Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults
In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local and systemic adverse reactions occurred more often with the vaccine.
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| Vydáno v: | The New England journal of medicine Ročník 389; číslo 24; s. 2233 - 2244 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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United States
Massachusetts Medical Society
14.12.2023
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| ISSN: | 0028-4793, 1533-4406, 1533-4406 |
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| Abstract | In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local and systemic adverse reactions occurred more often with the vaccine. |
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| AbstractList | Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation.BACKGROUNDRespiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation.In this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed.METHODSIn this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed.Overall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group.RESULTSOverall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group.A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.).CONCLUSIONSA single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.). In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local and systemic adverse reactions occurred more often with the vaccine. AbstractBackgroundRespiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation.MethodsIn this ongoing, randomized, double-blind, placebo-controlled, phase 2–3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed.ResultsOverall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group.ConclusionsA single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.) Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation. In this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed. Overall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group. A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.). |
| Author | Kapoor, Archana Ghaswalla, Parinaz Du, Jiejun Doreski, Pablo A. Mehta, Shraddha Perez-Marc, Gonzalo Panozzo, Catherine A. Zaman, Khalequ Monroy, Jorge Dhar, Rakesh Miller, Jacqueline M. Goswami, Jaya Walsh, Edward E. Simorellis, Alana K. Stoszek, Sonia K. Falsey, Ann R. Wilson, Eleanor Kuter, Barbara J. Das, Rituparna Reuter, Caroline Slobod, Karen Pérez-Breva, Lina Rämet, Mika Wilson, Lauren Shaw, Christine A. Lan, Lan Baqui, Abdullah H. Duncan, Christopher J.A. Mithani, Runa Huang, Wenmei Ujiie, Mugen Schödel, Florian Chen, Grace L. |
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Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 13 givenname: Edward E. surname: Walsh fullname: Walsh, Edward E. organization: From Moderna, Cambridge, MA (E.W., J.G., R. 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Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 14 givenname: Rakesh surname: Dhar fullname: Dhar, Rakesh organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 15 givenname: Lauren orcidid: 0009-0004-0692-4201 surname: Wilson fullname: Wilson, Lauren organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 16 givenname: Jiejun surname: Du fullname: Du, Jiejun organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 17 givenname: Parinaz surname: Ghaswalla fullname: Ghaswalla, Parinaz organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 18 givenname: Archana surname: Kapoor fullname: Kapoor, Archana organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 19 givenname: Lan surname: Lan fullname: Lan, Lan organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 20 givenname: Shraddha surname: Mehta fullname: Mehta, Shraddha organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 21 givenname: Runa surname: Mithani fullname: Mithani, Runa organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 22 givenname: Catherine A. surname: Panozzo fullname: Panozzo, Catherine A. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 23 givenname: Alana K. surname: Simorellis fullname: Simorellis, Alana K. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 24 givenname: Barbara J. surname: Kuter fullname: Kuter, Barbara J. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 25 givenname: Florian surname: Schödel fullname: Schödel, Florian organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 26 givenname: Wenmei surname: Huang fullname: Huang, Wenmei organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 27 givenname: Caroline surname: Reuter fullname: Reuter, Caroline organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 28 givenname: Karen surname: Slobod fullname: Slobod, Karen organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 29 givenname: Sonia K. surname: Stoszek fullname: Stoszek, Sonia K. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 30 givenname: Christine A. surname: Shaw fullname: Shaw, Christine A. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 31 givenname: Jacqueline M. surname: Miller fullname: Miller, Jacqueline M. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 32 givenname: Rituparna surname: Das fullname: Das, Rituparna organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) – sequence: 33 givenname: Grace L. surname: Chen fullname: Chen, Grace L. organization: From Moderna, Cambridge, MA (E.W., J.G., R. Dhar, L.W., J.D., P.G., A.K., L.L., S.M., R.M., C.A.P., A.K.S., B.J.K., F.S., W.H., C.R., K.S., S.K.S., C.A.S., J.M.M., R. Das, G.L.C.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B.); Fundación Respirar–Vaccine Research Division (P.A.D.) and Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (G.P.-M.) — both in Buenos Aires; International Center for Diarrheal Disease Research, Dhaka, Bangladesh (K.Z.); Clinical Site Partners, Winter Park, FL (J.M.); Translational and Clinical Research Institute, Newcastle University, and the National Institute for Health and Care Research Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust — both in Newcastle upon Tyne, United Kingdom (C.J.A.D.); Center Hospital of the National Center for Global Health and Medicine, Tokyo (M.U.); Rokotetutkimusklinikka, Järvenpää, and Finnish Vaccine Research, Tampere — both in Finland (M.R.); Vaccine Research–Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO) Public Health, Valencia, Spain (L.P.-B.); and the University of Rochester, Rochester, NY (A.R.F., E.E.W.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38091530$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Borobia Perez, Alberto Blank, Stephen Breedt, Johannes Cohen, Harris Desai, Nitinchandra Bradley, Paul Hemmersmeier, John Berteau, Tammy Agarwal, Puneet Ampajwala, Madhavi Haranaka, Miwa Bordon, Jose Damian Hernandez, Matilde Deseda, Carmen Choi, Melissa Badenhorst, Josias Servaas Baron, Mira Grayson-Mathis, Charlotte Ensz, David Colville, Bonnie Denham, Douglas De Francisco, Don Fitzgibbons, William Flanagan, Clinton Glaves, Matthew Bisshop, Fiona Buntinx, Erik Campos Barker, Maria Boone, Gary Burgher, Abram Fuller, Ashley Carrillo Castro, Jaime Freeman, George Brazg, Ronald Brahmbhatt, Gaurang Chan, Yvonne Fu Zi Fuller, Gregory Aazami, Hessam Finley, Jon Fujino, Minoru Choo, Eun-Ju Acevedo Diaz, Elia Enid Bergthold, James Brosz, Adam Buynak, Robert Han, Sang Hoon Dennis, Patrick Fitz-Patrick, David Chang, Margaret Cotugno, Michael Alvarado, Hilario Chaparro, Gustavo Cesarz, Marek Fierro, Carlos Bernstein, Richard Goecke Hochberger, Bernardo Chandler, Reynaldo Berman, Gary Casey, Sherri Guzman Romero, Ana Karla Abitbol, Alexander Gerdis, Michae |
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| Snippet | In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local... Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the... AbstractBackgroundRespiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345,... |
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| SubjectTerms | Aged Aging Aging General Antibodies, Viral Chronic obstructive pulmonary disease Clinical Medicine Clinical Medicine General Clinical trials Confidence intervals Critical Care Critical Care General Double-Blind Method Geriatrics Glycoproteins Humans Infections Infectious Disease Infectious Disease General Middle Aged Morbidity mRNA mRNA Vaccines - adverse effects mRNA Vaccines - therapeutic use Older people Outpatient-Based Clinical Medicine Placebos Product development Pulmonary Respiratory diseases Respiratory syncytial virus Respiratory Syncytial Virus Infections - epidemiology Respiratory Syncytial Virus Infections - prevention & control Respiratory Syncytial Virus Vaccines - adverse effects Respiratory Syncytial Virus Vaccines - therapeutic use Respiratory Syncytial Virus, Human - genetics Respiratory tract diseases Respiratory Tract Diseases - diagnosis Respiratory Tract Diseases - epidemiology Respiratory Tract Diseases - prevention & control Safety Side effects Statistical analysis Success Treatment Outcome Vaccine efficacy Vaccines Viral Infections |
| SubjectTermsDisplay | Clinical Medicine Clinical Medicine General Geriatrics/Aging Geriatrics/Aging General Infectious Disease Infectious Disease General Outpatient-Based Clinical Medicine Pulmonary/Critical Care Pulmonary/Critical Care General Vaccines Viral Infections |
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| Title | Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults |
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