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P1/2 data, Journal: A measles-vectored vaccine candidate expressing prefusion-stabilized SARS-CoV-2 spike protein brought to phase I/II clinical trials: protection of African green monkeys from COVID-19 disease. (Pubmed Central) - Apr 2, 2024 Here, we evaluate a measles virus (MV)-vectored vaccine expressing a stabilized prefusion SARS-CoV-2 spike (S) protein (MV-ATU3-S2P?F2A; V591) with demonstrated immunogenicity in mouse models (see companion article [J...This study uses a safe and effective measles vaccine as a platform for vaccination against SARS-CoV-2...After challenge, these AGMs produced less virus in mucosal secretions, for a shorter period, and had a reduced disease burden in the lungs compared to control animals. At necropsy, lower levels of viral RNA were detected in tissue samples from vaccinated animals, and the lungs of these animals lacked the histologic hallmarks of SARS-CoV-2 disease observed exclusively in the control AGMs.
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Clinical, P1/2 data, Clinical Trial,Phase II, Journal: Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial. (Pubmed Central) - Feb 2, 2022 P1/2 At necropsy, lower levels of viral RNA were detected in tissue samples from vaccinated animals, and the lungs of these animals lacked the histologic hallmarks of SARS-CoV-2 disease observed exclusively in the control AGMs. V591 was generally well tolerated, but immunogenicity was insufficient to warrant continued development.
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Clinical, P1 data, Journal: Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study. (Pubmed Central) - Feb 2, 2022 P1 V591 was generally well tolerated, but immunogenicity was insufficient to warrant continued development. While V591 was generally well tolerated, the immunogenicity was not sufficient to support further development.
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Journal: Use of Stability Modeling to Support Accelerated Vaccine Development and Supply. (Pubmed Central) - Oct 28, 2021 It is demonstrated that modeling methodologies need to be tailored to the nature of the vaccine, the available prior knowledge, and the monitored attributes. Considering that the well-established strategies reported in ICH or WHO guidelines are not always broadly applicable to vaccines, this article represents an important source of information for vaccine researchers and manufacturers, setting the grounds for further discussion within the vaccine industry and with regulators.
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Trial completion: COVID-19-101: Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine (clinicaltrials.gov) - Jul 8, 2021 P1, N=90, Completed, Considering that the well-established strategies reported in ICH or WHO guidelines are not always broadly applicable to vaccines, this article represents an important source of information for vaccine researchers and manufacturers, setting the grounds for further discussion within the vaccine industry and with regulators. Active, not recruiting --> Completed
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Enrollment closed, Trial completion date, Trial primary completion date: COVID-19-101: Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine (clinicaltrials.gov) - Apr 8, 2021 P1, N=90, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Jul 2021 | Trial primary completion date: Nov 2020 --> Jun 2021
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Trial termination: A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) (clinicaltrials.gov) - Mar 10, 2021 P1/2, N=263, Terminated, Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Jul 2021 | Trial primary completion date: Nov 2020 --> Jun 2021 Active, not recruiting --> Terminated; The study was terminated based on an interim assessment of immunogenicity
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Trial completion date, Trial primary completion date: A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) (clinicaltrials.gov) - Mar 3, 2021 P1/2, N=260, Active, not recruiting, Active, not recruiting --> Terminated; The study was terminated based on an interim assessment of immunogenicity Trial completion date: Apr 2022 --> Mar 2021 | Trial primary completion date: Apr 2022 --> Mar 2021
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Enrollment closed: A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) (clinicaltrials.gov) - Dec 7, 2020 P1/2, N=260, Active, not recruiting, Trial completion date: Apr 2022 --> Mar 2021 | Trial primary completion date: Apr 2022 --> Mar 2021 Recruiting --> Active, not recruiting
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