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
Summary: Background: Vaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate. Methods: In this placebo-controlled, doub...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | EBioMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S235239642200319X |
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| author | Jonathan A. Robbins Dereck Tait Qinlei Huang Sheri Dubey Tami Crumley Josee Cote Julie Luk Jeffrey R. Sachs Kathryn Rutkowski Harriet Park Robert Schwab William Joseph Howitt Juan Carlos Rondon Martha Hernandez-Illas Terry O'Reilly William Smith Jakub Simon Cathy Hardalo Xuemei Zhao Richard Wnek Alethea Cope Eseng Lai Paula Annunziato Dalya Guris S. Aubrey Stoch |
| author_facet | Jonathan A. Robbins Dereck Tait Qinlei Huang Sheri Dubey Tami Crumley Josee Cote Julie Luk Jeffrey R. Sachs Kathryn Rutkowski Harriet Park Robert Schwab William Joseph Howitt Juan Carlos Rondon Martha Hernandez-Illas Terry O'Reilly William Smith Jakub Simon Cathy Hardalo Xuemei Zhao Richard Wnek Alethea Cope Eseng Lai Paula Annunziato Dalya Guris S. Aubrey Stoch |
| author_sort | Jonathan A. Robbins |
| collection | DOAJ |
| description | Summary: Background: Vaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate. Methods: In this placebo-controlled, double-blind, three-part phase 1 study, healthy adults were randomised to receive a single intramuscular dose of vaccine or placebo. In Part 1, younger (18–54 years) and, in Part 2, older (≥55 years) adults seronegative for SARS-CoV-2 nucleocapsid received one of four V590 dose levels (5.00 × 105; 2.40 × 106; 1.15 × 107; or 5.55 × 107 plaque-forming units [pfu]) or placebo. In Part 3, a single V590 dose level (5.55 × 10⁷ pfu) or placebo was administered to younger SARS-CoV-2 seropositive adults. Primary endpoints included adverse events (AEs) and for Parts 1 and 2 anti-SARS-CoV-2 serum neutralising antibody responses measured by 50% plaque reduction neutralisation (PRNT50) assay at Day 28. Registration NCT04569786 [P001-02]. Findings: 232 participants were randomised and 219 completed the study. In seronegative participants, anti-SARS-CoV-2 spike-specific antibody responses to V590 were low and comparable to placebo across the lower dose levels. At the highest dose level (5.55 × 107 pfu), anti-SARS-CoV-2 spike-specific PRNT50 was 2.3-fold higher than placebo. The most frequently reported AEs were injection-site pain (38.4%), headache (15.1%) and fatigue (13.4%). Interpretation: 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. Funding: The study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. |
| first_indexed | 2024-04-13T22:10:57Z |
| format | Article |
| id | doaj.art-a44da410c7ec4f96838eaf6361e76d18 |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-04-13T22:10:57Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-a44da410c7ec4f96838eaf6361e76d182022-12-22T02:27:43ZengElsevierEBioMedicine2352-39642022-08-0182104138Safety 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 trialJonathan A. Robbins0Dereck Tait1Qinlei Huang2Sheri Dubey3Tami Crumley4Josee Cote5Julie Luk6Jeffrey R. Sachs7Kathryn Rutkowski8Harriet Park9Robert Schwab10William Joseph Howitt11Juan Carlos Rondon12Martha Hernandez-Illas13Terry O'Reilly14William Smith15Jakub Simon16Cathy Hardalo17Xuemei Zhao18Richard Wnek19Alethea Cope20Eseng Lai21Paula Annunziato22Dalya Guris23S. Aubrey Stoch24Merck & Co., Inc., Rahway, New Jersey, USA; Corresponding author.The International AIDS Vaccine Initiative, Inc. (IAVI), New York, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USAThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USACelerion, Lincoln, Nebraska, USABio-Kinetic Clinical Applications (QPS), Missouri, USAClinical Pharmacology of Miami, Florida, USAQPS Miami Research Associates, Florida, USACelerion, Lincoln, Nebraska, USAAlliance for Multispecialty Research, LLC, Knoxville, Tennessee, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USAMerck & Co., Inc., Rahway, New Jersey, USASummary: Background: Vaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate. Methods: In this placebo-controlled, double-blind, three-part phase 1 study, healthy adults were randomised to receive a single intramuscular dose of vaccine or placebo. In Part 1, younger (18–54 years) and, in Part 2, older (≥55 years) adults seronegative for SARS-CoV-2 nucleocapsid received one of four V590 dose levels (5.00 × 105; 2.40 × 106; 1.15 × 107; or 5.55 × 107 plaque-forming units [pfu]) or placebo. In Part 3, a single V590 dose level (5.55 × 10⁷ pfu) or placebo was administered to younger SARS-CoV-2 seropositive adults. Primary endpoints included adverse events (AEs) and for Parts 1 and 2 anti-SARS-CoV-2 serum neutralising antibody responses measured by 50% plaque reduction neutralisation (PRNT50) assay at Day 28. Registration NCT04569786 [P001-02]. Findings: 232 participants were randomised and 219 completed the study. In seronegative participants, anti-SARS-CoV-2 spike-specific antibody responses to V590 were low and comparable to placebo across the lower dose levels. At the highest dose level (5.55 × 107 pfu), anti-SARS-CoV-2 spike-specific PRNT50 was 2.3-fold higher than placebo. The most frequently reported AEs were injection-site pain (38.4%), headache (15.1%) and fatigue (13.4%). Interpretation: 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. Funding: The study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.http://www.sciencedirect.com/science/article/pii/S235239642200319XSARS-CoV-2COVID-19VaccineV590Vesicular stomatitis virus (VSV) |
| spellingShingle | Jonathan A. Robbins Dereck Tait Qinlei Huang Sheri Dubey Tami Crumley Josee Cote Julie Luk Jeffrey R. Sachs Kathryn Rutkowski Harriet Park Robert Schwab William Joseph Howitt Juan Carlos Rondon Martha Hernandez-Illas Terry O'Reilly William Smith Jakub Simon Cathy Hardalo Xuemei Zhao Richard Wnek Alethea Cope Eseng Lai Paula Annunziato Dalya Guris S. Aubrey Stoch 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 EBioMedicine SARS-CoV-2 COVID-19 Vaccine V590 Vesicular stomatitis virus (VSV) |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | SARS-CoV-2 COVID-19 Vaccine V590 Vesicular stomatitis virus (VSV) |
| url | http://www.sciencedirect.com/science/article/pii/S235239642200319X |
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