Evidence map›Paper›PMID 35465982›Full record

ArticleVaccine2022

Covax-19/Spikogen® vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters.

Lei Li, Yoshikazu Honda-Okubo, Jeremy Baldwin, Richard Bowen, Helle Bielefeldt-Ohmann, Nikolai Petrovsky

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

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.9field-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 map

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
NCT05542862 phase3completednot on this map

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

24 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
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  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
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  19. Big knowledge visualization of the COVID-19 CIDO ontology evolution.BMC medical informatics and decision making · 2023
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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 4 institutions in 2 countries.

Lei LiVaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, Australia.
Yoshikazu Honda-OkuboVaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, Australia.
Jeremy BaldwinVaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia.
Richard BowenDepartment of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA.
Helle Bielefeldt-OhmannSchool of Chemistry & Molecular Biosciences, The University of Queensland, St. Lucia, Qld 4072, Australia.
Nikolai PetrovskyVaxine Pty Ltd, Bedford Park, Adelaide 5042, Australia; College of Medicine and Public Health, Flinders University, Adelaide 5042, Australia. Electronic address: nikolai.petrovsky@flinders.edu.au.
Flinders University · AUVaxine (Australia) · AUColorado State University · USUniversity of Queensland · AU

Funding

NIAID NIH HHS HHSN272201400053CNIAID NIH HHS HHSN272201800024CNIAID NIH HHS HHSN272201800044C
6 · The paper itself

Abstract

COVID-19 presents an ongoing global health crisis. Protein-based COVID-19 vaccines that are well-tolerated, safe, highly-protective and convenient to manufacture remain of major interest. We therefore sought to compare the immunogenicity and protective efficacy of a number of recombinant SARS-CoV-2 spike protein candidates expressed in insect cells. By comparison to a full length (FL) spike protein detergent-extracted nanoparticle antigen, the soluble secreted spike protein extracellular domain (ECD) generated higher protein yields per liter of culture and when formulated with either Alum-CpG55.2 or Advax-CpG55.2 combination adjuvants elicited robust antigen-specific humoral and cellular immunity in mice. In hamsters, the spike ECD when formulated with either adjuvant induced high serum neutralizing antibody titers even after a single dose. When challenged with the homologous SARS-CoV-2 virus, hamsters immunized with the adjuvanted spike ECD exhibited reduced viral load in day 1-3 oropharyngeal swabs and day 3 nasal turbinate tissue and had no recoverable infectious virus in day 3 lung tissue. The reduction in lung viral load correlated with less weight loss and lower lung pathology scores. The formulations of spike ECD with Alum-CpG55.2 or Advax-CpG55.2 were protective even after just a single dose, although the 2-dose regimen performed better overall and required only half the total amount of antigen. Pre-challenge serum neutralizing antibody levels showed a strong correlation with lung protection, with a weaker correlation seen with nasal or oropharyngeal protection. This suggests that serum neutralizing antibody levels may correlate more closely with systemic, rather than mucosal, protection. The spike protein ECD with Advax-CpG55.2 formulation (Covax-19® vaccine) was selected for human clinical development.

Indexed as

COVID-19Adjuvants, ImmunologicAnimalsAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesCricetinaeHumansInulinMiceSARS-CoV-2Spike Glycoprotein, CoronavirusVaccines, SubunitAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccinesdelta inulinInulinSARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccineSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, SubunitAdjuvantAdvaxCoronavirusCOVID-19PandemicSARS-Cov-2Vaccine

Identifiers

PMID35465982
PMCPMC9013662
OpenAlexW4224058578

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.