Evidence map›Paper›PMID 34420786›Full record

ArticleVaccine2021

Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection.

Lei Li, Yoshikazu Honda-Okubo, Ying Huang, Hyesun Jang, Michael A Carlock, Jeremy Baldwin, Sakshi Piplani, Anne G Bebin-Blackwell, David Forgacs, Kaori Sakamoto and 7 more

3 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in Vaccine, 2021. 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 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing 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.

NCT05148871 phase2 / phase3active not recruitingnot on this mapstarted 2022, after this paper: background citation

A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)

TypeinterventionalSponsorVaxine Pty LtdRan2022 to 2024Enrolled200ConditionsCOVID-19ArmsSpikogen/Covax-19
NCT05279456 phase3completednot on this mapstarted 2022, after this paper: background citation

A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)

TypeinterventionalSponsorVaxine Pty LtdRan2022 to 2023Enrolled39ConditionsCOVID-19ArmsAdvax-CpG55.2 adjuvanted recombinant spike protein
NCT05542862 phase3completednot on this mapstarted 2022, after this paper: background citation

Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine

TypeinterventionalSponsorVaxine Pty LtdRan2022 to 2025Enrolled81ConditionsCOVID-19ArmsSpikoGen vaccine
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 69 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Trial
  5. Safety and immunogenicity of SpikoGen®, an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

17 authors at 4 institutions in 2 countries.

Lei LiVaxine Pty Ltd., Bedford Park, Adelaide 5042, SA, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.
Yoshikazu Honda-OkuboVaxine Pty Ltd., Bedford Park, Adelaide 5042, SA, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.
Ying HuangCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
Hyesun JangCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
Michael A CarlockCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
Jeremy BaldwinVaxine Pty Ltd., Bedford Park, Adelaide 5042, SA, Australia.
Sakshi PiplaniVaxine Pty Ltd., Bedford Park, Adelaide 5042, SA, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.
Anne G Bebin-BlackwellCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
David ForgacsCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
Kaori SakamotoDepartment of Pathology, University of Georgia, Athens, GA, USA.
Alberto StellaCentre for Virus Research, Westmead Millennium Institute, Westmead Hospital and University of Sydney, Sydney 2145, NSW, Australia.
Stuart TurvilleCentre for Virus Research, Westmead Millennium Institute, Westmead Hospital and University of Sydney, Sydney 2145, NSW, Australia.
Tim ChatawayCollege of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.
Alex ColellaCollege of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.
Jamie TriccasSchool of Medical Sciences and Marie Bashir Institute, University of Sydney, Sydney, NSW 2006, Australia.
Ted M RossCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA; Department of Infectious Diseases, University of Georgia, Athens, GA, USA.
Nikolai PetrovskyVaxine Pty Ltd., Bedford Park, Adelaide 5042, SA, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia. Electronic address: nikolai.petrovsky@flinders.edu.au.
University of Georgia · USFlinders University · AUThe University of Sydney · AUVaxine (Australia) · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of a safe and effective vaccine is a key requirement to overcoming the COVID-19 pandemic. Recombinant proteins represent the most reliable and safe vaccine approach but generally require a suitable adjuvant for robust and durable immunity. We used the SARS-CoV-2 genomic sequence and in silico structural modelling to design a recombinant spike protein vaccine (Covax-19™). A synthetic gene encoding the spike extracellular domain (ECD) was inserted into a baculovirus backbone to express the protein in insect cell cultures. The spike ECD was formulated with Advax-SM adjuvant and first tested for immunogenicity in C57BL/6 and BALB/c mice. Covax-19 vaccine induced high spike protein binding antibody levels that neutralised the original lineage B.1.319 virus from which the vaccine spike protein was derived, as well as the variant B.1.1.7 lineage virus. Covax-19 vaccine also induced a high frequency of spike-specific CD4 + and CD8 + memory T-cells with a dominant Th1 phenotype associated with the ability to kill spike-labelled target cells in vivo. Ferrets immunised with Covax-19 vaccine intramuscularly twice 2 weeks apart made spike receptor binding domain (RBD) IgG and were protected against an intranasal challenge with SARS-CoV-2 virus given two weeks after the last immunisation. Notably, ferrets that received the two higher doses of Covax-19 vaccine had no detectable virus in their lungs or in nasal washes at day 3 post-challenge, suggesting that in addition to lung protection, Covax-19 vaccine may have the potential to reduce virus transmission. This data supports advancement of Covax-19 vaccine into human clinical trials.

Indexed as

COVID-19Spike Glycoprotein, CoronavirusAnimalsAntibodies, ViralFerretsHumansImmunizationInulinMiceMice, Inbred BALB CMice, Inbred C57BLPandemicsSARS-CoV-2Antibodies, Viraldelta inulinInulinSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID34420786
PMCPMC8328570
OpenAlexW3187116858

What OpenQuestion holds

Textmetadata
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.