Evidence map›Paper›PMID 38873124›Full record

ArticleClinical & translational immunology2024

Serum AZD7442 (tixagevimab-cilgavimab) concentrations and

Lindsay E Clegg, Oleg Stepanov, Sam Matthews, Tom White, Seth Seegobin, Steven Thomas, Kevin M Tuffy, Mats Någård, Mark T Esser, Katie Streicher and 2 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Clinical & translational immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04507256 phase1completednot on this map

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults

TypeinterventionalSponsorAstraZenecaRan2020 to 2021Enrolled60ConditionsCOVID-19ArmsAZD7442, Placebo
NCT04625725 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled5,197ConditionsCOVID-19ArmsAZD7442, Placebo
NCT04723394 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults

TypeinterventionalSponsorAstraZenecaRan2021 to 2022Enrolled910ConditionsCOVID-19ArmsAZD7442, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Lindsay E CleggClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Gaithersburg MD USA.
Oleg StepanovClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Cambridge UK.
Sam MatthewsBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Cambridge UK.
Tom WhiteBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Cambridge UK.
Seth SeegobinBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Cambridge UK.
Steven ThomasBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Durham NC USA.
Kevin M TuffyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Gaithersburg MD USA.
Mats NågårdClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Gaithersburg MD USA.
Mark T EsserVaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Gaithersburg MD USA.
Katie StreicherTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Gaithersburg MD USA.
Taylor S CohenVaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Gaithersburg MD USA.
Anastasia A AksyukTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D AstraZeneca Gaithersburg MD USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: The evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) necessitates rapid methods for assessing monoclonal antibody (mAb) potency against emerging variants. Authentic virus neutralisation assays are considered the gold standard for measuring virus-neutralising antibody (nAb) titres in serum. However, authentic virus-based assays pose inherent practical challenges for measuring nAb titres against emerging SARS-CoV-2 variants (e.g. storing infectious viruses and testing at biosafety level-3 facilities). Here, we demonstrate the utility of pseudovirus neutralisation assay data in conjunction with serum mAb concentrations to robustly predict nAb titres in serum. Methods: SARS-CoV-2 nAb titres were determined via authentic- and lentiviral pseudovirus-based neutralisation assays using serological data from three AZD7442 (tixagevimab-cilgavimab) studies: PROVENT (NCT04625725), TACKLE (NCT04723394) and a phase 1 dose-ranging study (NCT04507256). AZD7442 serum concentrations were assessed using immunocapture. Serum-based half-maximal inhibitory concentration (IC Results: nAb titres measured via authentic- and lentiviral pseudovirus-based neutralisation assays were strongly correlated for the ancestral SARS-CoV-2 virus and SARS-CoV-2 Alpha. Serum AZD7442 concentrations and pseudovirus nAb titres were strongly correlated for multiple SARS-CoV-2 variants with all Spearman correlation coefficients ≥ 0.78. Serum-based IC Conclusions: These data highlight that serum mAb concentrations and pseudovirus

Indexed as

authentic virus assayAZD7442 (tixagevimab–cilgavimab)COVID‐19 monoclonal antibodiespharmacokineticspseudovirus assaySARS‐CoV‐2 neutralising antibody titres

Identifiers

PMID38873124
PMCPMC11175839

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.