Evidence map›Paper›PMID 30496299›Full record

Trial reportPloS one2018

Optimizing the immunogenicity of HIV prime-boost DNA-MVA-rgp140/GLA vaccines in a phase II randomized factorial trial design.

Edna O Viegas, Arne Kroidl, Patricia J Munseri, Marco Missanga, Charlotta Nilsson, Nelson Tembe, Asli Bauer, Agricola Joachim, Sarah Joseph, Philipp Mann and 17 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 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

27 authors at 10 institutions in 7 countries.

Edna O ViegasInstituto Nacional de Saúde (INS), Maputo, Mozambique.ORCID 0000-0003-4691-9920
Arne KroidlDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany.
Patricia J MunseriMuhimbili University of Health and Allied Sciences (MUHAS), Department of Internal Medicine, Dar es Salaam, Tanzania.
Marco MissangaNational Institute for Medical Research, Mbeya Medical Research Center (NIMR-MMRC), Mbeya, Tanzania.
Charlotta NilssonKarolinska Institutet, Department of Laboratory Medicine, Huddinge, Sweden.
Nelson TembeInstituto Nacional de Saúde (INS), Maputo, Mozambique.
Asli BauerDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany.
Agricola JoachimMuhimbili University of Health and Allied Sciences (MUHAS), Department of Microbiology and Immunology, Dar es Salaam, Tanzania.
Sarah JosephMRC Clinical Trials Unit at UCL, London, United Kingdom.
Philipp MannDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany.
Christof GeldmacherDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany.
Sue FleckMRC Clinical Trials Unit at UCL, London, United Kingdom.
Wolfgang StöhrMRC Clinical Trials Unit at UCL, London, United Kingdom.
Gabriella ScarlattiIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS), San Raffaele Scientific Institute, Viral Evolution and Transmission Unit, Milan, Italy.
Said AboudMuhimbili University of Health and Allied Sciences (MUHAS), Department of Microbiology and Immunology, Dar es Salaam, Tanzania.
Muhammad BakariMuhimbili University of Health and Allied Sciences (MUHAS), Department of Internal Medicine, Dar es Salaam, Tanzania.
Leonard MabokoNational Institute for Medical Research, Mbeya Medical Research Center (NIMR-MMRC), Mbeya, Tanzania.
Michael HoelscherDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany.
Britta WahrenKarolinska Institutet, Department of Microbiology, Tumor and Cell Biology, Stockholm, Sweden.
Merlin L RobbThe US Military HIV Research Program, the Henry M Jackson Foundation for the Advancement of Military Medicine and Walter Reed Army Institute of Research, Silver Spring, MD, United States.
Jonathan WeberImperial College London, London, United Kingdom.ORCID 0000-0001-5696-0340
Sheena McCormackMRC Clinical Trials Unit at UCL, London, United Kingdom.
Gunnel BiberfeldPublic Health Agency of Sweden (PHAS), Department of Microbiology, Solna, Sweden.
Ilesh V JaniInstituto Nacional de Saúde (INS), Maputo, Mozambique.
Eric SandströmKarolinska Institutet at Södersjukhuset, Venhälsan, Stockholm, Sweden.
Eligius LyamuyaMuhimbili University of Health and Allied Sciences (MUHAS), Department of Microbiology and Immunology, Dar es Salaam, Tanzania.
TaMoVac study group
Muhimbili University of Health and Allied Sciences · TZMRC Clinical Trials Unit at UCL · GBNational Institute for Medical Research · TZGerman Center for Infection Research · DEInstituto Nacional de Saúde · MZKarolinska Institutet · SEPublic Health Agency of Sweden · SEHenry M. Jackson Foundation · USImperial College London · GBIstituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

Medical Research Council MC_U122861400Medical Research Council MC_UU_12023/1Medical Research Council MC_UU_12023/23Wellcome Trust
6 · The paper itself

Abstract

backgroundWe evaluated the safety and immunogenicity of (i) an intradermal HIV-DNA regimen given with/without intradermal electroporation (EP) as prime and (ii) the impact of boosting with modified vaccinia virus Ankara (HIV-MVA) administered with or without subtype C CN54rgp140 envelope protein adjuvanted with Glucopyranosyl Lipid A (GLA-AF) in volunteers from Tanzania and Mozambique.

methodsHealthy HIV-uninfected adults (N = 191) were randomized twice; first to one of three HIV-DNA intradermal priming regimens by needle-free ZetaJet device at weeks 0, 4 and 12 (Group I: 2x0.1mL [3mg/mL], Group II: 2x0.1mL [3mg/mL] plus EP, Group III: 1x0.1mL [6mg/mL] plus EP). Second the same volunteers received 108 pfu HIV-MVA twice, alone or combined with CN54rgp140/GLA-AF, intramuscularly by syringe, 16 weeks apart. Additionally, 20 volunteers received saline placebo.

resultsVaccinations and electroporation did not raise safety concerns. After the last vaccination, the overall IFN-γ ELISpot response rate to either Gag or Env was 97%. Intradermal electroporation significantly increased ELISpot response rates to HIV-DNA-specific Gag (66% group I vs. 86% group II, p = 0.026), but not to the HIV-MVA vaccine-specific Gag or Env peptide pools nor the magnitude of responses. Co-administration of rgp140/GLA-AF with HIV-MVA did not impact the frequency of binding antibody responses against subtype B gp160, C gp140 or E gp120 antigens (95%, 99%, 79%, respectively), but significantly enhanced the magnitude against subtype B gp160 (2700 versus 300, p<0.001) and subtype C gp140 (24300 versus 2700, p<0.001) Env protein. At relatively low titers, neutralizing antibody responses using the TZM-bl assay were more frequent in vaccinees given adjuvanted protein boost.

conclusionIntradermal electroporation increased DNA-induced Gag response rates but did not show an impact on Env-specific responses nor on the magnitude of responses. Co-administration of HIV-MVA with rgp140/GLA-AF significantly enhanced antibody responses.

Indexed as

Immunogenicity, VaccineAdministration, CutaneousAdultAIDS VaccinesAntibodies, NeutralizingElectroporationenv Gene Products, Human Immunodeficiency VirusFemaleGlucosidesHealthy VolunteersHIV-1HIV AntibodiesHIV InfectionsHumansImmunization, SecondaryLipid AAIDS VaccinesAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency Virusglucopyranosyl lipid-AGlucosidesgp140 envelope protein, Human immunodeficiency virus 1HIV AntibodiesLipid AMVA vaccineVaccines, DNAViral Vaccines

Identifiers

PMID30496299
PMCPMC6264478
OpenAlexW2902100811

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.