Evidence map›Paper›PMID 22590502›Full record

ArticlePloS one2012

Single DermaVir immunization: dose-dependent expansion of precursor/memory T cells against all HIV antigens in HIV-1 infected individuals.

Julianna Lisziewicz, Nyasha Bakare, Sandra A Calarota, Dénes Bánhegyi, János Szlávik, Eszter Ujhelyi, Enikő R Tőke, Levente Molnár, Zsolt Lisziewicz, Brigitte Autran and 1 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in PloS one, 2012. 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 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.8field-weighted citation impact, top 4% 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.

NCT00711230 phase2completednot on this map

A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients

TypeinterventionalSponsorGenetic ImmunityRan2008 to 2015Enrolled36ConditionsHIV InfectionArmsDermaVir, Placebo
NCT00712530 phase1completednot on this map

A Phase I Study to Evaluate the Tolerability and Safety of LC002, a DermaVir Vaccine, in HIV-1-infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)

TypeinterventionalSponsorGenetic ImmunityRan2005 to 2006Enrolled9ConditionsHIV InfectionArmsDermaVir, HAART
NCT00918840 completednot on this map

Antiretroviral-Sparing Concept: An Exploratory Phase II, Randomized, Single Blind Placebo-Controlled Study to Investigate the Effect of Therapeutic Immunization on the Quantity of HIV-Specific T Cell Precursors During Highly Active Antiretroviral Therapy Followed by Analytical Treatment Interruption

TypeobservationalSponsorGenetic ImmunityRan2009 to 2011Enrolled16ConditionsHIV InfectionArmsDermaVir, Placebo, HAART
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 69 citations in OpenAlex.

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  12. Detecting cancers through tumor-activatable minicircles that lead to a detectable blood biomarker.Proceedings of the National Academy of Sciences of the United States of America · 2015
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  18. A nanoparticle formulation that selectively transfects metastatic tumors in mice.Proceedings of the National Academy of Sciences of the United States of America · 2013
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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

11 authors at 4 institutions in 3 countries.

Julianna LisziewiczGenetic Immunity, Budapest, Hungary and Genetic Immunity Inc, Mclean, Virginia, United States of America. lisziewj@geneticimmunity.com
Nyasha Bakare
Sandra A Calarota
Dénes Bánhegyi
János Szlávik
Eszter Ujhelyi
Enikő R Tőke
Levente Molnár
Zsolt Lisziewicz
Brigitte Autran
Franco Lori
Research Institute for Genetic and Human Therapy · USUnified Szent István and Szent László Hospital · HUImmunité et Cancer · FRPitié-Salpêtrière Hospital · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe GIHU004 study was designed to evaluate the safety and immunogenicity of three doses of DermaVir immunization in HIV-infected subjects on fully suppressive combination antiretroviral therapy (cART). METHODOLOGY/PRINCIPAL

findingsThis first-in-human dose escalation study was conducted with three topical DermaVir doses targeted to epidermal Langerhans cells to express fifteen HIV antigens in draining lymph nodes: 0.1 mg DNA targeted to two, 0.4 mg and 0.8 mg DNA targeted to four lymph nodes. Particularly, in the medium dose cohort 0.1 mg DNA was targeted per draining lymph node via ∼8 million Langerhans cells located in 80 cm(2) epidermis area. The 28-days study with 48-week safety follow-up evaluated HIV-specific T cell responses against Gag p17, Gag p24 and Gag p15, Tat and Rev antigens. DermaVir-associated side effects were mild, transient and not dose-dependent. Boosting of HIV-specific effector CD4(+) and CD8(+) T cells expressing IFN-gamma and IL-2 was detected against several antigens in every subject of the medium dose cohort. The striking result was the dose-dependent expansion of HIV-specific precursor/memory T cells with high proliferation capacity. In low, medium and high dose cohorts this HIV-specific T cell population increased by 325-, 136,202 and 50,759 counts after 4 weeks, and by 3,899, 9,878 and 18,382 counts after one year, respectively, compared to baseline. CONCLUSIONS/SIGNIFICANCE: Single immunization with the DermaVir candidate therapeutic vaccine was safe and immunogenic in HIV-infected individuals. Based on the potent induction of Gag, Tat and Rev-specific memory T cells, especially in the medium dose cohort, we speculate that DermaVir boost T cell responses specific to all the 15 HIV antigens expressed from the single DNA. For durable immune reactivity repeated DermaVir immunization might be required since the frequency of DermaVir-boosted HIV-specific memory T cells decreased during the 48-week follow up.

trial registrationClinicalTrial.gov NCT00712530.

Indexed as

Immunologic MemoryAdolescentAdultAIDS VaccinesAntigens, ViralCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCohort StudiesDose-Response Relationship, ImmunologicEpidermisFemaleFollow-Up StudiesHIV-1HIV InfectionsHumansInterferon-gammaAIDS VaccinesAntigens, ViralDermaVirInterferon-gamma

Identifiers

PMID22590502
PMCPMC3348904
OpenAlexW2059262899

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.