Evidence map›Paper›PMID 39088271›Full record

Trial reportJCI insight2024

Focusing HIV-1 Gag T cell responses to highly conserved regions by DNA vaccination in HVTN 119.

Spyros A Kalams, Barbara K Felber, James I Mullins, Hyman M Scott, Mary A Allen, Stephen C De Rosa, Jack Heptinstall, Georgia D Tomaras, Jiani Hu, Allan C DeCamp and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in JCI insight, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03181789 (A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT03181789 phase1completednot on this map

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2020Enrolled56ConditionsHIV InfectionsArmsp24CE1/2 pDNA Vaccine, p55^gag pDNA Vaccine, IL-12 pDNA Adjuvant, Placebo, Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
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

19 authors.

Spyros A KalamsDivision of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Barbara K FelberHuman Retrovirus Pathogenesis Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute at Frederick, Frederick, Maryland, USA.
James I MullinsDepartments of Microbiology, Medicine and Global Health, University of Washington, Seattle, Washington, USA.
Hyman M ScottSan Francisco Department of Public Health, San Francisco, California, USA.
Mary A AllenDivision of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Rockville, Maryland, USA.
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Jack HeptinstallDuke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics, and Microbiology, Durham, North Carolina, USA.
Georgia D TomarasDuke Center for Human Systems Immunology, Departments of Surgery, Integrative Immunobiology, Molecular Genetics, and Microbiology, Durham, North Carolina, USA.
Jiani HuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Allan C DeCampVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Margherita RosatiHuman Retrovirus Pathogenesis Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute at Frederick, Frederick, Maryland, USA.
Jenifer BearHuman Retrovirus Pathogenesis Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute at Frederick, Frederick, Maryland, USA.
Michael N PensieroDivision of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Rockville, Maryland, USA.
John EldridgeAuro Vaccines LLC (formerly Profectus BioSciences, Inc.), Pearl River, New York, USA.
Michael A EganAuro Vaccines LLC (formerly Profectus BioSciences, Inc.), Pearl River, New York, USA.
Drew HannamanIchor Medical Systems, San Diego, California, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
George N PavlakisHuman Retrovirus Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute at Frederick, Frederick, Maryland, USA.
HIV Vaccine Trials Network 119(HVTN 119) Study Team

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069496
6 · The paper itself

Abstract

BACKGROUNDAn HIV-1 DNA vaccine composed of 7 highly conserved, structurally important elements (conserved elements, CE) of p24Gag was tested in a phase I randomized, double-blind clinical trial (HVTN 119, NCT03181789) in people without HIV. DNA vaccination of CE prime/CE+p55Gag boost was compared with p55Gag.METHODSTwo groups (n = 25) received 4 DNA vaccinations (CE/CE+p55Gag or p55Gag) by intramuscular injection/electroporation, including IL-12 DNA adjuvant. The placebo group (n = 6) received saline. Participants were followed for safety and tolerability. Immunogenicity was assessed for T cell and antibody responses.RESULTSBoth regimens were safe and generally well tolerated. The p24CE vaccine was immunogenic and significantly boosted by CE+p55Gag (64% CD4+, P = 0.037; 42% CD8+, P = 0.004). CE+p55Gag induced responses to 5 of 7 CE, compared with only 2 CE by p55Gag DNA, with a higher response to CE5 in 30% of individuals (P = 0.006). CE+p55Gag induced significantly higher CD4+ CE T cell breadth (0.68 vs. 0.22 CE; P = 0.029) and a strong trend for overall T cell breadth (1.14 vs. 0.52 CE; P = 0.051). Both groups developed high cellular and humoral responses. p24CE vaccine-induced CD4+ CE T cell responses correlated (P = 0.007) with p24Gag antibody responses.CONCLUSIONThe CE/CE+p55Gag DNA vaccine induced T cell responses to conserved regions in p24Gag, increasing breadth and epitope recognition throughout p55Gag compared with p55Gag DNA. Vaccines focusing immune responses by priming responses to highly conserved regions could be part of a comprehensive HIV vaccine strategy.TRIAL REGISTRATIONClinical Trials.gov NCT03181789FUNDINGHVTN, NIAID/NIH.

Indexed as

AIDS Vaccinesgag Gene Products, Human Immunodeficiency VirusHIV-1HIV InfectionsVaccines, DNAAdultCD4-Positive T-LymphocytesDouble-Blind MethodFemaleHIV AntibodiesHumansImmunogenicity, VaccineMaleMiddle AgedT-LymphocytesVaccinationAIDS Vaccinesgag Gene Products, Human Immunodeficiency VirusHIV AntibodiesVaccines, DNAAIDS/HIVAIDS vaccineClinical trials

Identifiers

PMID39088271
PMCPMC11466283

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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.