Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study
This phase 1, open-label, dose-escalation, multi-center study (NCT05477186) assessed the safety and immunogenicity of a booster dose of an mRNA COVID-19 vaccine (CV0501) encoding the SARS-CoV-2 Omicron BA.1 spike protein. Participants aged ≥ 18 years previously vaccinated with ≥ 2 doses of an mRNA C...
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2408863 |
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| author | Brandon J. Essink Craig Shapiro Marie Grace Dawn Isidro Paul Bradley Antoinette Pragalos Mark Bloch Joel Santiaguel Melchor Victor Frias Spiros Miyakis Margarida Alves de Mesquita Stefano Berrè Charlotte Servais Natasha Waugh Claudia Hoffmann Emna Baba Oliver Schönborn-Kellenberger Olaf-Oliver Wolz Sven D. Koch Tapiwa Ganyani Philippe Boutet Philipp Mann Stefan O. Mueller Roshan Ramanathan Martin Robert Gaudinski Nicolas Vanhoutte |
| author_facet | Brandon J. Essink Craig Shapiro Marie Grace Dawn Isidro Paul Bradley Antoinette Pragalos Mark Bloch Joel Santiaguel Melchor Victor Frias Spiros Miyakis Margarida Alves de Mesquita Stefano Berrè Charlotte Servais Natasha Waugh Claudia Hoffmann Emna Baba Oliver Schönborn-Kellenberger Olaf-Oliver Wolz Sven D. Koch Tapiwa Ganyani Philippe Boutet Philipp Mann Stefan O. Mueller Roshan Ramanathan Martin Robert Gaudinski Nicolas Vanhoutte |
| author_sort | Brandon J. Essink |
| collection | DOAJ |
| description | This phase 1, open-label, dose-escalation, multi-center study (NCT05477186) assessed the safety and immunogenicity of a booster dose of an mRNA COVID-19 vaccine (CV0501) encoding the SARS-CoV-2 Omicron BA.1 spike protein. Participants aged ≥ 18 years previously vaccinated with ≥ 2 doses of an mRNA COVID-19 vaccine received CV0501 doses ranging from 12 to 200 μg. After assessment of safety and immunogenicity of the 12 μg dose in 30 adults, 30 adults ≤ 64 years were randomized to receive either a 3 or 6 μg dose. Solicited adverse events (AEs) were collected for 7 days, unsolicited AEs for 28 days, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) until day (D) 181 post-vaccination. Serum neutralizing titers specific to SARS-CoV-2 BA.1, wild-type, Delta, and additional Omicron subvariants were assessed at D1, D15, D29, D91, and D181. Of 180 vaccinated participants (mean age: 49.3 years; 57.8% women), 70.6% had prior SARS-CoV-2 infection. Most solicited local (98.1%) and systemic (96.7%) AEs were of mild-to-moderate severity; the most common were injection site pain (57.5%; 33.3–73.3% across groups) and myalgia (36.9%; 13.3–56.7%). Unsolicited AEs were reported by 14.4% (6.7–26.7%) of participants (mild-to-moderate severity in 88.5% of the participants). Three participants (1.7%) reported SAEs, 16.7% (6.7–30.0%) reported MAAEs, and 8.3% (0.0–13.3%) reported AESIs (15 COVID-19 cases), none related to vaccination. Geometric means of serum neutralizing titers increased from baseline to D15 and D29 (dose-dependent), and then decreased over time. The safety and immunogenicity results supported advancement to a phase 2 trial. |
| format | Article |
| id | doaj-art-b801d4c67eeb429f80a7051c7f35eae6 |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-b801d4c67eeb429f80a7051c7f35eae62025-08-20T02:16:44ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2408863Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation studyBrandon J. Essink0Craig Shapiro1Marie Grace Dawn Isidro2Paul Bradley3Antoinette Pragalos4Mark Bloch5Joel Santiaguel6Melchor Victor Frias7Spiros Miyakis8Margarida Alves de Mesquita9Stefano Berrè10Charlotte Servais11Natasha Waugh12Claudia Hoffmann13Emna Baba14Oliver Schönborn-Kellenberger15Olaf-Oliver Wolz16Sven D. Koch17Tapiwa Ganyani18Philippe Boutet19Philipp Mann20Stefan O. Mueller21Roshan Ramanathan22Martin Robert Gaudinski23Nicolas Vanhoutte24Velocity Clinical Research, Omaha, NE, USACenExel RCA, Hollywood, FL, USAWest Visayas State University, Iloilo, PhilippinesVelocity Clinical Research, Savannah, GA, USACTI Clinical Research Center, Cincinnati, OH, USAHoldsworth House Medical Practice Sydney, Darlinghurst, New South Wales, AustraliaQuirino Memorial Medical Center, Quezon, PhilippinesDe La Salle Medical and Health Sciences Institute, Dasmariñas, Cavite, PhilippinesWollongong Hospital, Wollongong, New South Wales, AustraliaCureVac SE, Wiesbaden, GermanyGSK, Rixensart, BelgiumGSK, Rixensart, BelgiumGSK, Brentford, Middlesex, UKCureVac SE, Wiesbaden, GermanyGSK, Wavre, BelgiumCureVac SE, Wiesbaden, GermanyCureVac SE, Tübingen, GermanyCureVac SE, Tübingen, GermanyGSK, Wavre, BelgiumGSK, Rixensart, BelgiumCureVac SE, Wiesbaden, GermanyCureVac SE, Tübingen, GermanyGSK, Rockville, MD, USAGSK, Rockville, MD, USAGSK, Wavre, BelgiumThis phase 1, open-label, dose-escalation, multi-center study (NCT05477186) assessed the safety and immunogenicity of a booster dose of an mRNA COVID-19 vaccine (CV0501) encoding the SARS-CoV-2 Omicron BA.1 spike protein. Participants aged ≥ 18 years previously vaccinated with ≥ 2 doses of an mRNA COVID-19 vaccine received CV0501 doses ranging from 12 to 200 μg. After assessment of safety and immunogenicity of the 12 μg dose in 30 adults, 30 adults ≤ 64 years were randomized to receive either a 3 or 6 μg dose. Solicited adverse events (AEs) were collected for 7 days, unsolicited AEs for 28 days, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) until day (D) 181 post-vaccination. Serum neutralizing titers specific to SARS-CoV-2 BA.1, wild-type, Delta, and additional Omicron subvariants were assessed at D1, D15, D29, D91, and D181. Of 180 vaccinated participants (mean age: 49.3 years; 57.8% women), 70.6% had prior SARS-CoV-2 infection. Most solicited local (98.1%) and systemic (96.7%) AEs were of mild-to-moderate severity; the most common were injection site pain (57.5%; 33.3–73.3% across groups) and myalgia (36.9%; 13.3–56.7%). Unsolicited AEs were reported by 14.4% (6.7–26.7%) of participants (mild-to-moderate severity in 88.5% of the participants). Three participants (1.7%) reported SAEs, 16.7% (6.7–30.0%) reported MAAEs, and 8.3% (0.0–13.3%) reported AESIs (15 COVID-19 cases), none related to vaccination. Geometric means of serum neutralizing titers increased from baseline to D15 and D29 (dose-dependent), and then decreased over time. The safety and immunogenicity results supported advancement to a phase 2 trial.https://www.tandfonline.com/doi/10.1080/21645515.2024.2408863COVID-19mRNA vaccineboosterSARS-CoV-2 variantssafetyimmunogenicity |
| spellingShingle | Brandon J. Essink Craig Shapiro Marie Grace Dawn Isidro Paul Bradley Antoinette Pragalos Mark Bloch Joel Santiaguel Melchor Victor Frias Spiros Miyakis Margarida Alves de Mesquita Stefano Berrè Charlotte Servais Natasha Waugh Claudia Hoffmann Emna Baba Oliver Schönborn-Kellenberger Olaf-Oliver Wolz Sven D. Koch Tapiwa Ganyani Philippe Boutet Philipp Mann Stefan O. Mueller Roshan Ramanathan Martin Robert Gaudinski Nicolas Vanhoutte Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study Human Vaccines & Immunotherapeutics COVID-19 mRNA vaccine booster SARS-CoV-2 variants safety immunogenicity |
| title | Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study |
| title_full | Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study |
| title_fullStr | Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study |
| title_full_unstemmed | Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study |
| title_short | Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study |
| title_sort | safety and immunogenicity of a modified mrna lipid nanoparticle vaccine candidate against covid 19 results from a phase 1 dose escalation study |
| topic | COVID-19 mRNA vaccine booster SARS-CoV-2 variants safety immunogenicity |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2408863 |
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