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All Studies   Meta Analysis    Recent:   

Effect of timing of casirivimab and imdevimab administration relative to mRNA-1273 COVID-19 vaccination on vaccine-induced SARS-CoV-2 neutralising antibody responses: a prospective, open-label, phase 2, randomised controlled trial

Isa et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00421-3, NCT04852978
Sep 2024  
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Symp. case -37% Improvement Relative Risk Casirivimab/i..  Isa et al.  Prophylaxis  RCT Is prophylaxis with casirivimab/imdevimab beneficial for COVID-19? RCT 293 patients in the USA (April 2021 - November 2022) No significant difference in symptomatic cases c19early.org Isa et al., The Lancet Infectious Dise.., Sep 2024 Favorscasirivimab/im.. Favorscontrol 0 0.5 1 1.5 2+
17th treatment shown to reduce risk in March 2021
 
*, now with p = 0.00018 from 31 studies, recognized in 45 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 95 treatments. c19early.org
RCT 293 healthy adults focusing on the timing of casirivimab and imdevimab administration relative to mRNA-1273, but also showing the incidence of COVID-19 for each group, with higher incidence in the casirivimab and imdevimab groups (without statistical significance). Authors note the high prevalence of omicron variants which may explain the lack of efficacy seen.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants1-6.
risk of symptomatic case, 37.1% higher, RR 1.37, p = 0.65, treatment 35 of 245 (14.3%), control 5 of 48 (10.4%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Isa et al., 2 Sep 2024, Randomized Controlled Trial, USA, peer-reviewed, 40 authors, study period 29 April, 2021 - 21 November, 2022, trial NCT04852978 (history). Contact: flonza.isa@regeneron.com.
This PaperCasirivimab/i..All
Effect of timing of casirivimab and imdevimab administration relative to mRNA-1273 COVID-19 vaccination on vaccine-induced SARS-CoV-2 neutralising antibody responses: a prospective, open-label, phase 2, randomised controlled trial
Flonza Isa, PhD Ana M Gonzalez Ortiz, Jonathan Meyer, PhD, B A Olenchock Jennifer D Hamilton, Benjamin A Olenchock, MD Taylor Brackin, MS Samit Ganguly, PhD Eduardo Forleo-Neto, MD Lori Faria, BS Ingeborg Heirman, Prof Mary Marovich, MD Julia Hutter, MD Laura Polakowski, Susan C Irvin, MD Mazhar Thakur, PhD Andrea T Hooper, PhD Alina Baum, Faisal Christopher D Petro, Faisal A Fakih, MD M Juliana Mcelrath, Stephen C De Rosa, Kristen W Cohen, Latonya D Williams, Caleb A Hellman, Ahmad J Odeh, Aloki H Patel, PhD Georgia D Tomaras, MD Gregory P Geba, PhD Christos A Kyratsous, PhD Bret Musser, MD George D Yancopoulos, for the Trial Gary A Herman, Kenneth C Turner, Yunji Kim, George Konis, Mark J Rosenthal, Caryn F Trbovic, Bari Kowal, A Thomas Dicioccio, Paula Dakin
The Lancet Infectious Diseases, doi:10.1016/s1473-3099(24)00421-3
Background Deeper insight is needed on how monoclonal antibodies (mAbs) affect vaccine-mediated immune responses when targeting the same protein. We describe the first prospective randomised trial designed to understand mAb-mediated alterations in vaccine-induced immune responses to SARS-CoV-2 spike protein epitopes. Methods This randomised, open-label, parallel-group study assessed the potential interaction of a mAb combination, casirivimab and imdevimab, with a vaccine, Moderna's mRNA-1273, in healthy SARS-CoV-2 immunologically naive, seronegative adults at six centres in the USA. Participants were randomly assigned (per prespecified randomisation ratios within enrolment waves) according to a computer-generated randomisation scheme, stratified by age (<65 years and ≥65 years), to various intravenous or subcutaneous doses of casirivimab and imdevimab before, after, or at the same time as mRNA-1273 or to mRNA-1273 only. The doses of casirivimab and imdevimab were chosen to mimic various time intervals between receipt of 1200 mg of the mAb and the first dose of a primary series with mRNA-1273. The primary endpoint was vaccine-induced 50% inhibitory dilution neutralising antibody titres to SARS-CoV-2 spike protein, 56 days after the first vaccination. Secondary endpoints included vaccine-induced total antibodies to SARS-CoV-2 antigens and incidence of treatment-emergent adverse events. Exploratory endpoints included blood-derived T-cell and B-cell responses. The per-protocol set was used for the analysis of the primary endpoint and included all randomly assigned participants who received both doses of the vaccine and completed the injection or infusion of casirivimab and imdevimab per protocol, had no evidence of SARS-CoV-2 infection in the past or in the 56 days after the first dose of vaccine, and did not receive any intervention outside of the study that could alter the immune response. Safety was assessed in the safety analysis set, which included all randomly assigned participants who had received one or more doses of mRNA-1273 or any study drug, and analysed based on treatment received. The study is registered with ClinicalTrials.gov, NCT04852978, and is complete. Findings Between April 29, 2021, and Nov 21, 2022, 807 participants were assessed for eligibility and 295 were randomly assigned. 293 participants were included in the safety analysis set and 260 were included in the per-protocol set. All vaccinated participants developed neutralising antibodies to SARS-CoV-2, with median titres above the published protective threshold (100 IU/mL) against the SARS-CoV-2 D614G variant (considered a reference strain at the time the initial COVID-19 vaccines were developed). Titres were decreased up to 4-fold (median titres 280-450 IU/mL for casirivimab and imdevimab vs 1160 IU/mL for vaccine only on day 56) when casirivimab and imdevimab was given 85 days or less before vaccination (150-1200 mg intravenously) or co-administered subcutaneously (600..
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