Evidence map›Paper›PMID 39460266›Full record

ArticleVaccines2024

Safety and Immunogenicity Study of a Bivalent Vaccine for Combined Prophylaxis of COVID-19 and Influenza in Non-Human Primates.

Ekaterina Stepanova, Irina Isakova-Sivak, Victoria Matyushenko, Daria Mezhenskaya, Igor Kudryavtsev, Arina Kostromitina, Anna Chistiakova, Alexandra Rak, Ekaterina Bazhenova, Polina Prokopenko and 6 more

Abstract read
In one paragraph

Article in Vaccines, 2024. 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
–field-weighted citation impact
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.

  1. Article
  2. Review
  3. Review
  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

16 authors.

Ekaterina StepanovaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0002-8670-8645
Irina Isakova-SivakInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Victoria MatyushenkoInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Daria MezhenskayaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0001-6922-7682
Igor KudryavtsevInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Arina KostromitinaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0001-5432-0171
Anna ChistiakovaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0001-9541-5636
Alexandra RakInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Ekaterina BazhenovaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0003-3280-556X
Polina ProkopenkoInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Tatiana KotominaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.ORCID 0000-0001-9999-089X
Svetlana DoninaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Vlada NovitskayaInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.
Konstantin SivakSmorodintsev Research Institute of Influenza, Saint-Petersburg 197376, Russia.ORCID 0000-0003-4064-5033
Dzhina Karal-OglyCenter of Preclinical Research, Research Institute of Medical Primatology, Sochi 354376, Russia.
Larisa RudenkoInstitute of Experimental Medicine, Saint-Petersburg 197022, Russia.

Funding

Russian Science Foundation 21-75-30003
6 · The paper itself

Abstract

backgroundInfluenza and SARS-CoV-2 viruses are two highly variable pathogens. We have developed a candidate bivalent live vaccine based on the strain of licensed A/Leningrad/17-based cold-adapted live attenuated influenza vaccine (LAIV) of H3N2 subtype, which expressed SARS-CoV-2 immunogenic T-cell epitopes. A cassette encoding fragments of S and N proteins of SARS-CoV-2 was inserted into the influenza NA gene using the P2A autocleavage site. In this study, we present the results of preclinical evaluation of the developed bivalent vaccine in a non-human primate model.

methodsRhesus macaques (

resultsThere was no toxic effect of the immunizations on the hematological and coagulation hemostasis of animals. No difference in the dynamics of the average weight and thermometry results were found between the groups of animals. Both LAIV and LAIV/CoV-2 variants poorly replicated in the upper respiratory tract of rhesus macaques. Nevertheless, despite this low level of virus shedding, influenza-specific serum IgG responses were detected in the group of monkeys immunized with the LAIV/CoV-2 bivalent but not in the LAIV group. Furthermore, T-cell responses to both influenza and SARS-CoV-2 viruses were detected in the LAIV/CoV-2 vaccine group only. The animals were generally resistant to SARS-CoV-2 challenge, with minimal virus shedding in the placebo and LAIV groups. Histopathological changes in vaccinated animals were decreased compared to the PBS group, suggesting a protective effect of the chimeric vaccine candidate.

conclusionsThe candidate bivalent vaccine was safe and immunogenic for non-human primates and warrants its further evaluation in clinical trials.

Indexed as

bivalent vaccineinfluenzanon-human primatespreclinical studyrhesus monkeysSARS-CoV-2virus-vectored vaccine

Identifiers

PMID39460266
PMCPMC11511058

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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.