Evidence map›Paper›PMID 35043093›Full record

ArticleEClinicalMedicine2022

Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial.

Katrina M Pollock, Hannah M Cheeseman, Alexander J Szubert, Vincenzo Libri, Marta Boffito, David Owen, Henry Bern, Jessica O'Hara, Leon R McFarlane, Nana-Marie Lemm and 21 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 104 papers.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed
14.9field-weighted citation impact, top 1% 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

104 citing papers in PubMed, 152 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. A self-amplifying mRNA SARS-CoV-2 vaccine candidate induces safe and robust protective immunity in preclinical models.Molecular therapy : the journal of the American Society of Gene Therapy · 2022
    Trial
  5. Article
  6. Review
  7. Towards mRNA therapeutics 2.0.Nature reviews. Drug discovery · 2026
    Review
  8. iScience · 2026
    Article
  9. Enhanced efficacy of a next-generation EEEV self-replicating RNA platform for combination cancer immunotherapies.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  10. An RNA-to-RNA pipeline for rapid antiviral antibody development.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  11. mRNA Vaccines for Influenza: Hope for a Universal Vaccine?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  18. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  19. Article
  20. Article

44 more citing papers are in PubMed but not listed here.

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

31 authors at 8 institutions in 1 country.

Katrina M PollockDepartment of Infectious Disease, Imperial College London.
Hannah M CheesemanDepartment of Infectious Disease, Imperial College London.
Alexander J SzubertMRC Clinical Trials Unit at UCL, London, UK.
Vincenzo LibriNIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK.
Marta BoffitoDepartment of Infectious Disease, Imperial College London.
David OwenNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Henry BernMRC Clinical Trials Unit at UCL, London, UK.
Jessica O'HaraDepartment of Infectious Disease, Imperial College London.
Leon R McFarlaneDepartment of Infectious Disease, Imperial College London.
Nana-Marie LemmDepartment of Infectious Disease, Imperial College London.
Paul F McKayDepartment of Infectious Disease, Imperial College London.
Tommy RamplingNIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK.
Yee Ting N YimNIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK.
Ana MilinkovicChelsea & Westminster Hospital, London.
Cherry KingsleyDepartment of Infectious Disease, Imperial College London.
Tom ColeNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Susanne FagerbrinkNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Marites AbanNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Maniola TanakaNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Savviz MehdipourNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Alexander RobbinsNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
William BuddNIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.
Saul N FaustNIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
Hana HassaninSurrey Clinical Research Facility, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.
Catherine A CosgroveCentre for Infection, St George's, University of London, London, United Kingdom.
Alan WinstonDepartment of Infectious Disease, Imperial College London.
Sarah FidlerDepartment of Infectious Disease, Imperial College London.
David T DunnMRC Clinical Trials Unit at UCL, London, UK.
Sheena McCormackMRC Clinical Trials Unit at UCL, London, UK.
Robin J ShattockDepartment of Infectious Disease, Imperial College London.
COVAC1 study Group
Imperial College London · GBNIHR Imperial Biomedical Research Centre · GBMRC Clinical Trials Unit at UCL · GBUCL Biomedical Research Centre · GBChelsea and Westminster Hospital · GBSt George's, University of London · GBUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Surrey · GB

Funding

Medical Research Council MC_PC_19076Medical Research Council MC_UU_00004/04Medical Research Council MR/N008219/1Medical Research Council MR/T031891/1
6 · The paper itself

Abstract

backgroundLipid nanoparticle (LNP) encapsulated self-amplifying RNA (saRNA) is a novel technology formulated as a low dose vaccine against COVID-19.

methodsA phase I first-in-human dose-ranging trial of a saRNA COVID-19 vaccine candidate LNP-nCoVsaRNA, was conducted at Imperial Clinical Research Facility, and participating centres in London, UK, between 19

findings192 healthy individuals with no history or serological evidence of COVID-19, aged 18-45 years were enrolled. The vaccine was well tolerated with no serious adverse events related to vaccination. Seroconversion at week six whether measured by ELISA or immunoblot was related to dose (both p<0.001), ranging from 8% (3/39; 0.1μg) to 61% (14/23; 10.0μg) in ELISA and 46% (18/39; 0.3μg) to 87% (20/23; 5.0μg and 10.0μg) in a post-hoc immunoblot assay. Geometric mean (GM) anti-S IgG concentrations ranged from 74 (95% CI, 45-119) at 0.1μg to 1023 (468-2236) ng/mL at 5.0μg (p<0.001) and was not higher at 10.0μg. Neutralisation of SARS-CoV-2 by participant sera was measurable in 15% (6/39; 0.1μg) to 48% (11/23; 5.0μg) depending on dose level received.

interpretationEncapsulated saRNA is safe for clinical development, is immunogenic at low dose levels but failed to induce 100% seroconversion. Modifications to optimise humoral responses are required to realise its potential as an effective vaccine against SARS-CoV-2.

fundingThis study was co-funded by grants and gifts from the Medical Research Council UKRI (MC_PC_19076), and the National Institute Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, Restore the Earth.

Indexed as

AEs, adverse eventsGOI, gene of InterestLNP, lipid nanoparticleNSP, non-structural proteinsaRNA, self-amplifying RNAVEEV, Venezuelan equine encephalitis virus

Identifiers

PMID35043093
PMCPMC8759012
OpenAlexW4220898781

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.