Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021.

Autor: Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA., Marcelin JR; Division of Infectious Diseases, Department of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA., Pettifor AE; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Janes H; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Brown E; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Neradilek M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Yen C; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA., Andriesen J; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Grunenberg N; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Espy N; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Trahey M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA., Fischer RSB; Department of Epidemiology and Biostatistics, School of Public Health, Texas A&M University, College Station, Texas, USA., DeSouza CA; Department of Integrative Physiology, University of Colorado, Boulder, Colorado, USA., Shisler JL; Department of Microbiology, University of Illinois, Urbana, Illinois, USA., Connick E; Department of Medicine, University of Arizona, Tucson, Arizona, USA., Houpt ER; Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia, USA., Chu HY; Department of Medicine, University of Washington, Seattle, Washington, USA., McCulloh RJ; Children's Hospital and Medical Center, University of Nebraska Medical Center, Omaha, Nebraska, USA., Becker-Dreps S; Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Vielot NA; Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Kalbaugh CA; Department of Public Health Sciences, Clemson University, Clemson, South Carolina, USA., Cherabuddi K; Department of Medicine, University of Florida, Gainesville, Florida, USA., Krueger KM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Rosenberg M; Center for Sexual Health Promotion, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA., Greenberg RN; Department of Medicine, University of Kentucky, Lexington, Kentucky, USA., Joaquin A; Department of Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California, USA., Immergluck LC; Department of Microbiology, Biochemistry and Immunology, Morehouse School of Medicine, Atlanta, Georgia, USA., Corey L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.; Department of Medicine, University of Washington, Seattle, Washington, USA.; Department of Laboratory Medicine, University of Washington,Seattle, Washington, USA., Kublin JG; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2023 Nov 02; Vol. 10 (11), pp. ofad511. Date of Electronic Publication: 2023 Nov 02 (Print Publication: 2023).
DOI: 10.1093/ofid/ofad511
Abstrakt: Background: The efficacy of messenger RNA (mRNA)-1273 against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is not well defined, particularly among young adults.
Methods: Adults aged 18-29 years with no known history of SARS-CoV-2 infection or prior vaccination for coronavirus disease 2019 (COVID-19) were recruited from 44 US sites from 24 March to 13 September 2021 and randomized 1:1 to immediate vaccination (receipt of 2 doses of mRNA-1273 vaccine at months 0 and 1) or the standard of care (receipt of COVID-19 vaccine). Randomized participants were followed up for SARS-CoV-2 infection measured by nasal swab testing and symptomatic COVID-19 measured by nasal swab testing plus symptom assessment and assessed for the primary efficacy outcome. A vaccine-declined observational group was also recruited from 16 June to 8 November 2021 and followed up for SARS-CoV-2 infection as specified for the randomized participants.
Results: The study enrolled 1149 in the randomized arms and 311 in the vaccine-declined group and collected >122 000 nasal swab samples. Based on randomized participants, the efficacy of 2 doses of mRNA-1273 vaccine against SARS-CoV-2 infection was 52.6% (95% confidence interval, -14.1% to 80.3%), with the majority of infections due to the Delta variant. Vaccine efficacy against symptomatic COVID-19 was 71.0% (95% confidence interval, -9.5% to 92.3%). Precision was limited owing to curtailed study enrollment and off-study vaccination censoring. The incidence of SARS-CoV-2 infection in the vaccine-declined group was 1.8 times higher than in the standard-of-care group.
Conclusions: mRNA-1273 vaccination reduced the incidence of SARS-CoV-2 infection from March to September 2021, but vaccination was only one factor influencing risk.
Clinical Trials Registration: NCT04811664.
Competing Interests: Potential conflicts of interest. All authors: No reported conflicts.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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