Evidence map›Paper›PMID 35781137›Full record

ArticleeLife2022

Process- and product-related impurities in the ChAdOx1 nCov-19 vaccine.

Lea Krutzke, Reinhild Rösler, Ellen Allmendinger, Tatjana Engler, Sebastian Wiese, Stefan Kochanek

Open access · goldAbstract read
In one paragraph

Article in eLife, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
3.8field-weighted citation impact, top 5% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 48 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Lea KrutzkeDepartment of Gene Therapy, University of Ulm, Ulm, Germany.ORCID 0000-0002-4092-4131
Reinhild RöslerCore Unit Mass Spectrometry and Proteomics, University of Ulm, Ulm, Germany.
Ellen AllmendingerDepartment of Gene Therapy, University of Ulm, Ulm, Germany.
Tatjana EnglerDepartment of Gene Therapy, University of Ulm, Ulm, Germany.
Sebastian WieseCore Unit Mass Spectrometry and Proteomics, University of Ulm, Ulm, Germany.
Stefan KochanekDepartment of Gene Therapy, University of Ulm, Ulm, Germany.ORCID 0000-0001-7494-1602
Universität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ChAdOx1 nCov-19 and Ad26.COV2.S are approved vaccines inducing protective immunity against SARS-CoV-2 infection in humans by expressing the Spike protein of SARS-CoV-2. We analyzed protein content and protein composition of ChAdOx1 nCov-19 and Ad26.COV2.S by biochemical methods and by mass spectrometry. Four out of four tested lots of ChAdOx1 nCoV-19 contained significantly higher than expected levels of host cell proteins (HCPs) and of free viral proteins. The most abundant contaminating HCPs belonged to the heat-shock protein and cytoskeletal protein families. The HCP content exceeded the 400 ng specification limit per vaccine dose, as set by the European Medicines Agency (EMA) for this vaccine, by at least 25-fold and the manufacturer's batch-release data in some of the lots by several hundred-fold. In contrast, three tested lots of the Ad26.COV2.S vaccine contained only very low amounts of HCPs. As shown for Ad26.COV2.S production of clinical grade adenovirus vaccines of high purity is feasible at an industrial scale. Correspondingly, purification procedures of the ChAdOx1 nCov-19 vaccine should be modified to remove protein impurities as good as possible. Our data also indicate that standard quality assays, as they are used in the manufacturing of proteins, have to be adapted for vectored vaccines.

Indexed as

COVID-19SARS-CoV-2Ad26COVS1ChAdOx1 nCoV-19HumansAd26COVS1ChAdOx1 nCoV-19adenovirushost cell proteinsinfectious diseasemicrobiologyprocess-related impuritiesSARS-CoV-2vaccineviruses

Identifiers

PMID35781137
PMCPMC9313527
OpenAlexW4283796775

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.