Evidence map›Paper›PMID 36534786›Full record

ArticleCancer prevention research (Philadelphia, Pa.)2023

Phase I Trial of a Therapeutic DNA Vaccine for Preventing Hepatocellular Carcinoma from Chronic Hepatitis C Virus (HCV) Infection.

Jeffrey M Jacobson, David Zahrieh, Carrie A Strand, Marcia Cruz-Correa, Surakit Pungpapong, Lewis R Roberts, Sumithra J Mandrekar, Luz Maria Rodriguez, Jean Boyer, Idania Marrero and 11 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer prevention research (Philadelphia, Pa.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

11 citing papers in PubMed, 14 citations in OpenAlex.

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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

21 authors at 9 institutions in 3 countries.

Jeffrey M JacobsonDepartment of Medicine, Case Western Reserve University, Cleveland, Ohio.ORCID 0000-0003-0725-249X
David ZahriehMayo Clinic, Rochester, Minnesota.ORCID 0000-0002-5106-1730
Carrie A StrandMayo Clinic, Rochester, Minnesota.ORCID 0000-0001-7820-6138
Marcia Cruz-CorreaUniversity of Puerto Rico, San Juan, Puerto Rico.ORCID 0000-0001-8147-7457
Surakit PungpapongMayo Clinic, Jacksonville, Florida.ORCID 0000-0001-6455-959X
Lewis R RobertsMayo Clinic, Rochester, Minnesota.ORCID 0000-0001-7885-8574
Sumithra J MandrekarMayo Clinic, Rochester, Minnesota.ORCID 0000-0002-7658-1134
Luz Maria RodriguezNational Cancer Institute, Division of Cancer Prevention, Rockville, Maryland.ORCID 0000-0002-2119-6124
Jean BoyerInovio Pharmaceuticals, San Diego, California.ORCID 0000-0001-8699-0532
Idania MarreroInovio Pharmaceuticals, San Diego, California.ORCID 0000-0002-5793-706X
Kimberly A KraynyakInovio Pharmaceuticals, Inc., Plymouth Meeting, Pennsylvania.ORCID 0000-0001-9233-8858
Matthew P MorrowInovio Pharmaceuticals, Inc., Plymouth Meeting, Pennsylvania.ORCID 0000-0003-0258-6095
Albert J SylvesterInovio Pharmaceuticals, Inc., Plymouth Meeting, Pennsylvania.ORCID 0000-0002-4087-9596
Jan M PawlickiInovio Pharmaceuticals, Inc., Plymouth Meeting, Pennsylvania.ORCID 0000-0002-2000-512X
Elisabeth GillespieInovio Pharmaceuticals, Inc., Plymouth Meeting, Pennsylvania.ORCID 0000-0001-7552-5440
Eduardo BarrancoInovio Pharmaceuticals, San Diego, California.ORCID 0000-0003-4413-8741
Ellen RichmondNational Cancer Institute, Division of Cancer Prevention, Rockville, Maryland.ORCID 0000-0002-5855-5047
Asad UmarNational Cancer Institute, Division of Cancer Prevention, Rockville, Maryland.ORCID 0000-0002-6239-8494
David B WeinerWistar Institute, Philadelphia, Pennsylvania.ORCID 0000-0002-2232-8512
Paul J LimburgMayo Clinic, Rochester, Minnesota.ORCID 0000-0002-2428-5675
Cancer Prevention Network
Inovio Pharmaceuticals (United States) · USMayo Clinic · USPlex Pharmaceuticals (United States) · USNational Cancer Institute · MYCase Western Reserve University · USMayo Clinic in Florida · USThe Wistar Institute · USUniversity of Puerto Rico System · PRWalter Reed National Military Medical Center · US

Funding

Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Joseph M Salvino · 1985 to 2026
$75.9M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS -261035000N01CN035000 · CN · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LIMBURG, PAUL J · 1985 to 2006
–
NCI NIH HHS HHSN261201000042INCI NIH HHS HHSN261201200042CNCI NIH HHS N01 CN035000NCI NIH HHS P30 CA010815
6 · The paper itself

Abstract

Chronic hepatitis C can lead to cirrhosis and hepatocellular carcinoma. We studied the safety and immunogenicity of a novel therapeutic hepatitis C virus (HCV) genotype 1a/1b consensus DNA vaccine, INO-8000, encoding HCV NS3, NS4A, NS4B, and NS5A proteins alone or co-administered with DNA-encoding IL12 (INO-9012), a human cytokine that stimulates cellular immune function, in individuals with chronic hepatitis C. This was a phase I, multisite dose-escalation trial with an expansion cohort evaluating doses of 0, 0.3, 1.0, and 3.0 mg of INO-9012 (IL12 DNA) as an addition to 6.0 mg of (INO-8000; HCV DNA vaccine). Vaccines were administered by intramuscular injection followed by electroporation at study entry and at weeks 4, 12, and 24. HCV-specific CD4+ and CD8+ T-cell immune responses were measured by IFNγ ELISpot and flow cytometry-based assays. Transient, mild-to-moderate injection site reactions unrelated to IL12 DNA dose were common. Increases in HCV-specific IFNγ production occurred in 15/20 (75%) participants. Increases in the frequency of HCV-specific CD4+ and CD8+ T cells occurred at all dose levels, with the greatest increases seen at 1.0 mg of INO-9012. HCV-specific CD8+ and CD4+ T-cell activities increased in 16/18 (89%) and 14/17 (82%) participants with available data, respectively. The vaccine regimen was safe and induced HCV-specific CD4+ and CD8+ cellular immune responses of modest magnitude in most HCV-infected participants. The addition of 1.0 mg of IL12 DNA provided the best enhancement of immune responses. The vaccine regimen had little effect on controlling HCV viremia. PREVENTION RELEVANCE: The administration of IL12 DNA along with a hepatitis C viral antigen DNA vaccine enhanced the HCV-specific immune responses induced by the vaccine in individuals with chronic hepatitis C, an important cause of hepatocellular carcinoma. IL12 could be an effective adjuvant in vaccines targeting HCV and other oncogenic viruses.

Indexed as

Carcinoma, HepatocellularHepatitis CHepatitis C, ChronicLiver NeoplasmsVaccines, DNADNAHepacivirusHumansInterleukin-12PlasmidsViral Nonstructural ProteinsDNAInterleukin-12rocakinogene sifuplasmidVaccines, DNAViral Nonstructural Proteins

Identifiers

PMID36534786
PMCPMC9992130
OpenAlexW4312018500

What OpenQuestion holds

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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.