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Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Background Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age. Method...
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| Published in: | New England Journal of Medicine 2020-12 |
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| creator | Anderson, Evan J Rouphael, Nadine G Widge, Alicia T Jackson, Lisa A Roberts, Paul C Makhene, Mamodikoe Chappell, James D Denison, Mark R Stevens, Laura J Pruijssers, Andrea J McDermott, Adrian B Flach, Britta Lin, Bob C Doria-Rose, Nicole A Sijy O’Dell Schmidt, Stephen D Corbett, Kizzmekia S Swanson, Phillip A Padilla, Marcelino Neuzil, Kathy M Hamilton, Bennett Leav, Brett Makowski, Mat Albert, Jim Cross, Kaitlyn Edara, Venkata Viswanadh Floyd, Katharine Suthar, Mehul S Martinez, David R Baric, Ralph Buchanan, Wendy Luke, Catherine J Phadke, Varun K Rostad, Christina A Ledgerwood, Julie E Graham, Barney S Beigel, John H |
| description | Background Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age. Methods We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. Results Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. Conclusions In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.) |
| doi_str_mv | 10.1056/NEJMoa2028436 |
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Methods We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. Results Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. Conclusions In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.)</description><identifier>DOI: 10.1056/NEJMoa2028436</identifier><language>eng</language><publisher>Waltham: Massachusetts Medical Society</publisher><ispartof>New England Journal of Medicine, 2020-12</ispartof><rights>2020. Not withstanding the ProQuest Terms and Conditions, you may use this content in accordance with the associated terms available at https://www.nejm.org/about-nejm/permissions?query=footer</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c583t-7462f663ca9411e526c5870c52ba1057430039bb399d44f410e52fd580b963e03</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2447091582?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>783,787,27939,38530,43909</link.rule.ids><linktorsrc>$$Uhttps://www.proquest.com/docview/2447091582?pq-origsite=primo$$EView_record_in_ProQuest$$FView_record_in_$$GProQuest</linktorsrc></links><search><creatorcontrib>Anderson, Evan J</creatorcontrib><creatorcontrib>Rouphael, Nadine G</creatorcontrib><creatorcontrib>Widge, Alicia T</creatorcontrib><creatorcontrib>Jackson, Lisa A</creatorcontrib><creatorcontrib>Roberts, Paul C</creatorcontrib><creatorcontrib>Makhene, Mamodikoe</creatorcontrib><creatorcontrib>Chappell, James D</creatorcontrib><creatorcontrib>Denison, Mark R</creatorcontrib><creatorcontrib>Stevens, Laura J</creatorcontrib><creatorcontrib>Pruijssers, Andrea J</creatorcontrib><creatorcontrib>McDermott, Adrian B</creatorcontrib><creatorcontrib>Flach, Britta</creatorcontrib><creatorcontrib>Lin, Bob C</creatorcontrib><creatorcontrib>Doria-Rose, Nicole A</creatorcontrib><creatorcontrib>Sijy O’Dell</creatorcontrib><creatorcontrib>Schmidt, Stephen D</creatorcontrib><creatorcontrib>Corbett, Kizzmekia S</creatorcontrib><creatorcontrib>Swanson, Phillip A</creatorcontrib><creatorcontrib>Padilla, Marcelino</creatorcontrib><creatorcontrib>Neuzil, Kathy M</creatorcontrib><creatorcontrib>Hamilton, Bennett</creatorcontrib><creatorcontrib>Leav, Brett</creatorcontrib><creatorcontrib>Makowski, Mat</creatorcontrib><creatorcontrib>Albert, Jim</creatorcontrib><creatorcontrib>Cross, Kaitlyn</creatorcontrib><creatorcontrib>Edara, Venkata Viswanadh</creatorcontrib><creatorcontrib>Floyd, Katharine</creatorcontrib><creatorcontrib>Suthar, Mehul S</creatorcontrib><creatorcontrib>Martinez, David R</creatorcontrib><creatorcontrib>Baric, Ralph</creatorcontrib><creatorcontrib>Buchanan, Wendy</creatorcontrib><creatorcontrib>Luke, Catherine J</creatorcontrib><creatorcontrib>Phadke, Varun K</creatorcontrib><creatorcontrib>Rostad, Christina A</creatorcontrib><creatorcontrib>Ledgerwood, Julie E</creatorcontrib><creatorcontrib>Graham, Barney S</creatorcontrib><creatorcontrib>Beigel, John H</creatorcontrib><title>Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults</title><title>New England Journal of Medicine</title><description>Background Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age. Methods We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. Results Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. Conclusions In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. 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Methods We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. Results Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. Conclusions In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.)</abstract><cop>Waltham</cop><pub>Massachusetts Medical Society</pub><doi>10.1056/NEJMoa2028436</doi><oa>free_for_read</oa></addata></record> |
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| title | Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults |
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