, Recruiting,  Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  V590 / Merck (MSD), IAVI
New P1 trial:  Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) -  Sep 29, 2020
P1, N=252, Not yet recruiting,  Sponsor: Merck Sharp & Dohme Corp.



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