NETEC Resource Library

Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults

Contenu

Click for External Resource*


Click to read full article*


*The link above may share a zip file (.zip) hosted on repository.netecweb.org. Zip files will download automatically.
*All other links are external and will open in a new window. If you click an external link, you are leaving the NETEC site, and we do not maintain, review, or endorse these materials. See our terms of use.


Item Type

Publication

Terms of Use

By accessing these materials you are agreeing to our terms of use, which may be found here: Terms of Use.

Was this resource helpful?


Titre

Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults

Sujet

Description

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.

Related articles to this were published:
  • Heaton, Penny M. 2020. "The Covid-19 Vaccine-Development Multiverse." New England Journal of Medicine 383 (20):1986-8.
  • Jackson, Lisa A., Evan J. Anderson, Nadine G. Rouphael, Paul C. Roberts, Mamodikoe Makhene, Rhea N. Coler, Michele P. McCullough, James D. Chappell, Mark R. Denison, Laura J. Stevens, Andrea J. Pruijssers, Adrian McDermott, Britta Flach, Nicole A. Doria-Rose, Kizzmekia S. Corbett, Kaitlyn M. Morabito, Sijy O’Dell, Stephen D. Schmidt, Phillip A. Swanson, Marcelino Padilla, John R. Mascola, Kathleen M. Neuzil, Hamilton Bennett, Wellington Sun, Etza Peters, Mat Makowski, Jim Albert, Kaitlyn Cross, Wendy Buchanan, Rhonda Pikaart-Tautges, Julie E. Ledgerwood, Barney S. Graham, and John H. Beigel. 2020. "An mRNA Vaccine against SARS-CoV-2 — Preliminary Report." New England Journal of Medicine.
  • Widge, Alicia T., Nadine G. Rouphael, Lisa A. Jackson, Evan J. Anderson, Paul C. Roberts, Mamodikoe Makhene, James D. Chappell, Mark R. Denison, Laura J. Stevens, Andrea J. Pruijssers, Adrian B. McDermott, Britta Flach, Bob C. Lin, Nicole A. Doria-Rose, Sijy O’Dell, Stephen D. Schmidt, Kathleen M. Neuzil, Hamilton Bennett, Brett Leav, Mat Makowski, Jim Albert, Kaitlyn Cross, Venkata-Viswanadh Edara, Katharine Floyd, Mehul S. Suthar, Wendy Buchanan, Catherine J. Luke, Julie E. Ledgerwood, John R. Mascola, Barney S. Graham, and John H. Beigel. 2020. "Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination." New England Journal of Medicine 384 (1):80-2.

Date

2020-12-17

Citer ce document

Anderson, Evan J., Nadine G. Rouphael, Alicia T. Widge, Lisa A. Jackson, Paul C. Roberts, Mamodikoe Makhene, James D. Chappell, Mark R. Denison, Laura J. Stevens, Andrea J. Pruijssers, Adrian B. McDermott, Britta Flach, Bob C. Lin, Nicole A. Doria-Rose, Sijy O’Dell, Stephen D. Schmidt, Kizzmekia S. Corbett, Phillip A. Swanson, Marcelino Padilla, Kathy M. Neuzil, Hamilton Bennett, Brett Leav, Mat Makowski, Jim Albert, Kaitlyn Cross, Venkata Viswanadh Edara, Katharine Floyd, Mehul S. Suthar, David R. Martinez, Ralph Baric, Wendy Buchanan, Catherine J. Luke, Varun K. Phadke, Christina A. Rostad, Julie E. Ledgerwood, Barney S. Graham, and John H. Beigel. 2020. "Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults." New England Journal of Medicine 383 (25):2427-38.

Résumé

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. opens in new tab.)

Accessibilité

Free online on NEJM.

Collection