Evidence map›Paper›PMID 37620203›Full record

ArticleVaccine2023

Formulation development and comparability studies with an aluminum-salt adjuvanted SARS-CoV-2 spike ferritin nanoparticle vaccine antigen produced from two different cell lines.

Ozan S Kumru, Mrinmoy Sanyal, Natalia Friedland, John M Hickey, Richa Joshi, Payton Weidenbacher, Jonathan Do, Ya-Chen Cheng, Peter S Kim, Sangeeta B Joshi and 1 more

Open access · hybridAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 34% 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

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. International journal of nanomedicine · 2025
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Ozan S KumruDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Mrinmoy SanyalDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA.
Natalia FriedlandDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA.
John M HickeyDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Richa JoshiDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Payton WeidenbacherDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA.
Jonathan DoDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA.
Ya-Chen ChengDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA.
Peter S KimDepartment of Biochemistry, Stanford University School of Medicine, Palo Alto, CA 94305, USA; Sarafan ChEM-H, Stanford University, Stanford, CA 94305, USA; Chan Zuckerberg Biohub, San Francisco, CA 94158, USA.
Sangeeta B JoshiDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
David B VolkinDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA. Electronic address: volkin@ku.edu.
Stanford University · USUniversity of Kansas · USChan Zuckerberg Initiative (United States) · US

Funding

Creating high-resolution, epitope-focused vaccinesDP1AI158125 · NIAID · STANFORD UNIVERSITY · PI KIM, PETER S · 2020 to 2024
$5.9M
NIAID NIH HHS DP1 AI158125
6 · The paper itself

Abstract

The development of safe and effective second-generation COVID-19 vaccines to improve affordability and storage stability requirements remains a high priority to expand global coverage. In this report, we describe formulation development and comparability studies with a self-assembled SARS-CoV-2 spike ferritin nanoparticle vaccine antigen (called DCFHP), when produced in two different cell lines and formulated with an aluminum-salt adjuvant (Alhydrogel, AH). Varying levels of phosphate buffer altered the extent and strength of antigen-adjuvant interactions, and these formulations were evaluated for their (1) in vivo performance in mice and (2) in vitro stability profiles. Unadjuvanted DCFHP produced minimal immune responses while AH-adjuvanted formulations elicited greatly enhanced pseudovirus neutralization titers independent of ∼100%, ∼40% or ∼10% of the DCFHP antigen adsorbed to AH. These formulations differed, however, in their in vitro stability properties as determined by biophysical studies and a competitive ELISA for measuring ACE2 receptor binding of AH-bound antigen. Interestingly, after one month of 4°C storage, small increases in antigenicity with concomitant decreases in the ability to desorb the antigen from the AH were observed. Finally, we performed a comparability assessment of DCFHP antigen produced in Expi293 and CHO cells, which displayed expected differences in their N-linked oligosaccharide profiles. Despite consisting of different DCFHP glycoforms, these two preparations were highly similar in their key quality attributes including molecular size, structural integrity, conformational stability, binding to ACE2 receptor and mouse immunogenicity profiles. Taken together, these studies support future preclinical and clinical development of an AH-adjuvanted DCFHP vaccine candidate produced in CHO cells.

Indexed as

Adjuvants, ImmunologicCOVID-19COVID-19 VaccinesFerritinsNanoparticlesSARS-CoV-2Spike Glycoprotein, CoronavirusAluminum HydroxideAnimalsAntibodies, NeutralizingAntibodies, ViralCell LineCHO CellsCricetulusFemaleHumansAdjuvants, ImmunologicAluminum HydroxideAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesFerritinsNanovaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2AdjuvantsAlhydrogelComparabilityFerritinFormulationNanoparticle vaccineSARS-CoV-2 spike proteinStability

Identifiers

PMID37620203
PMCPMC11181998
OpenAlexW4386070665

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.