Evidence map›Paper›PMID 39397784›Full record

ArticleHuman vaccines & immunotherapeutics2024

A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity.

Ute Klinkardt, Mirjam Schunk, John Ervin, Christoph Schindler, Danny Sugimoto, Bruce Rankin, Ralf Amann, Martina Monti, Anna Kutschenko, Carsten Schumacher and 6 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05367843 (A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT05367843 phase1terminatednot on this map

A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)

TypeinterventionalSponsorSperansa TherapeuticsRan2022 to 2023Enrolled103ConditionsSARS-CoV-2 InfectionArmsPRIME-2-CoV_Beta
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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.

Ute KlinkardtSperansa Therapeutics, TowerOne (Spaces), Frankfurt am Main, Germany.
Mirjam SchunkInstitute of Infectious Diseases and Tropical Medicine, LMU University Hospital, Munich, Germany.
John ErvinAMR - Center for Pharmaceutical Research, Kansas City, MO, USA.
Christoph SchindlerMedizinische Hochschule Hannover (MHH), Center for Clinical Trials (ZKS) - Early Clinical Trial Unit (ECTU), Hanover, Germany.
Danny SugimotoCedar Crosse Research Cente, Chicago, IL, USA.
Bruce RankinAccel Research Sites (ARS) - Corporate Office, DeLand, FL, USA.
Ralf AmannDepartment of Immunology, Institute for Cell Biology, University of Tübingen, Tübingen, Germany.
Martina MontiVisMederi Srl, Siena, Italy.
Anna KutschenkoMedizinische Hochschule Hannover (MHH), Center for Clinical Trials (ZKS) - Early Clinical Trial Unit (ECTU), Hanover, Germany.
Carsten SchumacherMedizinische Hochschule Hannover (MHH), Center for Clinical Trials (ZKS) - Early Clinical Trial Unit (ECTU), Hanover, Germany.
Kristina HuberInstitute of Infectious Diseases and Tropical Medicine, LMU University Hospital, Munich, Germany.
Andreas ZederInstitute of Infectious Diseases and Tropical Medicine, LMU University Hospital, Munich, Germany.
Nelli HeikkilaCenter of Vaccinology, Department of Pathology and Immunology, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Arnaud M DidierlaurentCenter of Vaccinology, Department of Pathology and Immunology, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Sylvia E SchwarzSperansa Therapeutics, TowerOne (Spaces), Frankfurt am Main, Germany.
Madiha DerouaziSperansa Therapeutics, TowerOne (Spaces), Frankfurt am Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Next-generation COVID-19 vaccines are being developed to expand the breadth of coverage against existing and future variants and to extend the duration of protection. Prime-2-CoV_Beta is an orf virus (ORFV) based multi-antigen COVID-19 vaccine that co-expresses Spike (S) and Nucleocapsid (N) antigens. The safety and immunogenicity of Prime-2-CoV_Beta is investigated in a phase 1 first-in-human (FIH) dose-finding trial (ORFEUS study, ClinicalTrials.gov: NCT05367843). Participants of two age groups (18-55 and 65-85 years) who previously completed at least two doses of mRNA vaccines were enrolled and sequentially assigned to different dose groups to receive one intramuscular dose of 3 × 10

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-2AdolescentAdultAgedAged, 80 and overCD8-Positive T-LymphocytesFemaleGenetic VectorsHumansImmunogenicity, VaccineMaleAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirusbooster vaccineCOVID-19first-in-human trialimmunogenicityORF virus-vectorsafetySARS-CoV-2 variants

Identifiers

PMID39397784
PMCPMC11485980

What OpenQuestion holds

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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.