Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults
Abstract Background An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults. Methods Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, react...
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| Published in: | The Journal of infectious diseases Vol. 230; no. 3; pp. e647 - e656 |
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| Main Authors: | , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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Oxford University Press
23.09.2024
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| ISSN: | 0022-1899, 1537-6613, 1537-6613 |
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| Abstract | Abstract
Background
An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.
Methods
Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months.
Results
Overall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2–16.5; RSV-B, 5.3–12.5; preF bAb, 7.2–12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs.
Conclusions
mRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster.
Clinical Trials Registration
NCT04528719 (ClinicalTrials.gov).
Older adults and those with comorbidities are at increased risk of severe RSV. We assessed the safety and immunogenicity of mRNA-1345, an RSV vaccine, in adults aged 65 to 79 years. mRNA-1345 was well tolerated and immunogenic following a single injection and 12-month booster. |
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| AbstractList | Abstract
Background
An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.
Methods
Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months.
Results
Overall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2–16.5; RSV-B, 5.3–12.5; preF bAb, 7.2–12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs.
Conclusions
mRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster.
Clinical Trials Registration
NCT04528719 (ClinicalTrials.gov).
Older adults and those with comorbidities are at increased risk of severe RSV. We assessed the safety and immunogenicity of mRNA-1345, an RSV vaccine, in adults aged 65 to 79 years. mRNA-1345 was well tolerated and immunogenic following a single injection and 12-month booster. An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.BACKGROUNDAn mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months.METHODSBased on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months.Overall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2-16.5; RSV-B, 5.3-12.5; preF bAb, 7.2-12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs.RESULTSOverall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2-16.5; RSV-B, 5.3-12.5; preF bAb, 7.2-12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs.mRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster.CONCLUSIONSmRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster.NCT04528719 (ClinicalTrials.gov).CLINICAL TRIALS REGISTRATIONNCT04528719 (ClinicalTrials.gov). An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults. Based on a randomized, observer-blind, placebo-controlled design, this phase 1 dose-ranging study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1345 in adults aged 65 to 79 years. Participants were randomized to receive 1 dose of mRNA-1345 (12.5, 25, 50, 100, or 200 µg) or placebo and matched mRNA-1345 booster or placebo at 12 months. Overall, 298 participants received the first injection and 247 received the 12-month booster injection. mRNA-1345 was generally well tolerated after both injections, with the most frequently reported solicited adverse reactions being injection site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection but with severity, time to onset, and duration similar to the first injection. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers and prefusion F binding antibody (preF bAb) concentrations at 1 month (geometric mean fold rises: RSV-A, 10.2-16.5; RSV-B, 5.3-12.5; preF bAb, 7.2-12.1). RSV antibody levels remained above baseline through 12 months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B neutralizing antibody titers and preF bAb concentrations; titers after booster injection were numerically lower than those after the first dose, with overlapping 95% CIs. mRNA-1345 was well tolerated and immunogenic following a single injection and a 12-month booster. NCT04528719 (ClinicalTrials.gov). |
| Author | Kapoor, Archana Das, Rituparna Harper, Charles Reuter, Caroline Wilson, Lauren Panozzo, Catherine A Stoszek, Sonia K Shaw, Christine A Mithani, Runa Dhar, Rakesh Guo, Ruiting Goswami, Jaya Chen, Grace L Wilson, Eleanor Simorellis, Alana K Essink, Brandon |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38385566$$D View this record in MEDLINE/PubMed |
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| Keywords | older adult safety and immunogenicity mRNA-1345 respiratory syncytial virus mRNA vaccine |
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Background
An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older... An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults. Based on a... An mRNA-based respiratory syncytial virus (RSV) vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults.BACKGROUNDAn... |
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| SubjectTerms | Aged Antibodies, Neutralizing - blood Antibodies, Viral - blood Female Humans Immunization, Secondary Immunogenicity, Vaccine Male mRNA Vaccines Respiratory Syncytial Virus Infections - immunology Respiratory Syncytial Virus Infections - prevention & control Respiratory Syncytial Virus Vaccines - administration & dosage Respiratory Syncytial Virus Vaccines - adverse effects Respiratory Syncytial Virus Vaccines - immunology Respiratory Syncytial Virus, Human - genetics Respiratory Syncytial Virus, Human - immunology RNA, Messenger - genetics RNA, Messenger - immunology Vaccines, Synthetic - administration & dosage Vaccines, Synthetic - adverse effects Vaccines, Synthetic - immunology |
| Title | Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults |
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