Evidence map›Paper›PMID 32325038›Full record

ArticleThe Lancet. Infectious diseases2020

Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.

Pedro M Folegatti, Mustapha Bittaye, Amy Flaxman, Fernando Ramos Lopez, Duncan Bellamy, Alexandra Kupke, Catherine Mair, Rebecca Makinson, Jonathan Sheridan, Cornelius Rohde and 20 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04516746 (A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19), which is not on this map. Cited by 149 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 3% 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.

NCT04516746 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled32,450ConditionsCOVID-19, SARS-CoV-2ArmsAZD1222, Placebo
3 · Its place in the literature

Who cites it

149 citing papers in PubMed, 1 synthesis or guideline pooled it, 236 citations in OpenAlex.

  1. Pooled it
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  8. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
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  15. [Vaccinations for emerging and re-emerging viral diseases].Innere Medizin (Heidelberg, Germany) · 2024
    Article
  16. Review
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89 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 5 institutions in 3 countries.

Pedro M FolegattiThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Mustapha BittayeThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Amy FlaxmanThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Fernando Ramos LopezThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Duncan BellamyThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Alexandra KupkeInstitute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.
Catherine MairThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rebecca MakinsonThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Jonathan SheridanThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Cornelius RohdeInstitute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.
Sandro HalweInstitute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.
Yuji JeongInternational Vaccine Institute, Science Unit, Seoul, South Korea.
Young-Shin ParkInternational Vaccine Institute, Science Unit, Seoul, South Korea.
Jae-Ouk KimInternational Vaccine Institute, Science Unit, Seoul, South Korea.
Manki SongInternational Vaccine Institute, Science Unit, Seoul, South Korea.
Amy BoydThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Nguyen TranThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Daniel SilmanThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Ian PoultonThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Mehreen DatooThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Julia MarshallThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Yrene ThemistocleousThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Alison LawrieThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rachel RobertsThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Eleanor BerrieThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Stephan BeckerInstitute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.
Teresa LambeThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Adrian HillThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Katie EwerThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Sarah GilbertThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.
University of Oxford · GBJenner Institute · GBInternational Vaccine Institute · KRPhilipps University of Marburg · DEGerman Center for Infection Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans.

methodsThis dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10

findingsBetween March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10

interpretationChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials.

fundingUK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.

Indexed as

Dose-Response Relationship, ImmunologicImmunogenicity, VaccineAdultAntibodies, NeutralizingAntibodies, ViralCoronavirus InfectionsEnzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedMiddle East Respiratory Syndrome CoronavirusUnited KingdomVaccines, DNAViral VaccinesYoung AdultAntibodies, NeutralizingAntibodies, ViralMiddle East respiratory syndrome vaccineVaccines, DNAViral Vaccines

Identifiers

PMID32325038
PMCPMC7172901
OpenAlexW3017390697

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.