V590 / Merck (MSD), IAVI - LARVOL DELTA

Purification processes of live virus vaccine candidates expressed in adherent Vero cell lines via multimodal chromatography in flowthrough mode. (PubMed, Biotechnol Bioeng) - "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."

Journal • Preclinical • Infectious Disease

Understanding the Spike Protein in COVID-19 Vaccine in Recombinant Vesicular Stomatitis Virus (rVSV) Using Automated Capillary Western Blots. (PubMed, ACS Omega) - "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."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development and scale-up of rVSV-SARS-CoV-2 vaccine process using single use bioreactor. (PubMed, Biotechnol Rep (Amst)) - "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."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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, EBioMedicine) - 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."

Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates (Businesswire) - P1, N=252; NCT04569786; P1/2, N=260; NCT04498247; Sponsor: Merck Sharp & Dohme Corp.; "Merck...announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus...on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior...MK-7110 (formerly CD24Fc)...Full results from this study are expected in the first quarter of 2021....Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings....The company anticipates initial efficacy data in the first quarter of 2021, which Merck plans to share publicly if clinically meaningful."

Discontinued • P1 data • P2/3 data • P3 data • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] An Innovative Partnership Model to Accelerate Development of V590 – A Recombinant VSV SARS-CoV-2 Vaccine Candidate (PEGS 2021) - "Merck and IAVI are collaborating to develop an investigational vaccine against SARS-CoV-2 which combines the vaccine R&D capabilities of both organizations and uses the same rVSV platform as Ervebo, the first rVSV-based licensed vaccine for prevention of Ebola Zaire. 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."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) - P1; N=232; Terminated; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Terminated; The study was terminated based on an interim assessment of immunogenicity.

Clinical • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) - P1; N=252; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) - 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

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (clinicaltrials.gov) - P1; N=252; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • PCR

Dose Ranging Trial to Assess Safety and Immunogenicity of V590 in Healthy Adults (V590-001) (clinicaltrials.gov) - P1; N=252; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease