New England Journal of Medicine, volume 386, issue 23, pages 2188-2200
Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19
M. J. Levin
1
,
Andrew Ustianowski
1
,
Stéphane De Wit
1
,
Odile Launay
1
,
Miles Avila
1
,
Alison Templeton
1
,
Yuan Yuan
1
,
Seth Seegobin
1
,
Adam Ellery
1
,
Dennis J. Levinson
1
,
Philip Ambery
1
,
Rosalinda H. Arends
1
,
Rohini Beavon
1
,
Kanika Dey
1
,
Pedro Garbes
1
,
Elizabeth Kelly
1
,
Gavin C. K. W. Koh
1
,
Karen A. Near
1
,
Kelly W. Padilla
1
,
Konstantina Psachoulia
1
,
Audrey Sharbaugh
1
,
Katie Streicher
1
,
Menelas N. Pangalos
1
,
Mark T Esser
1
Publication type: Journal Article
Publication date: 2022-04-20
Journal:
New England Journal of Medicine
Quartile SCImago
Q1
Quartile WOS
Q1
Impact factor: 158.5
ISSN: 00284793, 15334406
General Medicine
Abstract
The monoclonal-antibody combination AZD7442 is composed of tixagevimab and cilgavimab, two neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that have an extended half-life and have been shown to have prophylactic and therapeutic effects in animal models. Pharmacokinetic data in humans indicate that AZD7442 has an extended half-life of approximately 90 days.In an ongoing phase 3 trial, we enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both. Participants were randomly assigned in a 2:1 ratio to receive a single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo, and they were followed for up to 183 days in the primary analysis. The primary safety end point was the incidence of adverse events after a single dose of AZD7442. The primary efficacy end point was symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay) occurring after administration of AZD7442 or placebo and on or before day 183.A total of 5197 participants underwent randomization and received one dose of AZD7442 or placebo (3460 in the AZD7442 group and 1737 in the placebo group). The primary analysis was conducted after 30% of the participants had become aware of their randomized assignment. In total, 1221 of 3461 participants (35.3%) in the AZD7442 group and 593 of 1736 participants (34.2%) in the placebo group reported having at least one adverse event, most of which were mild or moderate in severity. Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group and in 17 of 1731 participants (1.0%) in the placebo group (relative risk reduction, 76.7%; 95% confidence interval [CI], 46.0 to 90.0; P<0.001); extended follow-up at a median of 6 months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4). Five cases of severe or critical Covid-19 and two Covid-19-related deaths occurred, all in the placebo group.A single dose of AZD7442 had efficacy for the prevention of Covid-19, without evident safety concerns. (Funded by AstraZeneca and the U.S. government; PROVENT ClinicalTrials.gov number, NCT04625725.).
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Levin M. J. et al. Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19 // New England Journal of Medicine. 2022. Vol. 386. No. 23. pp. 2188-2200.
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Levin M. J., Ustianowski A., De Wit S., Launay O., Avila M., Templeton A., Yuan Y., Seegobin S., Ellery A., Levinson D. J., Ambery P., Arends R. H., Beavon R., Dey K., Garbes P., Kelly E., Koh G. C. K. W., Near K. A., Padilla K. W., Psachoulia K., Sharbaugh A., Streicher K., Pangalos M. N., Esser M. T. Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19 // New England Journal of Medicine. 2022. Vol. 386. No. 23. pp. 2188-2200.
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TY - JOUR
DO - 10.1056/NEJMoa2116620
UR - https://doi.org/10.1056/NEJMoa2116620
TI - Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19
T2 - New England Journal of Medicine
AU - Levin, M. J.
AU - Ustianowski, Andrew
AU - De Wit, Stéphane
AU - Launay, Odile
AU - Avila, Miles
AU - Templeton, Alison
AU - Yuan, Yuan
AU - Seegobin, Seth
AU - Ellery, Adam
AU - Levinson, Dennis J.
AU - Ambery, Philip
AU - Arends, Rosalinda H.
AU - Beavon, Rohini
AU - Dey, Kanika
AU - Garbes, Pedro
AU - Kelly, Elizabeth
AU - Koh, Gavin C. K. W.
AU - Near, Karen A.
AU - Padilla, Kelly W.
AU - Psachoulia, Konstantina
AU - Sharbaugh, Audrey
AU - Streicher, Katie
AU - Pangalos, Menelas N.
AU - Esser, Mark T
PY - 2022
DA - 2022/04/20 00:00:00
PB - NEJM Group
SP - 2188-2200
IS - 23
VL - 386
SN - 0028-4793
SN - 1533-4406
ER -
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@article{2022_Levin,
author = {M. J. Levin and Andrew Ustianowski and Stéphane De Wit and Odile Launay and Miles Avila and Alison Templeton and Yuan Yuan and Seth Seegobin and Adam Ellery and Dennis J. Levinson and Philip Ambery and Rosalinda H. Arends and Rohini Beavon and Kanika Dey and Pedro Garbes and Elizabeth Kelly and Gavin C. K. W. Koh and Karen A. Near and Kelly W. Padilla and Konstantina Psachoulia and Audrey Sharbaugh and Katie Streicher and Menelas N. Pangalos and Mark T Esser},
title = {Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19},
journal = {New England Journal of Medicine},
year = {2022},
volume = {386},
publisher = {NEJM Group},
month = {apr},
url = {https://doi.org/10.1056/NEJMoa2116620},
number = {23},
pages = {2188--2200},
doi = {10.1056/NEJMoa2116620}
}
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Levin, M. J., et al. “Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19.” New England Journal of Medicine, vol. 386, no. 23, Apr. 2022, pp. 2188-2200. https://doi.org/10.1056/NEJMoa2116620.