Evidence map›Paper›PMID 21603651›Full record

Trial reportPloS one2011

In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers.

Sandhya Vasan, Arlene Hurley, Sarah J Schlesinger, Drew Hannaman, David F Gardiner, Daniel P Dugin, Mar Boente-Carrera, Roselle Vittorino, Marina Caskey, Johanne Andersen and 15 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 111 papers.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed
28.5field-weighted citation impact, top 1% 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.

NCT00545987 phase1completednot on this map

Evaluation of Local and Systemic Reactogenicity Following Serial Administration of ADVAX, a Clade C DNA Vaccine, ADVAX e/g + ADVAX p/N-t, by Ichor TriGrid™ in Vivo Electroporation to HIV-Uninfected, Healthy Volunteers

TypeinterventionalSponsorRockefeller UniversityRan2007 to 2011Enrolled40ConditionsHIV InfectionsArmsTriGrid™ Delivery System, conventional intramuscular injection
NCT01493154 phase1terminatednot on this mapstarted 2012, after this paper: background citation

A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer Patients

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2012 to 2015Enrolled2ConditionsHead and Neck CancerArmsDNA Vaccine, Cyclophosphamide
NCT05102643 phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

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

111 citing papers in PubMed, 185 citations in OpenAlex.

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51 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

25 authors at 8 institutions in 2 countries.

Sandhya VasanAaron Diamond AIDS Research Center, New York, New York, United States of America. svasan@adarc.org
Arlene Hurley
Sarah J Schlesinger
Drew Hannaman
David F Gardiner
Daniel P Dugin
Mar Boente-Carrera
Roselle Vittorino
Marina Caskey
Johanne Andersen
Yaoxing Huang
Josephine H Cox
Tony Tarragona-Fiol
Dilbinder K Gill
Hannah Cheeseman
Lorna Clark
Len Dally
Carol Smith
Claudia Schmidt
Harriet H Park
Jakub T Kopycinski
Jill Gilmour
Patricia Fast
Robert Bernard
David D Ho
Aaron Diamond AIDS Research Center · USInternational AIDS Vaccine Initiative · USImperial College London · GBRockefeller University · USEmmes (United States) · USIchor Medical Systems (United States) · USInternational HIV/AIDS Alliance · GBNew York Audio Productions (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDNA-based vaccines have been safe but weakly immunogenic in humans to date. METHODS AND

findingsWe sought to determine the safety, tolerability, and immunogenicity of ADVAX, a multigenic HIV-1 DNA vaccine candidate, injected intramuscularly by in vivo electroporation (EP) in a Phase-1, double-blind, randomized placebo-controlled trial in healthy volunteers. Eight volunteers each received 0.2 mg, 1 mg, or 4 mg ADVAX or saline placebo via EP, or 4 mg ADVAX via standard intramuscular injection at weeks 0 and 8. A third vaccination was administered to eleven volunteers at week 36. EP was safe, well-tolerated and considered acceptable for a prophylactic vaccine. EP delivery of ADVAX increased the magnitude of HIV-1-specific cell mediated immunity by up to 70-fold over IM injection, as measured by gamma interferon ELISpot. The number of antigens to which the response was detected improved with EP and increasing dosage. Intracellular cytokine staining analysis of ELISpot responders revealed both CD4+ and CD8+ T cell responses, with co-secretion of multiple cytokines.

conclusionsThis is the first demonstration in healthy volunteers that EP is safe, tolerable, and effective in improving the magnitude, breadth and durability of cellular immune responses to a DNA vaccine candidate.

trial registrationClinicalTrials.gov NCT00545987.

Indexed as

AdolescentAdultAIDS VaccinesCytokinesDouble-Blind MethodElectroporationFemaleHIV-1HumansImmunity, CellularInjections, IntramuscularMaleMiddle AgedT-LymphocytesVaccines, DNAYoung AdultAIDS VaccinesCytokinesVaccines, DNA

Identifiers

PMID21603651
PMCPMC3095594
OpenAlexW1995630383

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.