Evidence map›Paper›PMID 36016181›Full record

ArticleVaccines2022

SARS-CoV-2 Subunit Virus-like Vaccine Demonstrates High Safety Profile and Protective Efficacy: Preclinical Study.

Anna V Vakhrusheva, Aleksandr V Kudriavtsev, Nickolay A Kryuchkov, Roman V Deev, Maria E Frolova, Konstantin A Blagodatskikh, Milana Djonovic, Andrey A Nedorubov, Elena Odintsova, Aleksandr V Ivanov and 4 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Vaccine adjuvants for infectious disease in the clinic.Bioengineering & translational medicine · 2024
    Review
  3. Article
  4. 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

14 authors at 8 institutions in 1 country.

Anna V VakhrushevaBetuvax LLC, 121096 Moscow, Russia.ORCID 0000-0001-7948-1254
Aleksandr V KudriavtsevBetuvax LLC, 121096 Moscow, Russia.ORCID 0000-0002-3918-5618
Nickolay A KryuchkovClinical Excellence Group LLC, 127051 Moscow, Russia.ORCID 0000-0002-8960-776X
Roman V DeevDepartment of Pathological Anatomy, I.I. Mechnikov North-Western State Medical University, 195067 Saint Petersburg, Russia.ORCID 0000-0001-8389-3841
Maria E FrolovaPJSC Human Stem Cells Institute, 129110 Moscow, Russia.
Konstantin A BlagodatskikhCenter of Genetics and Reproductive Medicine "Genetico", 119333 Moscow, Russia.ORCID 0000-0002-8732-0300
Milana DjonovicBetuvax LLC, 121096 Moscow, Russia.ORCID 0000-0003-3813-3290
Andrey A NedorubovCenter for Preclinical Studies, Sechenov First Moscow State Medical University, 119435 Moscow, Russia.ORCID 0000-0002-5915-7999
Elena OdintsovaCenter for Preclinical Studies, Sechenov First Moscow State Medical University, 119435 Moscow, Russia.ORCID 0000-0002-4098-5559
Aleksandr V IvanovBiotechnology Developments LLC, 119285 Moscow, Russia.ORCID 0000-0002-7608-1914
Ekaterina A Romanovskaya-RomankoDepartment of Vaccinology, Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia.ORCID 0000-0001-7560-398X
Marina A StukovaDepartment of Vaccinology, Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia.ORCID 0000-0002-2127-3820
Artur A IsaevPJSC Human Stem Cells Institute, 129110 Moscow, Russia.ORCID 0000-0001-5848-5117
Igor V KrasilnikovBiotechnology Developments LLC, 119285 Moscow, Russia.ORCID 0000-0002-5048-7828
Ministry of Health of the Russian Federation · RUHuman Stem Cells Institute PJSC (Russia) · RULomonosov Moscow State University · RUSechenov University · RUAll-Russian Scientific Research Institute of Food Biotechnology · RUMoscow Clinical Scientific Center · RUNorth-Western State Medical University named after I.I. Mechnikov · RUResearch Centre for Medical Genetics · RU

Funding

Moscow Seed FundPJSC "Human Stem Cells Institute"
6 · The paper itself

Abstract

Public health threat coming from a rapidly developing COVID-19 pandemic calls for developing safe and effective vaccines with innovative designs. This paper presents preclinical trial results of "Betuvax-CoV-2", a vaccine developed as a subunit vaccine containing a recombinant RBD-Fc fusion protein and betulin-based spherical virus-like nanoparticles as an adjuvant ("Betuspheres"). The study aimed to demonstrate vaccine safety in mice, rats, and Chinchilla rabbits through acute, subchronic, and reproductive toxicity studies. Along with safety, the vaccine demonstrated protective efficacy through SARS-CoV-2-neutralizing antibody production in mice, rats, hamsters, rabbits, and primates (rhesus macaque), and lung damage and infection protection in hamsters and rhesus macaque model. Eventually, "Betuvax-CoV-2" was proved to confer superior efficacy and protection against the SARS-CoV-2 in preclinical studies. Based on the above results, the vaccine was enabled to enter clinical trials that are currently underway.

Indexed as

betulinCOVID-19nanoparticle vaccineRBD-based vaccinerecombinant vaccineSARS-CoV-2

Identifiers

PMID36016181
PMCPMC9412395
OpenAlexW4291123780

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.