Evidence map›Paper›PMID 33392485›Full record

ArticleEClinicalMedicine2021

Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial.

Pablo Tebas, ShuPing Yang, Jean D Boyer, Emma L Reuschel, Ami Patel, Aaron Christensen-Quick, Viviane M Andrade, Matthew P Morrow, Kimberly Kraynyak, Joseph Agnes and 28 more

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

Article in EClinicalMedicine, 2021. 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 168 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 6 pooled it
5.9field-weighted citation impact, top 3% 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.

NCT04336410 phase1completednot on this map

Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

TypeinterventionalSponsorInovio PharmaceuticalsRan2020 to 2022Enrolled120ConditionsCoronavirus InfectionArmsINO-4800, CELLECTRA® 2000
NCT05102643 phase1unknown statusnot on this map

A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults

TypeinterventionalSponsorThe University of Hong KongRan2021 to 2022Enrolled30ConditionsCovid19ArmsSARS-CoV-2 DNA Vaccine, Matching placebo
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 6 syntheses or guidelines pooled it, 278 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Observational
  17. Article
  18. Article
  19. Review
  20. Review

108 more citing papers are in PubMed but not listed here.

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

38 authors at 5 institutions in 2 countries.

Pablo TebasHospital of the University of Pennsylvania, Philadelphia, PA, USA.
ShuPing YangInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Jean D BoyerInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Emma L ReuschelVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Ami PatelVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Aaron Christensen-QuickInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Viviane M AndradeInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Matthew P MorrowInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Kimberly KraynyakInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Joseph AgnesInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Mansi PurwarVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Albert SylvesterInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Jan PawlickiInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Elisabeth GillespieInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Igor MaricicInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Faraz I ZaidiVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Kevin Y KimVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Yaya DiaVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Drew FraseVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Patrick PezzoliInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Katherine SchultheisInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Trevor R F SmithInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Stephanie J RamosInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Trevor McMullanInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Karen ButtigiegPublic Health England, Porton, United Kingdom.
Miles W CarrollPublic Health England, Porton, United Kingdom.
John ErvinAlliance for Multispecialty Research, Kansas City, MO 64114-4866.
Malissa C DiehlInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Elliott BlackwoodInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Mammen P MammenInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Jessica LeeInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Michael J DallasInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Ami Shah BrownInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Jacqueline E SheaInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
J Joseph KimInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
David B WeinerVaccine and Immunotherapy Center, Wistar Institute, Philadelphia, PA 19104, USA.
Kate E BroderickInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Laurent M HumeauInovio Pharmaceuticals, Plymouth Meeting, PA 19462, USA.
Inovio Pharmaceuticals (United States) · USThe Wistar Institute · USPublic Health England · GBAlliance for Multispecialty Research (United States) · USHospital of the University of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA vaccine against SARS-CoV-2 is of high urgency. Here the safety and immunogenicity induced by a DNA vaccine (INO-4800) targeting the full length spike antigen of SARS-CoV-2 are described.

methodsINO-4800 was evaluated in two groups of 20 participants, receiving either 1.0 mg or 2.0 mg of vaccine intradermally followed by CELLECTRA® EP at 0 and 4 weeks. Thirty-nine subjects completed both doses; one subject in the 2.0 mg group discontinued trial participation prior to receiving the second dose. ClinicalTrials.gov identifier: NCT04336410.

findingsThe median age was 34.5, 55% (22/40) were men and 82.5% (33/40) white. Through week 8, only 6 related Grade 1 adverse events in 5 subjects were observed. None of these increased in frequency with the second administration. No serious adverse events were reported. All 38 subjects evaluable for immunogenicity had cellular and/or humoral immune responses following the second dose of INO-4800. By week 6, 95% (36/38) of the participants seroconverted based on their responses by generating binding (ELISA) and/or neutralizing antibodies (PRNT IC

interpretationINO-4800 demonstrated excellent safety and tolerability and was immunogenic in 100% (38/38) of the vaccinated subjects by eliciting either or both humoral or cellular immune responses.

fundingCoalition for Epidemic Preparedness Innovations (CEPI).

Indexed as

COVID-19DNA vaccineINO-4800Phase 1SARS-CoV-2

Identifiers

PMID33392485
PMCPMC7759123
OpenAlexW3115068672

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.